Clinical trial NCT03686163: Effects of Intranasal Nerve Growth Factor for Acute Ischemic Stroke
Official title: Effects of Intranasal Nerve Growth Factor for Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Ischemic Stroke
Keywords: Acute Ischemic stroke
Nerve Growth Factor
Intranasal
Neurological Function
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: a favorable neurological function
timeFrame: at 90 days post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Neurology, Jinling Hospital
state: Jiangsu
Study officials:
affiliation: Department of Neurology, Jinling Hospital, China
name: Xinfeng Liu, MD
role: STUDY_CHAIR
References: