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Riluzole

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment537

FDA Designations

No designations recorded

Clinical trial landscape

Riluzole · 1 trial · 1 indication

Phase 3 1
NCT00277602Riluzole in Huntington's DiseaseHuntington Disease
COMPLETED537 Analytics
PHASE3COMPLETED
Riluzole in Huntington's Disease
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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 to 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 8 trials (matched to "Huntington Disease")

Frequently asked questions about Riluzole

What is Riluzole used for in Huntington Disease?

Riluzole is a small molecule being studied for the treatment of Huntington Disease. It is currently in Phase 3 clinical development as an investigational therapy. The drug has been evaluated in a completed Phase 3 trial with 537 participants, though it is not yet approved for this condition.

Who makes Riluzole?

Riluzole is being developed by Sanofi, a global biopharmaceutical company traded on the stock exchange under the ticker SNY. Sanofi is conducting clinical research to evaluate the drug's potential in treating Huntington Disease.

What phase is Riluzole in?

Riluzole is in Phase 3 clinical development for Huntington Disease. It has completed one Phase 3 trial, which enrolled 537 participants. The drug remains investigational and has not been approved for this indication.

What clinical trials is Riluzole in?

Riluzole has been studied in a completed Phase 3 clinical trial identified as NCT00277602, titled "Riluzole in Huntington's Disease." This trial enrolled 537 participants with Huntington Disease and was a randomized, double-blind study.

Is Riluzole FDA approved?

Riluzole is not FDA approved for Huntington Disease. It is an investigational drug currently in Phase 3 clinical development. The completed Phase 3 trial, NCT00277602, evaluated the drug in 537 participants, but approval status has not been established.