Effects of Intranasal Nerve Growth Factor for Acute Ischemic Stroke

NCT ID: NCT03686163

Last Updated: 2021-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2020-12-31

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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

IN-NGF group

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

Group Type: EXPERIMENTAL

Nerve Growth Factors

Intervention Type: DRUG

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

Control group

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

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: DRUG

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

Interventions

Nerve Growth Factors

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

Intervention Type: DRUG

normal saline

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jinling Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Xinfeng Liu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xinfeng Liu, MD

Role: STUDY_CHAIR

Department of Neurology, Jinling Hospital, China

Locations

Department of Neurology, Jinling Hospital

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

NGF-ischemic stroke

Identifier Type: -

Identifier Source: org_study_id