Effects of Intranasal Nerve Growth Factor for Traumatic Brain Injury

Phase 2

Completed

• Conditions: Traumatic Brain Injury
• Interventions: Drug: nomral saline; Drug: nerve growth factor

• Registration Number: NCT01212679
• Lead Sponsor: Jinling Hospital, China

Brief 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.

Study Timeline

• Study First Submitted: 2010-09-30
• Study First Submitted QC: 2010-09-30
• Study First Posted: 2010-10-01
• Study Start: 2010-12
• Status Verified: 2016-11
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Last Update Submitted: 2017-10-30
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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 the subject's behalf.

Exclusion Criteria

Skull fracture, Cerebrospinal fluid rhinorrhea. Severe concurrent illness with life expectancy<6 months or other serious illness which have a major impact on the outcome.

Treatment with other investigational agents in the past 4 weeks. Allergy to NGF. Primary ciliary dyskinesia, Asthma, Cystic fibrosis, Viral and bacterial infections, Diabetes mellitus.

Inability to provide informed consent. Pregnancy or breast-breeding. Women of childbearing age will be given a pregnancy test during screening to exclude pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control	nomral saline	Patients who underwent TBI will be chosen to receive nomral saline randomly.
nerve growth factor	nerve growth factor	Patients who underwent TBI will be chosen to receive NGF randomly.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
HAMA,HAMD	at months 6 post-treatment	HAMA(Hamilton Anxiety Scale ),HAMD(Hamilton Depression Scale).

Trial Locations

Locations (1)

Department of Neurology, Jinling Hospital, Nanjing University School of Medicine; 🇨🇳 Nanjing, Jiangsu, China