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| Name | Class |
|---|---|
| Huntington Study Group | NETWORK |
This study is designed to determine the effect of 2 gram/day of ethyl-EPA on motor (movement) signs and symptoms of Huntington disease.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethyl-EPA (Miraxionâ„¢) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To compare with placebo the effect of ethyl-EPA on the Total Motor Score-4 component (TMS) of the Unified Huntington's Disease Rating Scale (UHDRS) over a 6-month period of observation. |
| Measure | Description | Time Frame |
|---|---|---|
| To compare with placebo the effect of ethyl-EPA over a 6-month period of observation on, 1) Chorea (UHDRS Total Motor Score Scale); 2) Total Motor Score component (TMS) of the UHDRS; and, 3) Clinical Global Impression (CGI) score. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | United States | |||
| Mayo Clinic Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19064745 | Derived | Huntington Study Group TREND-HD Investigators. Randomized controlled trial of ethyl-eicosapentaenoic acid in Huntington disease: the TREND-HD study. Arch Neurol. 2008 Dec;65(12):1582-9. doi: 10.1001/archneur.65.12.1582. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Scottsdale |
| Arizona |
| United States |
| University of California San Diego | La Jolla | California | United States |
| UCLA Medical Center | Los Angeles | California | United States |
| University of California Davis | Sacramento | California | United States |
| University of California San Francisco | San Francisco | California | United States |
| Colorado Neurological Institute | Englewood | Colorado | United States |
| Institute of Neurodegenerative Disorders | New Haven | Connecticut | United States |
| University of Florida | Gainesville | Florida | United States |
| University of Miami | Miami | Florida | United States |
| University of South Florida | Tampa | Florida | United States |
| Emory University | Atlanta | Georgia | United States |
| Medical College of Georgia | Augusta | Georgia | United States |
| Rush University Medical Center | Chicago | Illinois | United States |
| University of Chicago | Chicago | Illinois | United States |
| Indiana University | Indianapolis | Indiana | United States |
| University of Iowa | Iowa City | Iowa | United States |
| University of Kansas | Kansas City | Kansas | United States |
| Hereditary Neurological Disease Centre | Wichita | Kansas | United States |
| Johns Hopkins University | Baltimore | Maryland | United States |
| Boston University | Boston | Massachusetts | United States |
| Massachusetts General Hospital | Charlestown | Massachusetts | United States |
| University of Michigan | Ann Arbor | Michigan | United States |
| Washington University School of Medicine | St Louis | Missouri | United States |
| Albany Medical College | Albany | New York | United States |
| North Shore-LIJ Health System | Manhasset | New York | United States |
| Columbia University Medical Center | New York | New York | United States |
| University of Rochester | Rochester | New York | United States |
| Ohio State University Parkinson's Center | Columbus | Ohio | United States |
| Penn State Milton & Hershey Medical College | Hershey | Pennsylvania | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | United States |
| University of Tennessee-Memphis | Memphis | Tennessee | United States |
| Baylor College of Medicine | Houston | Texas | United States |
| University of Virginia | Charlottesville | Virginia | United States |
| University of Calgary | Calgary | Alberta | Canada |
| University of Alberta Glenrose Rehab Hospital | Edmonton | Alberta | Canada |
| University of British Columbia | Vancouver | British Columbia | Canada |
| University of British Columbia | London | Ontario | Canada |
| The Centre for Addiction and Mental Health | Markham | Ontario | Canada |
| Hotel-Dieu Hospital-CHUM | Montreal | Quebec | Canada |
| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C035276 | eicosapentaenoic acid ethyl ester |
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
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