Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-25 @ 5:34 PM
Study NCT ID:
NCT00219804
Status:
COMPLETED
Last Update Posted:
2005-09-22
First Post:
2005-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Tetrabenazine in Chorea
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': 'D013747', 'term': 'Tetrabenazine'}], 'ancestors': [{'id': 'D011807', 'term': 'Quinolizines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'statusVerifiedDate': '2005-09', 'lastUpdateSubmitDate': '2005-09-14', 'studyFirstSubmitDate': '2005-09-14', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ["Huntington's Disease"]}, 'referencesModule': {'references': [{'pmid': '28265459', 'type': 'DERIVED', 'citation': 'Claassen DO, Carroll B, De Boer LM, Wu E, Ayyagari R, Gandhi S, Stamler D. Indirect tolerability comparison of Deutetrabenazine and Tetrabenazine for Huntington disease. J Clin Mov Disord. 2017 Mar 1;4:3. doi: 10.1186/s40734-017-0051-5. eCollection 2017.'}, {'pmid': '20021666', 'type': 'DERIVED', 'citation': 'Frank S. Tetrabenazine as anti-chorea therapy in Huntington disease: an open-label continuation study. Huntington Study Group/TETRA-HD Investigators. BMC Neurol. 2009 Dec 18;9:62. doi: 10.1186/1471-2377-9-62.'}]}, 'descriptionModule': {'briefSummary': "The primary objective of this study was to establish the absolute reduction of chorea in participants with Huntington's disease(HD) treated with tetrabenazine or placebo"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years of age or older\n* suffer from manifest HD as confirmed by genetic testing\n* Meet chorea and total functional capacity scores on Unified Huntington's Disease Rating Scale\n* Meet criteria on Hamilton Depression Rating Scale, Unified Parkinson's Disease Rating Scale dysphagia and dysarthria scale\n* Independently ambulatory\n\nExclusion Criteria\n\n* previous treatment with tetrabenazine\n* unstable or serious medical or psychiatric illness\n* concomitant use identified drugs\n* untreated depression\n* lack of caregiver"}, 'identificationModule': {'nctId': 'NCT00219804', 'briefTitle': 'Efficacy and Safety of Tetrabenazine in Chorea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Prestwick Pharmaceuticals'}, 'officialTitle': "A Randomized, Double-Blind, Placebo-Controlled Study of Tetrabenazine for the Treatment of Huntington's Chorea", 'orgStudyIdInfo': {'id': '103,004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'tetrabenazine or placebo', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Fred Marshall, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Huntington's Study Group"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prestwick Pharmaceuticals', 'class': 'INDUSTRY'}}}}