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Effects of Intranasal Nerve Growth Factor for Traumatic Brain Injury

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01212679
First Posted: October 1, 2010
Last Update Posted: November 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Xinfeng Liu, Jinling Hospital, China
  Purpose
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.

Condition Intervention Phase
Traumatic Brain Injury Drug: nerve growth factor Drug: nomral saline Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of Intranasal Nerve Growth Factor for Traumatic Brain Injury(TBI)

Resource links provided by NLM:


Further study details as provided by Xinfeng Liu, Jinling Hospital, China:

Primary Outcome Measures:
  • improved neurological functions [ Time Frame: 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:
  • HAMA,HAMD [ Time Frame: at months 6 post-treatment ]
    HAMA(Hamilton Anxiety Scale ),HAMD(Hamilton Depression Scale).


Enrollment: 106
Study Start Date: December 2010
Study Completion Date: October 2017
Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nerve growth factor
Patients who underwent TBI will be chosen to receive NGF randomly.
Drug: nerve growth factor
The experimental group patients will receive NGF 20ug/d intranasally for 2 weeks.
Placebo Comparator: Control
Patients who underwent TBI will be chosen to receive nomral saline randomly.
Drug: nomral saline
The Placebo Comparator group patients will receive nomral saline 20ug/d intranasally for 2 weeks.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01212679


Locations
China, Jiangsu
Department of Neurology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, China, 210002
Sponsors and Collaborators
Jinling Hospital, China
Investigators
Study Chair: Xinfeng Liu, MD Department of Neurology, Jinling Hospital, Nanjing University School of Medicine
  More Information

Responsible Party: Xinfeng Liu, Professor, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT01212679     History of Changes
Other Study ID Numbers: NGF-TBI
First Submitted: September 30, 2010
First Posted: October 1, 2010
Last Update Posted: November 1, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Xinfeng Liu, Jinling Hospital, China:
nerve growth factor
traumatic brain injury
intranasal
prognosis
neurological function

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action