Effects of Intranasal Nerve Growth Factor for Acute Ischemic Stroke

Phase 4

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: Nerve Growth Factors; Drug: normal saline

• Registration Number: NCT03686163
• Lead Sponsor: Jinling Hospital, China

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.

Detailed Description

The proposed study is a randomized, double-blind, placebo-controlled trail of NGF, starting between 24 to 72 hours post acute ischemic stroke, continuing for 2 weeks.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2018-09-25
• Study First Submitted QC: 2018-09-25
• Study First Posted: 2018-09-26
• Primary Completion: 2019-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-29
• Last Update Posted: 2021-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IN-NGF group	Nerve Growth Factors	Patients who underwent acute ischemic stroke will be chosen to receive NGF randomly
Control group	normal saline	Patients who underwent acute ischemic stroke will be chosen to receive normal saline randomly

Primary Outcome Measures

Name	Time	Method
a favorable neurological function	at 90 days post-treatment	The primary outcome is determined as a favorable neurological function which is defined as Modified Rankin Scale(mRS) score of 0-3

Trial Locations

Locations (1)

Department of Neurology, Jinling Hospital; 🇨🇳 Nanjing, Jiangsu, China