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Ethyl-EPA

Phase 3

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

Ethyl-EPA target and mechanism

ModalitySmall molecule

Also known as Ethyl-EPA (Miraxion™)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment300

FDA Designations

No designations recorded

Ethyl-EPA clinical trials

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
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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.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Ethyl-EPA (Miraxion™)DRUG -
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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
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Competitive Landscape -Huntington's Disease 15 trials (matched to "Huntington Disease")

Frequently asked questions about Ethyl-EPA

What is Ethyl-EPA used for?

Ethyl-EPA is an investigational small molecule being studied for the treatment of mild to moderate Huntington Disease, a progressive neurological disorder. It has been evaluated in a Phase 3 clinical trial called TREND-HD. Ethyl-EPA is not approved for any indication and remains in clinical development.

Who is developing Ethyl-EPA?

Ethyl-EPA is being developed by Amarin Corporation plc, a biopharmaceutical company whose ticker symbol is AMRN. Amarin sponsored the Phase 3 TREND-HD trial of Ethyl-EPA in Huntington Disease.

What phase is Ethyl-EPA in?

Ethyl-EPA is in Phase 3 development for Huntington Disease. The only listed trial, TREND-HD, is a completed Phase 3 study. Ethyl-EPA is investigational and has not been approved by the FDA for any use.

What clinical trials is Ethyl-EPA in?

Ethyl-EPA has been studied in one clinical trial: NCT00146211, also known as TREND-HD. This completed Phase 3 trial enrolled 300 participants with mild to moderate Huntington Disease across the United States and Canada. It was randomized and double-blind, with participants aged 35 years and older.

Is Ethyl-EPA the same as Miraxion?

Yes, Ethyl-EPA is also known as Miraxion. Miraxion is a brand name used for Ethyl-EPA, the investigational small molecule developed by Amarin Corporation plc for Huntington Disease. Both names refer to the same drug candidate.