Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-21 @ 10:44 PM
Study NCT ID:
NCT00642057
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2023-03-24
First Post:
2007-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compassionate Use of Tetrabenazine in the Treatment of Abnormal Movements
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002819', 'term': 'Chorea'}, {'id': 'D020820', 'term': 'Dyskinesias'}], 'ancestors': [{'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'lastUpdateSubmitDate': '2023-03-22', 'studyFirstSubmitDate': '2007-12-28', 'studyFirstSubmitQcDate': '2008-03-21', 'lastUpdatePostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-03-24', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['chorea', 'dyskinesia', 'hyperkinetic'], 'conditions': ['Hyperkinetic Movement Disorders']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.jankovic.org', 'label': "Parkinson's Disease Center and Movement Disorders Clinic"}]}, 'descriptionModule': {'briefSummary': 'Although the results of studies looking at tetrabenazine have shown its effectiveness in the management of hyperkinetic(too much) movement disorders, it has not been made available in the U.S. The drug must be obtained from Cambridge Laboratories, the distributor, using an individual IND (#16,161). The cost of the drug is passed on to the patient. The purpose of the protocol is to provide an efficacious drug, with few side effects, in an attempt to get rid of a variety of incapacitating dyskinesias (abnormal movements).', 'detailedDescription': 'The purpose of the protocol is to provide compassionate use of an efficacious drug, with few side effects, in an attempt to get rid of a variety of incapacitating dyskinesias (abnormal movements).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects evaluated here at Baylor in the PDCMDC demonstrating need for tetrabenazine treatment.\n* Willing to sign informed consent.\n* Willing to comply with procedures required as part of this study.\n\nExclusion Criteria:\n\n* Those subjects unwilling to comply with study requirements.\n* Subjects unable to give informed consent.'}, 'identificationModule': {'nctId': 'NCT00642057', 'acronym': 'TBZ', 'briefTitle': 'Compassionate Use of Tetrabenazine in the Treatment of Abnormal Movements', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Compassionate Use of Tetrabenazine in the Treatment of Hyperkinesias', 'orgStudyIdInfo': {'id': 'H-721'}}, 'armsInterventionsModule': {'interventions': [{'name': 'tetrabenazine', 'type': 'DRUG', 'description': '25 mg titrated to optimal dose per patient'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joseph Jankovic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, Neurology-PDCMDC', 'investigatorFullName': 'Joseph Jankovic', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}