Viewing Study NCT04103892

Home

Certify Doc

Genes

Clinical Trials

CompTox

DrugMatrix

Open Targets

Products

Support

Bugs

Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 3:38 PM

Ignite Modification Date: 2026-01-09 @ 2:01 AM

Study NCT ID: NCT04103892

Status: COMPLETED

Last Update Posted: 2025-10-14

First Post: 2019-09-09

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: A Study of CLE-100 (Oral Esketamine) in Addition to Standard Antidepressant Drug for Major Depressive Disorder - CLEO Study

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'myriam.belahcen@clexio.com', 'phone': '972-733318704', 'title': 'Regulatory Affairs Lead', 'organization': 'Clexio Biosciences Ltd'}, 'certainAgreement': {'otherDetails': 'After the multicenter publication or 18 months after completion of the Study, whichever occurs first, Institution may itself publish the results of its data from the Study. Institution and Principal Investigator shall provide Sponsor with an advance copy of any proposed publication or oral presentation at least 60 days prior to the planned date of submission or presentation and Sponsor shall have 60 days to review the proposed publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Part A: 2 weeks; Part B: 6 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Part A - CLE-100 (Oral Esketamine)', 'description': 'Part A: 1 oral tablet of CLE-100 once daily for 1 week.\n\nCLE-100: 1 tablet of CLE-100 administered once daily', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 6, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part A - Placebo', 'description': 'Part A: 1 oral tablet of Placebo once daily for 1 week.\n\nplacebo: 1 tablet of placebo administered once daily', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part B - CLE-100 (Oral Esketamine)', 'description': 'Part B: 1 oral tablet of CLE-100 once daily for 4 weeks.\n\nCLE-100: 1 tablet of CLE-100 administered once daily', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 37, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part B - Placebo', 'description': 'Part B: 1 oral tablet of Placebo once daily for 4 weeks.\n\nplacebo: 1 tablet of placebo administered once daily', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 23, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Blood pressure diastolic increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Urine analysis abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Blood pressure systolic increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Osteopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 17, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypersomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypogeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Restless legs syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dissociation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Anger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bradyphrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Enuresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Euphoric mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Micturition urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Tonsillar hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part B - Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B - CLE-100 (Oral Esketamine)', 'description': 'Part B: 1 oral tablet of CLE-100 once daily for 4 weeks.\n\nCLE-100: 1 tablet of CLE-100 administered once daily'}, {'id': 'OG001', 'title': 'Part B - Placebo', 'description': 'Part B: 1 oral tablet of Placebo once daily for 4 weeks.\n\nplacebo: 1 tablet of placebo administered once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.72', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '-9.46', 'spread': '1.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.46', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.26', 'ciLowerLimit': '-4.60', 'ciUpperLimit': '2.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.69', 'statisticalMethod': 'Mixed Models Repeated Measures (MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '29 days', 'description': 'The MADRS is a validated clinician-administered measurement of depression severity commonly used in clinical trials of depression treatments to select subjects and assess efficacy. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS), which is a subset of the ITT Analysis Set, includes all data collected while on study drug for all randomized subjects who received at least 1 dose of study drug during Part B and have both Baseline and at least 1 post-baseline MADRS total score. This Analysis Set serves as the principal analysis set for inference.'}, {'type': 'POST_HOC', 'title': 'Part B - Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score in 2022 Cohort (Corresponding to a Post-acute Phase of the COVID-19 Pandemic)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B - CLE-100 (Oral Esketamine)', 'description': 'Part B: 1 oral tablet of CLE-100 once daily for 4 weeks.\n\nCLE-100: 1 tablet of CLE-100 administered once daily'}, {'id': 'OG001', 'title': 'Part B - Placebo', 'description': 'Part B: 1 oral tablet of Placebo once daily for 4 weeks.\n\nplacebo: 1 tablet of placebo administered once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.96', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '-7.68', 'spread': '1.84', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.28', 'ciLowerLimit': '-9.91', 'ciUpperLimit': '-0.65', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.34', 'statisticalMethod': 'Mixed Models Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '29 days', 'description': 'The MADRS is a validated clinician-administered measurement of depression severity commonly used in clinical trials of depression treatments to select subjects and assess efficacy. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '2022 cohort (corresponding to a post-acute phase of the COVID-19 pandemic) of the Full Analysis Set (FAS) includes all data collected while on study drug for all randomized subjects in 2022 who received at least 1 dose of study drug during Part B and have both Baseline and at least 1 post-baseline MADRS total score. This Analysis Set serves as the principal analysis set for inference.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A - CLE-100 (Oral Esketamine)', 'description': 'Part A: 1 oral tablet of CLE-100 once daily for 1 week.\n\nCLE-100: 1 tablet of CLE-100 administered once daily'}, {'id': 'FG001', 'title': 'Part A - Placebo', 'description': 'Part A: 1 oral tablet of Placebo once daily for 1 week.\n\nplacebo: 1 tablet of placebo administered once daily'}, {'id': 'FG002', 'title': 'Part B - CLE-100 (Oral Esketamine)', 'description': 'Part B: 1 oral tablet of CLE-100 once daily for 4 weeks.\n\nCLE-100: 1 tablet of CLE-100 administered once daily'}, {'id': 'FG003', 'title': 'Part B - Placebo', 'description': 'Part B: 1 oral tablet of Placebo once daily for 4 weeks.\n\nplacebo: 1 tablet of placebo administered once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '72'}, {'groupId': 'FG003', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '66'}, {'groupId': 'FG003', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Requirement of prohibited concomitant medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}, {'value': '146', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A - CLE-100 (Oral Esketamine)', 'description': 'Part A: 1 oral tablet of CLE-100 once daily for 1 week.\n\nCLE-100: 1 tablet of CLE-100 administered once daily'}, {'id': 'BG001', 'title': 'Part A - Placebo', 'description': 'Part A: 1 oral tablet of Placebo once daily for 1 week.\n\nplacebo: 1 tablet of placebo administered once daily'}, {'id': 'BG002', 'title': 'Part B - CLE-100 (Oral Esketamine)', 'description': 'Part B: 1 oral tablet of CLE-100 once daily for 4 weeks.\n\nCLE-100: 1 tablet of CLE-100 administered once daily'}, {'id': 'BG003', 'title': 'Part B - Placebo', 'description': 'Part B: 1 oral tablet of Placebo once daily for 4 weeks.\n\nplacebo: 1 tablet of placebo administered once daily'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.23', 'spread': '9.99', 'groupId': 'BG000'}, {'value': '49.00', 'spread': '7.55', 'groupId': 'BG001'}, {'value': '42.79', 'spread': '13.24', 'groupId': 'BG002'}, {'value': '46.19', 'spread': '13.14', 'groupId': 'BG003'}, {'value': '44.93', 'spread': '12.98', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '101', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '104', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}, {'value': '103', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}, {'value': '144', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-03', 'size': 1138610, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-09-04T17:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Part A - 16 patients, 2 arms, parallel; Part B - 130 patients, 2 arms, parallel'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'dispFirstSubmitDate': '2023-09-05', 'completionDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-28', 'studyFirstSubmitDate': '2019-09-09', 'resultsFirstSubmitDate': '2025-09-04', 'studyFirstSubmitQcDate': '2019-09-24', 'dispFirstPostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-04', 'studyFirstPostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part B - Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score', 'timeFrame': '29 days', 'description': 'The MADRS is a validated clinician-administered measurement of depression severity commonly used in clinical trials of depression treatments to select subjects and assess efficacy. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MDD', 'depression', 'depressive disorder', 'major depression', 'adjunct therapy', 'oral', 'esketamine'], 'conditions': ['Adjunctive Treatment of Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'The clinical trial is a Phase 2, double-blind, randomized, placebo controlled study in Major Depressive Disorder (MDD) participants currently treated with antidepressant therapy. The objective of the study is to assess CLE-100 for the treatment of MDD in participants currently treated with standard antidepressant therapy.', 'detailedDescription': 'CLEO study is performed in two parts (part A and Part B). Part A will be an inpatient study to assess the safety, tolerability, and pharmacokinetics of CLE-100 (oral esketamine) in MDD participants currently treated with an antidepressant drug. It will include a screening phase (up to 35 days), a 1 week inpatient double-blind treatment phase and an outpatient post treatment safety follow-up phase of 1 week after last study drug administration.\n\nPart B will be a study to assess the safety and efficacy of CLE-100 (oral esketamine) in MDD participants currently treated with an antidepressant drug with inadequate response to standard antidepressant therapy.\n\nThe participants will remain on their current antidepressant therapy with no dose change during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Part A - Inclusion Criteria:\n\n1. Male or female between 18 to 60 years of age\n2. Primary diagnosis of MDD, without psychotic features according to DSM-5 and supported by the Mini International Neuropsychiatric Interview (MINI)\n3. MADRS score of at least 18 at Screening\n4. Treatment with stable dose of the current antidepressant therapy for at least 4 weeks for the current major depressive episode (MDE)\n5. Body mass index (BMI) between 18 and 40 kg/m2, inclusive\n6. Is able and competent to read and sign the informed consent form (ICF).\n\nPart A - Exclusion Criteria:\n\n1. History of substance use disorder per DSM-5 criteria, except for tobacco use disorder\n2. History or current diagnosis of bipolar disorder, schizophrenia, schizoaffective disorders, binge eating disorder dementia, delirium, amnesia, or any other significant cognitive disorder\n3. Posttraumatic stress disorder, obsessive compulsive disorder, or any other mental disorder (including personality disorders)\n4. Has any medical condition for which an increase in blood pressure or intracranial pressure poses a serious risk\n5. Female of childbearing potential without appropriate contraceptive means, pregnant or breastfeeding\n\nPart B - Inclusion Criteria:\n\n1. Male or female between 18 to 65 years of age\n2. Primary diagnosis of MDD without psychotic features according to DSM-5 and supported by the Mini International Neuropsychiatric Interview (MINI)\n3. MADRS score of at least 24 at Screening.\n4. At least 2 inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)\n5. Current MDE for at least 12 weeks\n6. BMI between 18 and 40 kg/m2, inclusive.\n7. Is able and competent to read and sign the ICF.\n\nPart B - Exclusion Criteria:\n\n1. Inadequate response to more than 5 treatment courses of antidepressant medication therapy during the current MDE\n2. Current MDE for longer than 5 years.\n3. 3\\. Has a current substance use disorder or history of any substance use disorder per DSM-5 criteria within 12 months prior to Screening, except for tobacco use disorder.\n4. Has a history or current diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorders.\n5. Has dementia, delirium, amnesia, or any other significant cognitive disorder.\n6. Has posttraumatic stress disorder, obsessive compulsive disorder, or any other mental disorder (including personality disorders, eating disorders, etc.).\n7. Has any medical condition for which an increase in blood pressure or intracranial pressure poses a serious risk.\n8. Has been randomized in Part A of this study.\n9. Is a female of childbearing potential pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT04103892', 'briefTitle': 'A Study of CLE-100 (Oral Esketamine) in Addition to Standard Antidepressant Drug for Major Depressive Disorder - CLEO Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Clexio Biosciences Ltd.'}, 'officialTitle': 'A Two-Part Study of CLE-100 as an Adjunct Therapy in Subjects With Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'CLE100-MDD-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A - CLE-100 (oral esketamine)', 'description': 'Part A: 1 oral tablet of CLE-100 once daily for 1 week.', 'interventionNames': ['Drug: CLE-100']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part A - Placebo', 'description': 'Part A: 1 oral tablet of Placebo once daily for 1 week.', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B - CLE-100 (oral esketamine)', 'description': 'Part B: 1 oral tablet of CLE-100 once daily for 4 weeks.', 'interventionNames': ['Drug: CLE-100']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part B - Placebo', 'description': 'Part B: 1 oral tablet of Placebo once daily for 4 weeks.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'CLE-100', 'type': 'DRUG', 'description': '1 tablet of CLE-100 administered once daily', 'armGroupLabels': ['Part A - CLE-100 (oral esketamine)', 'Part B - CLE-100 (oral esketamine)']}, {'name': 'placebo', 'type': 'DRUG', 'description': '1 tablet of placebo administered once daily', 'armGroupLabels': ['Part A - Placebo', 'Part B - Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72712', 'city': 'Bentonville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Clinical Site 126', 'geoPoint': {'lat': 36.37285, 'lon': -94.20882}}, {'zip': '72209', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Clinical Site 120', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72209', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Clinical Site 129', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92805', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site 141', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90706', 'city': 'Bellflower', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site 115', 'geoPoint': {'lat': 33.88168, 'lon': -118.11701}}, {'zip': '94549', 'city': 'Lafayette', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site 132', 'geoPoint': {'lat': 37.88576, 'lon': -122.11802}}, {'zip': '94607', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site 117', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site 113', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '92506', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site 123', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '92705', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site 124', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '95401', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site 142', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site 112', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80209', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Clinical Site 145', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Site 107', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33145', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Site 116', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33014', 'city': 'Miami Gardens', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Site 108', 'geoPoint': {'lat': 25.94204, 'lon': -80.2456}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Site 105', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32807', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Site 137', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30338', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Clinical Site 140', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30030', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Clinical Site 104', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Clinical Site 122', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '21208', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Clinical Site 131', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20877', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Clinical Site 136', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Clinical Site 103', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02131', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Clinical Site 121', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48034', 'city': 'Dearborn Heights', 'state': 'Michigan', 'country': 'United States', 'facility': 'Clinical Site 151', 'geoPoint': {'lat': 42.33698, 'lon': -83.27326}}, {'zip': '63128', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Clinical Site 139', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68526', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Clinical Site 125', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Clinical Site 110', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08053', 'city': 'Marlton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Clinical Site 101', 'geoPoint': {'lat': 39.89122, 'lon': -74.92183}}, {'zip': '08755', 'city': 'Toms River', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Clinical Site 148', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'zip': '10036', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Clinical Site 128', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10312', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Clinical Site 102', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '28601', 'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Clinical Site 111', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '27609', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Clinical Site 143', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '44130', 'city': 'Middleburg Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Clinical Site 138', 'geoPoint': {'lat': 41.36144, 'lon': -81.81291}}, {'zip': '44720', 'city': 'North Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Clinical Site 127', 'geoPoint': {'lat': 40.87589, 'lon': -81.40234}}, {'zip': '19063', 'city': 'Media', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Clinical Site 106', 'geoPoint': {'lat': 39.91678, 'lon': -75.38769}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Clinical Site 118', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Site 114', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Site 109', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '88459', 'city': 'Missouri City', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Site 149', 'geoPoint': {'lat': 29.61857, 'lon': -95.53772}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Site 144', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '84020', 'city': 'Draper', 'state': 'Utah', 'country': 'United States', 'facility': 'Clinical Site 147', 'geoPoint': {'lat': 40.52467, 'lon': -111.86382}}, {'zip': '98007', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Clinical Site 135', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '00918', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Clinical Site 150', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clexio Biosciences Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}