Effects of Intranasal Nerve Growth Factor for Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

Official title:

Effects of Intranasal Nerve Growth Factor for Acute Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03686163
• Other study ID #: NGF-ischemic stroke
• Status: Completed
• Phase: Phase 4
• Start date: January 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2021
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Stroke

Intervention

Drug:
• Nerve Growth Factors
the experimental group patients will receive NGF 20ug/d intranasally for 2 weeks
• normal saline
The Placebo Comparator group patients will receive nomral saline 20ug/d intranasally for 2 weeks

Locations

Country	Name	City	State
China	Department of Neurology, Jinling Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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