MT200605 for treating 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.

This trial will test whether MT200605, given within 24 hours of stroke onset, can help adults with acute ischemic stroke recover better than placebo.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 360 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shaanxi Micot Pharmaceutical Technology Co., Ltd. (industry)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07205328 on ClinicalTrials.gov

What this trial studies

This Phase II, randomized, placebo-controlled study plans to enroll 360 adults with acute ischemic stroke at 32 centers in China and randomize them to high, medium, low doses of MT200605 or placebo alongside standard care. Eligible patients are 18–80 years old, present within 24 hours of symptom onset, and have NIHSS scores of 6–25 with at least moderate limb motor deficit. MT200605 is a TrkB agonist with BDNF-like properties that aims to reduce neuronal apoptosis, support mitochondrial ATP production, and reduce oxidative stress and inflammation. The trial will compare functional outcomes across dose groups and placebo; the brief does not specify the exact primary endpoint in full.

Who should consider this trial

Good fit: Adults aged 18–80 with acute ischemic stroke presenting within 24 hours, NIHSS 6–25, pre-stroke mRS 0–1, and able to provide informed consent are the intended participants.

Not a fit: Patients with evidence of intracranial hemorrhage on imaging or other exclusion criteria that preclude participation are unlikely to receive benefit from this investigational treatment.

Why it matters

Potential benefit: If successful, MT200605 could improve neurological recovery after acute ischemic stroke by protecting neurons and reducing damage from ischemia.

How similar studies have performed: BDNF/TrkB-mimetic approaches have shown neuroprotective effects in animal stroke models, but clinical success in humans has been limited and this specific agent remains relatively untested in large trials.

Eligibility criteria

Inclusion Criteria:

1. Age between 18 and 80 years old (inclusive), male or female ;
2. Diagnosed with ischemic stroke according to the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023";
3. 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;
4. 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;
5. 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;
6. Able to understand and cooperate with the process of this study, and voluntarily sign the informed consent.

Exclusion Criteria:

1. 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;
2. 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;
3. Transient ischemic attack (TIA);
4. This acute ischemic stroke requires endovascular treatment (including intravenous thrombolysis, mechanical thrombectomy, angioplasty);
5. At the time of admission, already known severe active kidney disease, renal insufficiency; or serum creatinine \> 1.5 × ULN;
6. Severe active liver diseases, such as acute hepatitis, chronic active hepatitis, liver cirrhosis, etc.; or ALT or AST \> 2.0 × ULN;

Where this trial is running

Beijing, Beijing Municipality

• BeiJing Tiantan Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: YongJun Wang, Doctor

Conditions: Acute Ischemic Stroke