Status:
RECRUITING
A Clinical Trial of MT200605 for the Treatment of Acute Ischemic Stroke
Lead Sponsor:
Shaanxi Micot Pharmaceutical Technology Co., Ltd.
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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. ...
Eligibility Criteria
Inclusion
- 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";
- The time from the onset of the disease to the expected administration of the investigational drug will be within 24 hours., including patients who have not received reperfusion therapy or those have received intravenous thrombolysis treatment;
- The NIHSS score at admission is between 6 and 25 (inclusive), and the sum of the scores for the 5th（upper limb movement） and the 6th（ lower limb movement） is ≥ 2 points;
- The mRS score before this onset of stroke is 0 to 1, and there are no obvious clinical symptoms and signs that affect the NIHSS score;
- Able to understand and cooperate with the process of this study, and voluntarily sign the informed consent.
Exclusion
- Imaging examinations show concurrent intracranial hemorrhagic disorders: such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc. If there is minor bleeding, it could be determined based on the researcher's judgment whether the subject was suitable for inclusion;
- After the onset of the disease, obvious consciousness disorders occurre, and the score of the NIHSS item for the 1a level of consciousness is \>1 point;
- Transient ischemic attack (TIA);
- This acute ischemic stroke requires endovascular treatment (including intravenous thrombolysis, mechanical thrombectomy, angioplasty);
- At the time of admission, already known severe active kidney disease, renal insufficiency; or serum creatinine \> 1.5 × ULN;
- Severe active liver diseases, such as acute hepatitis, chronic active hepatitis, liver cirrhosis, etc.; or ALT or AST \> 2.0 × ULN;
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT07205328
Start Date
October 1 2025
End Date
June 1 2026
Last Update
October 3 2025
Active Locations (1)
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1
BeiJing Tiantan Hospital
Beijing, Beijing Municipality, China, 100070