Trial record 1 of 2 for:
amarin AND huntington
TREND-HD - A Trial of Ethyl-EPA (Miraxion™) in Treating Mild to Moderate Huntington's Disease
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00146211 |
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Recruitment Status :
Completed
First Posted : September 7, 2005
Last Update Posted : December 27, 2007
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Sponsor:
Amarin Neuroscience Ltd
Collaborator:
Huntington Study Group
Information provided by:
Amarin Neuroscience Ltd
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Huntington Disease | Drug: Ethyl-EPA (Miraxion™) | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 300 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | September 2005 |
| Actual Primary Completion Date : | August 2007 |
| Actual Study Completion Date : | July 2007 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Huntington disease
MedlinePlus related topics:
Huntington's Disease
Drug Information available for:
Icosapent
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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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| Ages Eligible for Study: | 35 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Clinical features of Huntington's disease (HD) and confirmatory family history of HD, and/or CAG repeat expansion greater than or equal to 36
- Ambulatory, not requiring skilled nursing care (total functional capacity [TFC] greater than or equal to 7)
- Chorea score of at least 2 in one extremity (UHDRS)
- Maximal dystonia less than or equal to 2 and maximal bradykinesia less than or equal to 2
- 35 years of age or older of either gender
- Must be on stable dosages of non-competitive NMDA receptor antagonists, and/or antiepileptic medications for 60 days prior to baseline
- Females of child-bearing potential must use adequate birth control
Exclusion Criteria:
- History of established diagnosis of tardive dyskinesia
- Clinical evidence of unstable medical or psychiatric illness
- Clinically significant active and unstable psychotic disease (hallucinations or delusions)
- Major depression (Beck Depression Inventory [BDI]-II Score greater than 20) at Screening Visit
- Suicidal ideation (BDI-II item 9 greater than or equal to 2) at Screening Visit
- History of clinically significant substance abuse within 12 months of Baseline Visit
- Pregnant/lactating women
- Participation in other drug studies within 60 days prior to Baseline Visit
- Previous participation in any investigational study of ethyl-EPA (Miraxion™)
- Use of aspirin at daily dosage greater than 325 mg/day
- Exclusionary Drugs (within 6 months Baseline Visit): Depot neuroleptics
- Exclusionary Drugs (within 60 days Baseline Visit): Omega-3 supplementation, tetrabenazine or reserpine, high dose and/or variable dose oral anti-psychotic medications, steroid (other than topical), selenium supplements greater than 55 mcg/day, lithium, benzodiazepines (except for low dose), anticoagulants
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00146211
Locations
Show 41 study locations
Sponsors and Collaborators
Amarin Neuroscience Ltd
Huntington Study Group
Investigators
| 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 |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ira Shoulson, MD/Principal Investigator, University of Rochester |
| ClinicalTrials.gov Identifier: | NCT00146211 |
| Other Study ID Numbers: |
AN01.01.0011 |
| First Posted: | September 7, 2005 Key Record Dates |
| Last Update Posted: | December 27, 2007 |
| Last Verified: | December 2007 |
Keywords provided by Amarin Neuroscience Ltd:
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Trial ethyl-EPA Miraxion™ treating |
mild moderate Huntington's |
Additional relevant MeSH terms:
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Huntington Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Dementia Chorea Dyskinesias Movement Disorders |
Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Cognition Disorders Neurocognitive Disorders Mental Disorders Eicosapentaenoic acid ethyl ester Platelet Aggregation Inhibitors Lipid Regulating Agents |