Text Size

TREND-HD - A Trial of Ethyl-EPA (Miraxion™) in Treating Mild to Moderate Huntington's Disease

This study has been completed.
Sponsor:
Collaborator:
Huntington Study Group
Information provided by:
Amarin Neuroscience Ltd
ClinicalTrials.gov Identifier:
NCT00146211
First received: September 2, 2005
Last updated: December 24, 2007
Last verified: December 2007
History of Changes
  Purpose

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
Huntington Disease
 Drug: Ethyl-EPA (Miraxion™)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Amarin Neuroscience Ltd:

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.

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)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00146211

  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
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided by Amarin Neuroscience Ltd

Additional 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     History of Changes
Other Study ID Numbers: AN01.01.0011
Study First Received: September 2, 2005
Last Updated: December 24, 2007
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Amarin Neuroscience Ltd:
Trial
ethyl-EPA
Miraxion™
treating
 mild
moderate
Huntington's

Additional relevant MeSH terms:
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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013