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Effects of Intranasal Nerve Growth Factor for Traumatic Brain Injury

NCT ID: NCT01212679

Last Updated: 2017-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2017-10-31

Brief Summary

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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

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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

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Traumatic Brain Injury

Keywords

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nerve growth factor traumatic brain injury intranasal prognosis neurological function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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nerve growth factor

Patients who underwent TBI will be chosen to receive NGF randomly.

Group Type EXPERIMENTAL

nerve growth factor

Intervention Type DRUG

The experimental group patients will receive NGF 20ug/d intranasally for 2 weeks.

Control

Patients who underwent TBI will be chosen to receive nomral saline randomly.

Group Type PLACEBO_COMPARATOR

nomral saline

Intervention Type DRUG

The Placebo Comparator group patients will receive nomral saline 20ug/d intranasally for 2 weeks.

Interventions

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nerve growth factor

The experimental group patients will receive NGF 20ug/d intranasally for 2 weeks.

Intervention Type DRUG

nomral saline

The Placebo Comparator group patients will receive nomral saline 20ug/d intranasally for 2 weeks.

Intervention Type DRUG

Eligibility Criteria

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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.

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Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jinling Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Xinfeng Liu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xinfeng Liu, MD

Role: STUDY_CHAIR

Department of Neurology, Jinling Hospital, Nanjing University School of Medicine

Locations

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Department of Neurology, Jinling Hospital, Nanjing University School of Medicine

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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NGF-TBI

Identifier Type: -

Identifier Source: org_study_id