Recent Updates
Recently added Catalysts

Ethyl-EPA

Phase 3

Huntington Disease | Small molecule | Neurology |Amarin Corporation plc|Last Updated: Dec 27, 2007

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment300

FDA Designations

No designations recorded

Clinical trial landscape

Ethyl-EPA · 1 trial · 1 indication

Phase 3 1
NCT00146211TREND-HD - A Trial of Ethyl-EPA (Miraxion™) in Treating Mild to Moderate Huntington's DiseaseHuntington Disease
COMPLETED300 Analytics
PHASE3COMPLETED
TREND-HD - A Trial of Ethyl-EPA (Miraxion™) in Treating Mild to Moderate Huntington's Disease
Huntington DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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.
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Ethyl-EPA (Miraxion™)DRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range35 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites41

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 le...

Countries:United StatesCanada
Unlock Eligibility Criteria

Competitive Landscape -Huntington's Disease 8 trials (matched to "Huntington Disease")

Frequently asked questions about Ethyl-EPA

What is Ethyl-EPA used for in Huntington Disease?

Ethyl-EPA is an investigational small molecule being studied for the treatment of Huntington Disease. It was evaluated in the TREND-HD clinical trial, which enrolled 300 patients with mild to moderate Huntington Disease. The trial was a Phase 3, randomized, double-blind study conducted in the United States and Canada.

Who makes Ethyl-EPA?

Ethyl-EPA is being developed by Amarin Corporation plc, a biopharmaceutical company listed on the stock exchange under the ticker AMRN. The company sponsored the Phase 3 clinical trial of Ethyl-EPA for Huntington Disease.

What phase is Ethyl-EPA in?

Ethyl-EPA has completed a Phase 3 clinical trial for Huntington Disease. The trial, known as TREND-HD, was a randomized, double-blind study that enrolled 300 participants. As an investigational drug, Ethyl-EPA is still in clinical development and has not been approved by regulatory authorities.

What clinical trials is Ethyl-EPA in?

Ethyl-EPA was studied in the TREND-HD trial, registered as NCT00146211. This Phase 3 trial evaluated Ethyl-EPA in treating mild to moderate Huntington Disease. The study enrolled 300 participants aged 35 years and older in the United States and Canada, and it has been completed.

Is Ethyl-EPA the same as Miraxion?

Yes, Ethyl-EPA is also known as Miraxion. The Phase 3 clinical trial for Huntington Disease, TREND-HD, was titled 'A Trial of Ethyl-EPA (Miraxion™) in Treating Mild to Moderate Huntington's Disease.' This alternative name may be used in clinical and research contexts.