Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-24 @ 4:39 PM
Study NCT ID:
NCT04313166
Status:
COMPLETED
Last Update Posted:
2022-02-17
First Post:
2020-03-15
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment Continuation Study for Patients With ALS/MND Who Completed Study CMD-2019-001
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C089548', 'term': 'copper (II) diacetyl-di(N(4)-methylthiosemicarbazone)'}, {'id': 'D003300', 'term': 'Copper'}], 'ancestors': [{'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-15', 'studyFirstSubmitDate': '2020-03-15', 'studyFirstSubmitQcDate': '2020-03-15', 'lastUpdatePostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment-related changes in disease severity', 'timeFrame': '24 weeks', 'description': 'Treatment-related changes in disease severity assessed by ALS Functional Rating Scale - Revised (ALSFRS-R)'}], 'secondaryOutcomes': [{'measure': 'Treatment-related changes in cognitive function', 'timeFrame': '24 weeks', 'description': 'Treatment-related changes in cognitive function by Edinburgh Cognitive and Behavioral Assessment (ECAS) score'}, {'measure': 'Treatment-related changed in respiratory function', 'timeFrame': 'SVC', 'description': 'Treatment-related changes in respiratory function by seated slow vital capacity (SVC)'}, {'measure': 'Treatment tolerance', 'timeFrame': '24 weeks', 'description': 'Treatment tolerance based on dose reductions and dose terminations due to adverse events'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Amyotrophic Lateral Sclerosis']}, 'descriptionModule': {'briefSummary': 'Provides up to six months treatment with CuATSM for subjects who have successfully completed study CMD-2019-001', 'detailedDescription': 'Provides up to six months treatment with CuATSM for subjects who have successffulyl completed study CMD-2019-001. \\[This allows subjects randomized to placebo on study CMD-2019-001 to receive up to six months treatment with CuATSM and provides an up to an additional six months treatment with CuATSM for subjects randomized to CuATSM on study CMD-2019-001\\]'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signed informed consent prior to initiation of any study-specific procedures and treatment\n* documented completion of protocol-specified assessments following completion of 24 weeks treatment on study CMD-2019-002\n* Investigator considers patient has been tolerating treatment on study CMD-2019-001 and may benefit from continued treatment with CuATSM\n\nExclusion Criteria:\n\n* not dependent on mechanical ventilation'}, 'identificationModule': {'nctId': 'NCT04313166', 'briefTitle': 'Treatment Continuation Study for Patients With ALS/MND Who Completed Study CMD-2019-001', 'organization': {'class': 'INDUSTRY', 'fullName': 'Collaborative Medicinal Development Pty Limited'}, 'officialTitle': 'A Treatment Continuation Study for Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease Who Have Successfully Complete Study CMD-2019-001', 'orgStudyIdInfo': {'id': 'CMD-2020-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cu(II)ATSM', 'description': 'copper-containing synthetic small molecule', 'interventionNames': ['Drug: Cu(II)ATSM']}], 'interventions': [{'name': 'Cu(II)ATSM', 'type': 'DRUG', 'otherNames': ['diacetylbis(N(4)-methylthiosemicarbazonato) copper(II)'], 'description': 'cooper-containing synthetic small molecule', 'armGroupLabels': ['Cu(II)ATSM']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Macquarie Park', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Macquarie University', 'geoPoint': {'lat': -33.78105, 'lon': 151.12757}}], 'overallOfficials': [{'name': 'Dominic Rowe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Macquarie University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Collaborative Medicinal Development Pty Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}