| Safety and tolerability of the free-radical scavenger OPC-14117 in Huntington's disease. The Huntington Study Group. | |
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MedLine Citation:
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PMID: 9595988 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Oxidative damage due to free-radical generation in the setting of underlying defects of neuronal energy metabolism has been implicated as a pathogenetic mechanism for Huntington's disease (HD). The authors conducted a randomized, double-blind, placebo-controlled, multicenter trial of the tolerability of OPC-14117, a lipophilic free-radical scavenger that concentrates in the brain. Ambulatory patients with HD received OPC-14117 60 mg/d, 120 mg/d, 240 mg/d, or placebo and were assessed by the Unified Huntington's Disease Rating Scale (UHDRS) for 20 weeks, including 12 or 16 weeks of assigned treatment and 8 or 4 weeks of blinded withdrawal of the study drug. Tolerability was measured by the proportion of patients completing the initial 12-week course of treatment on their originally assigned regimen. Sixty-four patients were enrolled in the study, 56 of whom completed the 12 weeks of treatment. Treatment was discontinued in four patients (1 placebo, 1 60 mg/d, 2 240 mg/d) due to asymptomatic but persistent serum elevations of liver transaminase. Two patients (1 60 mg/d and 1 120 mg/d) withdrew because of increased involuntary movements, one patient (60 mg/d) withdrew due to persistent dry eyes, and one patient (120 mg/d) withdrew because of persistent vomiting. There were no significant differences between treatment arms in the primary measures of tolerability, the frequency and types of clinical adverse events, or the clinical/functional features of HD. OPC-14117 was safe and generally well tolerated; however, elevations of liver transaminase suggested that continued surveillance monitoring is warranted in conducting more long-term studies of this antioxidant therapy. |
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Authors:
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Publication Detail:
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Type: Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S. |
Journal Detail:
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Title: Neurology Volume: 50 ISSN: 0028-3878 ISO Abbreviation: Neurology Publication Date: 1998 May |
Date Detail:
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Created Date: 1998-06-08 Completed Date: 1998-06-08 Revised Date: 2007-11-14 |
Medline Journal Info:
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Nlm Unique ID: 0401060 Medline TA: Neurology Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 1366-73 Citation Subset: AIM; IM |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Dose-Response Relationship, Drug Double-Blind Method Female Free Radical Scavengers / adverse effects*, blood, cerebrospinal fluid Free Radicals Humans Huntington Disease / blood, cerebrospinal fluid, drug therapy* Hydroxyl Radical Indans / adverse effects*, blood, cerebrospinal fluid Lipid Peroxidation / drug effects* Male Middle Aged Nerve Tissue Proteins / metabolism* Oxidation-Reduction Piperazines / adverse effects*, blood, cerebrospinal fluid |
| Grant Support | |
ID/Acronym/Agency:
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RR00039/RR/NCRR NIH HHS; RR00044/RR/NCRR NIH HHS; RR00645/RR/NCRR NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Free Radical Scavengers; 0/Free Radicals; 0/Indans; 0/Nerve Tissue Proteins; 0/Piperazines; 103233-65-4/OPC 14117; 3352-57-6/Hydroxyl Radical |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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