Huntington DiseasePhase 3NCT00146211
TREND-HD - A Trial of Ethyl-EPA (Miraxion™) in Treating Mild to Moderate Huntington's Disease
A Phase 3 study testing Ethyl-EPA (Miraxion™) in people with Huntington Disease, run by Amarin Neuroscience Ltd at 41 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Huntington Disease
- What is being tested?
- Ethyl-EPA (Miraxion™)
- How many people
- 300 participants
- Where
- 41 sitesin 2 countries
- Study dates
- Sep 2005to Jul 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
41 sites in 2 countries.
41 sites in 2 countries
United States35 sites
Albany Medical College
Albany, New York
University of Michigan
Ann Arbor, Michigan
Emory University
Atlanta, Georgia
Medical College of Georgia
Augusta, Georgia
Johns Hopkins University
Baltimore, Maryland
University of Alabama at Birmingham
Birmingham, Alabama
Boston University
Boston, Massachusetts
Massachusetts General Hospital
Charlestown, Massachusetts
University of Virginia
Charlottesville, Virginia
Rush University Medical Center
Chicago, Illinois
University of Chicago
Chicago, Illinois
Ohio State University Parkinson's Center
Columbus, Ohio
Colorado Neurological Institute
Englewood, Colorado
University of Florida
Gainesville, Florida
Penn State Milton & Hershey Medical College
Hershey, Pennsylvania
Baylor College of Medicine
Houston, Texas
Indiana University
Indianapolis, Indiana
University of Iowa
Iowa City, Iowa
University of Kansas
Kansas City, Kansas
University of California San Diego
La Jolla, California
UCLA Medical Center
Los Angeles, California
North Shore-LIJ Health System
Manhasset, New York
University of Tennessee-Memphis
Memphis, Tennessee
University of Miami
Miami, Florida
Institute of Neurodegenerative Disorders
New Haven, Connecticut
Columbia University Medical Center
New York, New York
University of Pennsylvania
Philadelphia, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania
University of Rochester
Rochester, New York
University of California Davis
Sacramento, California
University of California San Francisco
San Francisco, California
Mayo Clinic Arizona
Scottsdale, Arizona
Washington University School of Medicine
St Louis, Missouri
University of South Florida
Tampa, Florida
Hereditary Neurological Disease Centre
Wichita, Kansas
Canada6 sites
University of Calgary
Calgary, Alberta
University of Alberta Glenrose Rehab Hospital
Edmonton, Alberta
University of British Columbia
London, Ontario
The Centre for Addiction and Mental Health
Markham, Ontario
Hotel-Dieu Hospital-CHUM
Montreal, Quebec
University of British Columbia
Vancouver, British Columbia
About this 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
This study is designed to determine the effect of 2 gram/day of ethyl-EPA on motor (movement) signs and symptoms of Huntington disease.
Read the 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.
- Conditions
- Huntington Disease
- Being tested
- Ethyl-EPA (Miraxion™)
- Keywords
- Trial, ethyl-EPA, Miraxion™, treating, mild, moderate, Huntington's
- Medical subject headings
- Huntington Disease, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethyl-EPA (Miraxion™)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionAug 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amarin Neuroscience Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Huntington Study Group
- Investigators
- Ira Shoulson, MD, Principal investigator, Huntington Study Group/University of RochesterChristopher Ross, MD, PhD, Principal investigator, Huntington Study Group/Johns Hopkins University School of MedicineBlair Leavitt, MD, Principal investigator, Huntington Study Group/University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00146211
- Sponsor's protocol ID
- AN01.01.0011
- Status last verified
- Dec 2007
- First submitted
- 2 Sep 2005
- Last updated
- 27 Dec 2007
- Results posted
- No
Publications
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.
PubMed 19064745
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00146211
- Acronym / sponsor ID
- AN01.01.0011
- Conditions
- Huntington Disease
- Keywords
- Trial, ethyl-EPA, Miraxion™, treating, mild, moderate, Huntington's
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Amarin Neuroscience LtdIndustry (pharma, biotech, devices)
- Collaborators
- Huntington Study Group
- Study start
- Sep 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 7 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to determine the effect of 2 gram/day of ethyl-EPA on motor (movement) signs and symptoms of Huntington disease.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ethyl-EPA (Miraxion™) | Drug | – |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2007.
- Derived from this study: PubMed 19064745Huntington 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ira Shoulson, MD principal investigator
Huntington Study Group/University of Rochester
Christopher Ross, MD, PhD principal investigator
Huntington Study Group/Johns Hopkins University School of Medicine
Blair Leavitt, MD principal investigator
Huntington Study Group/University of British Columbia
41 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ethyl-EPA (Miraxion™) in people with Huntington Disease, run by Amarin Neuroscience Ltd at 41 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00146211, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2007.