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RECRUITING
NCT07205328
PHASE2

A Clinical Trial of MT200605 for the Treatment of Acute Ischemic Stroke

Sponsor: Shaanxi Micot Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

Summary

MT200605 is an agonist of the receptor tyrosine kinase B (TrkB). It exerts brain-derived neurotrophic factor (BDNF)-like effects, protecting the structure and function of neural tissues in the brain. Simultaneously, it enhances ATP synthesis in the mitochondria of the striatum and bolsters antioxidant and free radical-scavenging capabilities. MT200605 is anticipated to confer pharmacological benefits including the reduction of neuronal apoptosis, antioxidant/free radical scavenging activity, anti-inflammatory effects, modulation of neuronal excitability, and amelioration of cerebral ischemic injury in patients with ischemic stroke. This Phase II exploratory study will be conducted across 32 research centers in China. It plans to enroll 360 patients diagnosed with acute ischemic stroke within 24 hours of onset. Subjects will be randomized to receive either a high, medium, or low dose of MT200605 or a placebo, in addition to standard medical care. The primary efficacy endpoint is the proportion of subjects achieving a modified Rankin Scale (mRS) score of ≤1 at 3 months post-stroke. Secondary efficacy endpoints include the reduction in the National Institutes of Health Stroke Scale (NIHSS) score from baseline at day 14, among others.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of MT200605 in Patients With Acute Ischemic Stroke.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2025-10

Completion Date

2026-06

Last Updated

2025-10-03

Healthy Volunteers

No

Interventions

DRUG

MT200605

MT200605 is an agonist of the receptor tyrosine kinase B (TrkB) and can enhances ATP synthesis in the mitochondria of the striatum and bolsters antioxidant and free radical-scavenging capabilities.

DRUG

MT200605

MT200605 is an agonist of the receptor tyrosine kinase B (TrkB) and can enhances ATP synthesis in the mitochondria of the striatum and bolsters antioxidant and free radical-scavenging capabilities.

DRUG

MT200605

MT200605 is an agonist of the receptor tyrosine kinase B (TrkB) and can enhances ATP synthesis in the mitochondria of the striatum and bolsters antioxidant and free radical-scavenging capabilities.

DRUG

Placebo

The placebo does not contain any active ingredients.

Locations (1)

BeiJing Tiantan Hospital

Beijing, Beijing Municipality, China