NCT07205328

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

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.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Shaanxi Micot Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-05-01
• Completion: 2026-06-01
• First posted: 2025-10-03
• Last updated: 2025-10-03

Locations

1 site across 1 country: China