Effects of Intranasal Nerve Growth Factor for Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01212679
• Other study ID #: NGF-TBI
• Status: Completed
• Phase: Phase 2
• First received: September 30, 2010
• Last updated: October 30, 2017
• Start date: December 2010
• Est. completion date: October 2017

Study information

• Verified date: November 2016
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Drug:
• nerve growth factor
The experimental group patients will receive NGF 20ug/d intranasally for 2 weeks.
• nomral saline
The Placebo Comparator group patients will receive nomral saline 20ug/d intranasally for 2 weeks.

Locations

Country	Name	City	State
China	Department of Neurology, Jinling Hospital, Nanjing University School of Medicine	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improved neurological functions	Neurological functions will be assessed by GOS(Glasgow Outcome Scale), mRS(modified Rankin Scale),BI(Barthel index).	at months 6 post-treatment
Secondary	HAMA,HAMD	HAMA(Hamilton Anxiety Scale ),HAMD(Hamilton Depression Scale).	at months 6 post-treatment