Actively Recruiting
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate MT200605 for Acute Ischemic Stroke
Led by Shaanxi Micot Pharmaceutical Technology Co., Ltd. · Updated on 2025-10-03
360
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating MT200605, a drug that acts like brain-derived neurotrophic factor (BDNF) by protecting brain nerve tissues and supporting energy production in the brain's striatum. This study focuses on patients who have had an acute ischemic stroke within 24 hours, aiming to see if MT200605 can help reduce brain injury and improve recovery. The trial is a Phase II exploratory study conducted at 32 centers in China, enrolling 360 patients. Participants will be randomly assigned to receive either a low, medium, or high dose of MT200605 or a placebo. All patients will also receive standard medical care. The study drug or placebo is given twice daily by intravenous infusion for 14 consecutive days. The trial uses a double-blind design, meaning neither participants nor researchers know which treatment is given. During the study, researchers will assess patients using the modified Rankin Scale (mRS) to measure disability three months after the stroke. They will also evaluate changes in the National Institutes of Health Stroke Scale (NIHSS) score two weeks after treatment. Safety, brain function, and recovery will be closely monitored throughout the trial, which starts in October 2025 and continues until June 2026.
CONDITIONS
Brief 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 the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023
- Stroke onset to expected drug administration within 24 hours, including patients with or without reperfusion therapy
- NIHSS score at admission between 6 and 25 (inclusive), with upper and lower limb movement scores totaling at least 2 points
- Modified Rankin Scale (mRS) score of 0 to 1 before this stroke onset, with no obvious symptoms affecting NIHSS
- 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, hematomas, or subarachnoid hemorrhage; minor bleeding may be considered by the researcher
- Obvious consciousness disorders after disease onset, with NIHSS consciousness score greater than 1
- Transient ischemic attack (TIA)
- Acute ischemic stroke requiring endovascular treatment like mechanical thrombectomy or angioplasty
- Severe active kidney disease or renal insufficiency, serum creatinine greater than 1.5 times the upper limit of normal
- Severe active liver diseases, including acute or chronic hepatitis and liver cirrhosis, or ALT or AST levels greater than twice the upper limit of normal
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants receive standard medical treatment plus MT200605 or placebo through twice daily intravenous infusions for 14 consecutive days.
Twice daily visits for 14 consecutive days (in-person)
Duration - Approximately 3 months
Participants are assessed for recovery and outcomes after treatment, including evaluation of stroke-related disability.
1 visit around 90 days after stroke onset (in-person)
Trial Site Locations
Total: 1 location
1
BeiJing Tiantan Hospital
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
Research Team
Y
YongJun Wang, Doctor
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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