Actively Recruiting
A Clinical Trial of MT200605 for the Treatment of Acute Ischemic Stroke
Led by Shaanxi Micot Pharmaceutical Technology Co., Ltd. · Updated on 2025-10-03
360
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Clinical Trial of MT200605 for the Treatment of Acute Ischemic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years old (inclusive), male or female
- Diagnosed with ischemic stroke according to Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023
- Time from stroke onset to planned study drug administration within 24 hours, including patients with or without intravenous thrombolysis treatment
- NIHSS score at admission between 6 and 25 (inclusive), with a combined score of at least 2 points for upper and lower limb movement
- Modified Rankin Scale score before stroke onset is 0 or 1 without symptoms affecting NIHSS score
- Able to understand and cooperate with the study process and voluntarily sign informed consent
You will not qualify if you...
- Imaging shows intracranial hemorrhagic disorders such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, or subarachnoid hemorrhage
- Obvious consciousness disorder after stroke onset with NIHSS consciousness item score greater than 1
- Transient ischemic attack (TIA)
- Acute ischemic stroke requiring endovascular treatment including intravenous thrombolysis, mechanical thrombectomy, or angioplasty
- Known severe active kidney disease or renal insufficiency; serum creatinine greater than 1.5 times the upper limit of normal
- Severe active liver disease such as acute hepatitis, chronic active hepatitis, liver cirrhosis; ALT or AST greater than 2 times the upper limit of normal
AI-Screening
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Trial Site Locations
Total: 1 location
1
BeiJing Tiantan Hospital
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
Research Team
Y
YongJun Wang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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