Effects of Intranasal Nerve Growth Factor for Traumatic Brain Injury

NCT01212679 | Completed Phase 2 DMC

• 1 other identifier: NGF-TBI
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

nerve growth factor; traumatic brain injury; intranasal; prognosis; neurological function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• HAMA,HAMD

  at months 6 post-treatment

Study Arms (2)

nerve growth factor

EXPERIMENTAL

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

Drug: nerve growth factor

Control

PLACEBO COMPARATOR

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

Drug: nomral saline

Interventions

nerve growth factor DRUG

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

nerve growth factor

nomral saline DRUG

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

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Hereditary Sensory and Autonomic Neuropathies

Interventions

Nerve Growth Factor

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Nervous System Malformations; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Nerve Growth Factors; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Nerve Tissue Proteins; Biological Factors

Study Officials

• Xinfeng Liu, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 1, 2010
• Study Start: December 1, 2010
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 1, 2017

Record last verified: 2016-11

Locations

CN (1)