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Sponsored by: |
FDA Office of Orphan Products Development |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00029874 |
This is a study to determine whether treatment with minocycline is safe and tolerable in patients with Huntington's disease (HD) and whether minocycline reduces symptoms of HD in these patients.
Condition | Intervention | Phase |
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Huntington's Disease |
Drug: Minocycline |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study |
Official Title: | Minocycline Dosing and Safety in Huntington's Disease |
Estimated Enrollment: | 63 |
Study Start Date: | September 2001 |
Estimated Study Completion Date: | August 2003 |
Huntington's disease (HD) is a dominantly inherited disorder. It is uniformly progressive and there is no known effective treatment or cure. The pathogenesis is largely unknown; however, recent studies implicate caspase activation, glutamate excitotoxicity, and free radical toxicity as possible causes of HD. Pharmacological agents that block these pathways may be therapeutic in HD. Minocycline is an antibiotic that also inhibits caspase-1 and caspase-3 expression, and inducible nitric oxide synthetase activity, which are factors that may play an important role in the mechanisms of neuropathology in HD.
Two dosages of minocycline or placebo will be given to ambulatory patients with HD over an 8-week period and the tolerability will be compared. Additional measures of safety and the change in motor, behavior, cognitive, and function features will be examined.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Study ID Numbers: | FD-R-1968-01 |
Study First Received: | January 24, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00029874 |
Health Authority: | United States: Food and Drug Administration |
Tetracyclines Dose-Response Relationship, Drug |
Minocycline Ganglion Cysts Huntington disease Basal Ganglia Diseases Central Nervous System Diseases Tetracycline Brain Diseases Neurodegenerative Diseases Dyskinesias Cognition Disorders |
Chorea Delirium, Dementia, Amnestic, Cognitive Disorders Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn Mental Disorders Movement Disorders Dementia Huntington Disease Delirium |
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Nervous System Diseases Pharmacologic Actions |