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Ethyl-EPA

Phase 3

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment300
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00146211TREND-HD - A Trial of Ethyl-EPA (Miraxion™) in Treating Mild to Moderate Huntington's DiseasePHASE3 COMPLETED 300Sep 1, 2005Jul 1, 2007Dec 27, 200741 United States, Canada
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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 — 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 9 trials