Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-01-24 @ 8:03 PM
Study NCT ID:
NCT00823368
Status:
COMPLETED
Last Update Posted:
2013-07-31
First Post:
2009-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarker Testing and DNA Collection in Subjects Participating in Protocol 22001
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005600', 'term': 'Fragile X Syndrome'}], 'ancestors': [{'id': 'D038901', 'term': 'X-Linked Intellectual Disability'}, {'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D025064', 'term': 'Sex Chromosome Disorders'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA from blood,plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'lastUpdateSubmitDate': '2013-07-30', 'studyFirstSubmitDate': '2009-01-13', 'studyFirstSubmitQcDate': '2009-01-14', 'lastUpdatePostDateStruct': {'date': '2013-07-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in plasma proteins with treatment', 'timeFrame': 'After 4 weeks of treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['fragile X syndrome', 'biomarkers'], 'conditions': ['Fragile X Syndrome']}, 'descriptionModule': {'briefSummary': 'The subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001 will be offered participation in 22001A which will evaluate secreted protein before and after treatment with STX209 and placebo to determine if they correlate with effectiveness of treatment or susceptibility to treatment with STX209. These same subjects will also be asked to contribute a blood sample for DNA (deoxyribonucleic acid) collection. The investigators will study the DNA to determine if STX209 works better in people with specific gene variations, or to find new gene variations that predict how well STX209 works.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Fragile x syndrome subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001\n\nExclusion Criteria:\n\n* Subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001'}, 'identificationModule': {'nctId': 'NCT00823368', 'briefTitle': 'Biomarker Testing and DNA Collection in Subjects Participating in Protocol 22001', 'organization': {'class': 'INDUSTRY', 'fullName': 'Seaside Therapeutics, Inc.'}, 'officialTitle': 'Biomarker Testing and DNA Collection in Subjects Participating in a Double-Blind, Placebo-Controlled, Crossover, Flexible-Dose Evaluation of the Efficacy, Safety, and Tolerability of STX209 in the Treatment of Irritability in Subjects With Fragile X Syndrome', 'orgStudyIdInfo': {'id': '22001A'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arbaclofen followed by Placebo', 'interventionNames': ['Drug: STX209']}, {'label': 'Placebo followed by Arbaclofen', 'interventionNames': ['Drug: STX209']}], 'interventions': [{'name': 'STX209', 'type': 'DRUG', 'armGroupLabels': ['Arbaclofen followed by Placebo', 'Placebo followed by Arbaclofen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Southwest Autism Research & Resource Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California-Los Angeles Neuropsychiatric Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'M.I.N.D. Institute', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Riley Hospital for Children', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '10314', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'NYS Institute for Basic Research in Developmental Disabilities', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina Neurosciences Hospital', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '19063', 'city': 'Media', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Suburban Research Associates', 'geoPoint': {'lat': 39.91678, 'lon': -75.38769}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Kennedy Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77090', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Red Oaks Psychiatry Associates, PA', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Elizabeth Berry-Kravis, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rush University Medical Center'}, {'name': 'Randi Hagerman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.I.N.D. Institute'}, {'name': 'Craig Erikson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riley Hospital for Children'}, {'name': 'Bryan King, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seattle Children's Hospital"}, {'name': 'James McCracken, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}, {'name': 'Jonathan Picker, MBChB, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}, {'name': 'Linmarie Sikich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina Neurosciences Hospital'}, {'name': 'Jeremy Veenstra-VanderWeele, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt Kennedy Center'}, {'name': 'Ted Brown, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYS Institute for Basic Research in Developmental Disabilities'}, {'name': 'Lawrence Ginsberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Red Oaks Psychiatry Associates, PA'}, {'name': 'Shivkumar Hatti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Suburban Research Associates'}, {'name': 'Raun Melmed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southwest Autism Research & Resource Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seaside Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}