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

NCT07205328 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2025-10-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Shaanxi Micot Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2026-05-31
Completion
2026-06-30

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07205328 on ClinicalTrials.gov