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Riluzole

Phase 3

Huntington Disease | Small molecule | Rare Disease |Sanofi|Last Updated: Feb 17, 2012

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment537
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00277602Riluzole in Huntington's DiseasePHASE3 COMPLETED 537Nov 1, 1999Jul 1, 2004Feb 17, 2012 -
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Study Endpoints
Primary Endpoints
UHDRS-motor score, TFC
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
RiluzoleDRUG -
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Eligibility Criteria
Age Range25 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Clinical diagnosis of Huntington's disease and CAG repeat length of 36 or more * UHDRS Motor score of at least 5 points * UHDRS TFC score of at least 8 points, i.e. patients must be independently ambulatory and must not require nursing care * Females require a negative blood p...

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Competitive Landscape -Huntington's Disease 9 trials