Effects of Intranasal Nerve Growth Factor for Acute Ischemic Stroke

NCT03686163 | Completed Phase 4

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

Brief Summary

Stroke remains one of the leading causes of death and adult disability worldwide. Yet, currently, the only accepted treatment for acute ischemic stroke(AIS) is recanalization of occluded arteries. Thrombolysis with tissue plasminogen activator, limited by its narrow therapeutic time window and the concern of hemorrhagic complication, is still uncommon in use. The other approach is to try to impede the ischemic cascade by targeting various components of the cascade that are deemed to be of importance, namely, a neuroprotection strategy. Nerve growth factor (NGF) plays extensive roles in preventing ischemic injury. Besides that, it is also involved in neurogenesis of the central nervous system (CNS). In addition, the levels of NGF protein and messenger RNA significantly decreased in the CNS at the first few hours and returned to normal levels several days later after middle cerebral artery occlusion (MCAO) in animal models. These observed results suggested that NGF was demanded in ischemic brain injury, but endogenous NGF is insufficient for the requirement and delivering exogenous ones will be blocked in entering into the CNS by the blood-brain barrier (BBB). Intracerebroventricular or intracerebral injection of NGF or grafting of NGF-producing cells may be less practicable due to invasiveness and safety concerns. Intranasal (IN) administration is a noninvasive and acceptable delivery strategy for drugs bypassing BBB and can deliver NGF to the CNS, which has been proved to show neuroprotective effects on brain injury. The effects of intranasal NGF in human ischemic stroke is still controversial that need further evaluation.

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic stroke; Nerve Growth Factor; Intranasal; Neurological Function

Outcome Measures

Primary Outcomes (1)

• a favorable neurological function

  The primary outcome is determined as a favorable neurological function which is defined as Modified Rankin Scale(mRS) score of 0-3

  at 90 days post-treatment

Study Arms (2)

IN-NGF group

EXPERIMENTAL

Patients who underwent acute ischemic stroke will be chosen to receive NGF randomly

Drug: Nerve Growth Factors

Control group

PLACEBO COMPARATOR

Patients who underwent acute ischemic stroke will be chosen to receive normal saline randomly

Drug: normal saline

Interventions

Nerve Growth Factors DRUG

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

IN-NGF group

normal saline DRUG

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

Control group

Eligibility Criteria

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

You may qualify if:

• Age ≥18years;
• Acute ischemic stroke consistent within 72 hours;
• Written informed consent from patient or surrogate, if unable to provide consent.

You may not qualify if:

• Premorbid mRS ≥ 3 points;
• Currently in pregnant or lactating;
• Allergy to NGF;
• Current participation in another investigation drug or device study;
• Life expectancy less than 1 year.

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

Department of Neurology, Jinling Hospital

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Ischemic Stroke; Hereditary Sensory and Autonomic Neuropathies

Interventions

Nerve Growth Factors; Saline Solution

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; 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)

Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Nerve Tissue Proteins; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Xinfeng Liu, MD

  Department of Neurology, Jinling Hospital, China

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: September 26, 2018
• Study Start: January 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)