Overview

This trial is active, not recruiting.

Condition traumatic brain injury
Treatments nerve growth factor, nomral saline
Phase phase 2
Sponsor Jinling Hospital, China
Start date December 2010
End date December 2016
Trial size 118 participants
Trial identifier NCT01212679, NGF-TBI

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Patients who underwent TBI will be chosen to receive NGF randomly.
nerve growth factor GM1
The experimental group patients will receive NGF 20ug/d intranasally for 2 weeks.
(Placebo Comparator)
Patients who underwent TBI will be chosen to receive nomral saline randomly.
nomral saline
The Placebo Comparator group patients will receive nomral saline 20ug/d intranasally for 2 weeks.

Primary Outcomes

Measure
improved neurological functions
time frame: at months 6 post-treatment

Secondary Outcomes

Measure
HAMA,HAMD
time frame: at months 6 post-treatment

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title Pilot Study of Intranasal Nerve Growth Factor for Traumatic Brain Injury(TBI)
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Jinling Hospital, China.