NCT01212679

Effects of Intranasal Nerve Growth Factor for Traumatic Brain Injury

Pilot Study of Intranasal Nerve Growth Factor for Traumatic Brain Injury(TBI)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Jinling Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Traumatic bain injury(TBI) remains a hidden epidemic involving individuals affected predominantly at a young age who in the most severe cases remain with permanent physical,psychological and cognitive deficits.This study will investigate the therapeutic effects of intranasal Nerve Growth Factor(NGF) in TBI.

Detailed description

Early NGF concentration in the cerebral spinal fluid(CSF)correlates significantly with the severity of head injury, and NGF upregulation correlates with better neurologic outcomes and could be useful to obtain clinical and prognostic information in patients with serve TBI. However, the clinical use of NGF is difficulty associated with delivering them to the CNS because of the existing of blood-brain barrier(BBB). Intranasal delivery drug is a noninvasive and convenient novel method bypassing BBB, which results in targeting therapeutics to the CNS rapidly. The proposed study is a randomized, double-blind, placebo-controlled trail of NGF, starting between 24 to 72 hours post TBI, continuing for 2 weeks.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
DRUG	nerve growth factor	The experimental group patients will receive NGF 20ug/d intranasally for 2 weeks.
DRUG	nomral saline	The Placebo Comparator group patients will receive nomral saline 20ug/d intranasally for 2 weeks.

Timeline

• Start date: 2010-12-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2010-10-01
• Last updated: 2017-11-01

Locations

1 site across 1 country: China