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Sponsors and Collaborators: |
Amarin Neuroscience Ltd Huntington Study Group |
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Information provided by: | Amarin Neuroscience Ltd |
ClinicalTrials.gov Identifier: | NCT00146211 |
This study is designed to determine the effect of 2 gram/day of ethyl-EPA on motor (movement) signs and symptoms of Huntington disease.
Condition | Intervention | Phase |
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Huntington Disease |
Drug: Ethyl-EPA (Miraxion™) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Multicenter, Double Blind, Randomized, Parallel Group, Placebo-Controlled Trial of Ethyl-EPA (Miraxion™) in Subjects With Mild to Moderate Huntington's Disease |
Enrollment: | 300 |
Study Start Date: | September 2005 |
Study Completion Date: | July 2007 |
Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Multi-center, double blind, placebo-controlled study with parallel groups of outpatients with early, symptomatic Huntington's disease. Participants will be randomized to receive 1 gram twice daily (2 gram/day total daily dose) of active study drug or placebo. The 6-month placebo-controlled phased will be followed by a subsequent 6-month open-label extension phase with all subjects receiving 1 gram twice daily (2 grams/day total daily dose) of active study drug.
Ages Eligible for Study: | 35 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Ira Shoulson, MD | Huntington Study Group/University of Rochester |
Principal Investigator: | Christopher Ross, MD, PhD | Huntington Study Group/Johns Hopkins University School of Medicine |
Principal Investigator: | Blair Leavitt, MD | Huntington Study Group/University of British Columbia |
Responsible Party: | University of Rochester ( Ira Shoulson, MD/Principal Investigator ) |
Study ID Numbers: | AN01.01.0011 |
Study First Received: | September 2, 2005 |
Last Updated: | December 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00146211 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Trial ethyl-EPA Miraxion™ treating |
mild moderate Huntington's |
Ganglion Cysts Huntington disease Basal Ganglia Diseases Central Nervous System Diseases 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 |
Nervous System Diseases |