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HP184

Phase 2

Spinal Cord Injury | Small molecule | Other |Sanofi|Last Updated: Aug 21, 2008

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 Enrollment262
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00093275HP184 in Chronic Spinal Cord Injury SubjectsPHASE2 COMPLETED 262Oct 1, 2004Dec 1, 2005Aug 21, 20085 United States, Australia +3
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Study Endpoints
Primary Endpoints
Change from baseline in total motor score of American Spinal Injury Association (ASIA) manual motor test at Week 24.
Secondary Endpoints
Safety evaluation.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
HP184DRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Male and female subjects with incomplete (traumatic), chronic (defined as 18 months or more post spinal cord injury) SCI aged 18 to 65 years * CSCI must be categorized in classes C or D in the ASIA impairment scale. (C = Incomplete impairment with motor function preserved belo...

Countries:United StatesAustraliaGermanyIndiaUnited Kingdom
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