Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-01-23 @ 4:19 PM
Study NCT ID:
NCT00497159
Status:
COMPLETED
Last Update Posted:
2015-06-08
First Post:
2007-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Novel Drug Dimebon in Patients With Huntington's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006816', 'term': 'Huntington Disease'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D002819', 'term': 'Chorea'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C010119', 'term': 'latrepirdine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'dispFirstSubmitDate': '2015-05-16', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-16', 'studyFirstSubmitDate': '2007-07-03', 'dispFirstSubmitQcDate': '2015-05-16', 'studyFirstSubmitQcDate': '2007-07-03', 'dispFirstPostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "To assess the safety and tolerability of Dimebon during 3 months of treatment in subjects with Huntington's Disease.", 'timeFrame': '90 days'}], 'secondaryOutcomes': [{'measure': "To assess the impact of Dimebon during 3 months of treatment on cognitive, motor, and overall function in subjects with Huntington's Disease.", 'timeFrame': '90 days'}, {'measure': 'To assess the pharmacokinetics of Dimebon.', 'timeFrame': '90 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Trial of Dimebon to treat patients with mild-to-moderate Huntington's disease."], 'conditions': ["Huntington's Disease"]}, 'referencesModule': {'references': [{'pmid': '20142523', 'type': 'DERIVED', 'citation': 'Kieburtz K, McDermott MP, Voss TS, Corey-Bloom J, Deuel LM, Dorsey ER, Factor S, Geschwind MD, Hodgeman K, Kayson E, Noonberg S, Pourfar M, Rabinowitz K, Ravina B, Sanchez-Ramos J, Seely L, Walker F, Feigin A; Huntington Disease Study Group DIMOND Investigators. A randomized, placebo-controlled trial of latrepirdine in Huntington disease. Arch Neurol. 2010 Feb;67(2):154-60. doi: 10.1001/archneurol.2009.334.'}], 'seeAlsoLinks': [{'url': 'http://www.huntington-study-group.org', 'label': 'The Huntington Study Group is a non-profit group of physicians and health care providers from medical centers in the US, Canada, Europe, and Australia, experienced in the care of HD patients and dedicated to clinical research of HD. Click for more info.'}]}, 'descriptionModule': {'briefSummary': "This study will evaluate the safety of 3 months of Dimebon dosing and the efficacy of Dimebon in improving cognitive, motor, and overall function in subjects with Huntington's Disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '29 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical features of HD and a confirmatory family history of HD, and/or genetically confirmed HD;\n* Able to take medication (capsules) by mouth.\n\nExclusion Criteria:\n\n* Clinical evidence of unstable medical illness;\n* Females who are pregnant or lactating or who intend to become pregnant during the study period.'}, 'identificationModule': {'nctId': 'NCT00497159', 'acronym': 'DIMOND', 'briefTitle': "A Study of the Novel Drug Dimebon in Patients With Huntington's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Medivation, Inc.'}, 'officialTitle': "A Multi-Center, Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's Disease", 'orgStudyIdInfo': {'id': 'DIM05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Placebo', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Dimebon', 'interventionNames': ['Drug: Dimebon']}], 'interventions': [{'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo TID x 90 days', 'armGroupLabels': ['1']}, {'name': 'Dimebon', 'type': 'DRUG', 'description': 'Dimebon 20 mg TID x 90 days', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14620', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Huntington Study Group', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Karl Kieburtz, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huntington Study Group, University of Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medivation, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Huntington Study Group', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}