Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-01-05 @ 6:04 PM
Study NCT ID:
NCT04082832
Status:
UNKNOWN
Last Update Posted:
2019-11-06
First Post:
2019-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CuATSM Compared With Placebo for Treatment of ALS/MND
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-07-25', 'releaseDate': '2022-08-29'}], 'estimatedResultsFirstSubmitDate': '2022-08-29'}}, '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)'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'placebo controlled'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'ANCOVA will be used to compare efficacy endpoints between CuATSM and placebo groups'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-04', 'studyFirstSubmitDate': '2019-09-02', 'studyFirstSubmitQcDate': '2019-09-06', 'lastUpdatePostDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Revised ALS Functional Rating Scale (ALSFRS-R) total score (range: 48 [best] to 0 [worst])', 'timeFrame': '24 weeks', 'description': 'assessment of disease severity'}, {'measure': 'Edinburgh Cognitive and Behavioral Amyotrophic Lateral Sclerosis Screen (ECAS) total score (range: 136 [best] to 0 [worst])', 'timeFrame': '24 weeks', 'description': 'assessment of cognitive function'}], 'secondaryOutcomes': [{'measure': 'seated slow vital capacity (SVC)', 'timeFrame': '24 weeks', 'description': 'assessment of respiratory function'}, {'measure': 'rate of adverse events', 'timeFrame': '24 weeks', 'description': 'tolerability assessment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Amyotrophic Lateral Sclerosis']}, 'descriptionModule': {'briefSummary': 'Multicenter, randomized, double-blind, placebo controlled study to assess the tolerabilty and efficacy of CuATSM in patients with ALS/MND. Patients will be randomized 1:1 to CuATSM or placebo for 6 x 28-day cycles (24 weeks) of treatment.', 'detailedDescription': 'Patients will be randomized 1:1 to CuATSM or placebo for 6 x 28-day cycles (24 weeks) of treatment. Study drug is administered orally, once a day in fasted state (before breakfast). Assessments for safety (physical examination, vital signs, hematology, serum chemistry adverse events) will be conducted at baseline and following each cycle of treatment. Assessments for efficacy (Revised ALS Functional Rating Scale \\[ASLFRS-R\\] score, and Edinburgh Cognitive and Behavioral Amyotrophic Lateral Sclerosis Screen \\[ECAS\\] score, and seated slow vital capacity \\[SVC\\]) will be conducted at baseline and following 2, 4 and 6 cycles of treatment. Analysis of covariance (ANCOVA) will be used to compare efficacy endpoints between CuATSM and placebo groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signed informed consent\n* familial or sporadic ALS/MNS by Awaji-shima Consensus Recommendations\n* not taking riluzole or on stable dose of riluzole for 4 weeks prior to screening visit\n* no prior exposure to agents other than riluzole for treatment of ALS\n* adequate bone marrow reserve, renal and liver function\n* women of childbearing potential must have a negative pregnancy test and be non-lactating\n* women and men with partners of childbearing potential must take effective contraception while on treatment\n\nExclusion Criteria:\n\n* presence of a gastrointestinal disorder (eg, malabsorption) that might jeopardize intestinal absorption of study drug\n* inability to perform seated SVC\n* known immune compromising illness or treatment\n* drug abuse or alcoholism\n* clinically significant or active cardiovascular disease\n* acute or chronic infection\n* diagnosis of malignancy within 2 years prior to screening\n* dementia that may affect patient understanding and/or compliance with study requirements and procedures\n* current use of strong inducers or inhibitors of CYPs 2C19 and 2D6\n* current us of medications (other than riluzole) that are metabolized predominantly by CYP 1A2'}, 'identificationModule': {'nctId': 'NCT04082832', 'briefTitle': 'CuATSM Compared With Placebo for Treatment of ALS/MND', 'organization': {'class': 'INDUSTRY', 'fullName': 'Collaborative Medicinal Development Pty Limited'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Cu(II)ATSM in Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease', 'orgStudyIdInfo': {'id': 'CMD-2019-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cu(II)ATSM', 'description': 'Cu(II)ATSM Powder for Oral Suspension, 36 mg, to be reconstituted with Diluent (15 mL of sugar-free flavored pharmaceutical syrup) to provide an oral suspension for immediate consumption. Specified dose is 72 mg (2 bottles) taken fasting, before breakfast each day.', 'interventionNames': ['Drug: Cu(II)ATSM']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Powder for Oral Suspension', 'description': 'Placebo Powder for Oral Suspension, to be reconstituted with Diluent (15 mL of sugar-free flavored pharmaceutical syrup) to provide an oral suspension for immediate consumption. Specified dose is 72 mg (2 bottles) taken fasting, before breakfast each day.', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Cu(II)ATSM', 'type': 'DRUG', 'description': 'oral suspension', 'armGroupLabels': ['Cu(II)ATSM']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'oral suspension', 'armGroupLabels': ['Placebo Powder for Oral Suspension']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Macquarie', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Dominic Rowe, MD', 'role': 'CONTACT'}], 'facility': 'Macquarie University'}], 'centralContacts': [{'name': 'Kay Noel, PhD', 'role': 'CONTACT', 'email': 'Kay.Noel@colMedDev.com', 'phone': '(415) 444 9600'}, {'name': 'Craig Rosenfeld, MD', 'role': 'CONTACT', 'email': 'CraigR@ColMedDev.com', 'phone': '(415) 444 9600'}], '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'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-08-29', 'type': 'RELEASE'}, {'date': '2023-07-25', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Collaborative Medicinal Development Pty Limited'}}}}