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nerve growth factor

Phase 2

Traumatic Brain Injury | Small molecule | Other |China Pharma Holdings, Inc.|Last Updated: Nov 1, 2017

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-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment106
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01212679Effects of Intranasal Nerve Growth Factor for Traumatic Brain InjuryPHASE2 COMPLETED 106Dec 1, 2010Oct 1, 2017Nov 1, 20171 China
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Study Endpoints
Primary Endpoints
improved neurological functions
at months 6 post-treatment

Neurological functions will be assessed by GOS(Glasgow Outcome Scale), mRS(modified Rankin Scale),BI(Barthel index).

Secondary Endpoints
HAMA,HAMD
at months 6 post-treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
nerve growth factorEXPERIMENTALPatients who underwent TBI will be chosen to receive NGF randomly.
ControlPLACEBO_COMPARATORPatients who underwent TBI will be chosen to receive nomral saline randomly.
Interventions
NameTypeDescription
nerve growth factorDRUGThe experimental group patients will receive NGF 20ug/d intranasally for 2 weeks.
nomral salineDRUGThe Placebo Comparator group patients will receive nomral saline 20ug/d intranasally for 2 weeks.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Moderate to severe blunt traumatic brain injury defined as Glasgow Coma Scale(GCS) between 7 and 13. Age 18\~65 years. Admission to Jinling Hospital between 24 to 72 hours. Subjects capable of giving informed consent or have an acceptable surrogate capable of giving consent on ...

Countries:China
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