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Cethrin

Phase 1

Spinal Cord Injury | Small molecule | Other |Vertex Pharmaceuticals Incorporated|Last Updated: Apr 14, 2016

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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00500812A Safety Study for Cethrin (BA-210) in the Treatment of Acute Thoracic and Cervical Spinal Cord InjuriesPHASE1 COMPLETED 48 — — Feb 1, 2005Feb 1, 2009Apr 14, 20168 United States, Canada
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Study Endpoints
Primary Endpoints
The primary goal of this study is to determine the safety and tolerability of Cethrin when administered in conjunction with fibrin sealant to the dura mater of the spinal cord.
Prestudy, 24-72 hrs, 6 weeks, 3, 6 & 12 months
Secondary Endpoints
Efficacy by AIS
Pre-study, 24-72 hrs, 6 weeks, 3, 6 & 12 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
0.3 mgEXPERIMENTALSubjects Receiving 0.3 mg Cethrin
1 mgEXPERIMENTALSubjects receiving 1 mg Cethrin
3 mgEXPERIMENTALSubjects receiving 3 mg Cethrin
6 mgEXPERIMENTALSubjects receiving 6 mg Cethrin
9 mgEXPERIMENTALSubjects receiving 9 mg Cethrin
Interventions
NameTypeDescription
CethrinDRUG -
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Eligibility Criteria
Age Range16 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: Patients will be enrolled in this study only if they meet all of the following criteria: * Informed Consent Form signed by the patient or patient's legal representative. * Male or female, aged 16-70 years, inclusive. * For Group 1, patients with acute thoracic (T2-T12) spinal c...

Countries:United StatesCanada
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