Acute Ischemic StrokePhase 2NCT07205328
A Clinical Trial of MT200605 for the Treatment of Acute Ischemic Stroke
A Phase 2 study testing MT200605 in people with Acute Ischemic Stroke, run by Shaanxi Micot Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- MT200605
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2025to 24 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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
- Being tested
- MT200605, Placebo
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT200605Drug
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.
MT200605Drug
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.
MT200605Drug
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.
PlaceboDrug
The placebo does not contain any active ingredients.
| Study group | Role | What they receive |
|---|---|---|
| MT200605 Low-dose group | Experimental | Standard medical treatment + MT200605 10mg, twice daily, intravenous infusion, for 14 consecutive days; Receives: Drug: MT200605 |
| MT200605 Medium-dose group | Experimental | Standard medical treatment + MT200605 20mg, twice daily, intravenous infusion, for 14 consecutive days; Receives: Drug: MT200605 |
| MT200605 High-dose group | Experimental | Standard medical treatment + MT200605 40mg, twice daily, intravenous infusion, for 14 consecutive days Receives: Drug: MT200605 |
| Placebo Group | Placebo comparator | Standard medical treatment + placebo, twice daily, intravenous infusion, for 14 consecutive days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale（mRS）
Measured: 90 ± 5 days after the onset of stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start30 Sep 2025
- Primary completion24 Jun 2026
- Study completion24 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205328
- Sponsor's protocol ID
- MT200605-II-C01
- Status last verified
- Nov 2026
- First submitted
- 25 Sep 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07205328
- Acronym / sponsor ID
- MT200605-II-C01
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 24 Jun 2026 (actual)
- Study completion
- 24 Jun 2026 (actual)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MT200605 Low-dose group | Experimental | Drug: MT200605Standard medical treatment + MT200605 10mg, twice daily, intravenous infusion, for 14 consecutive days; |
| MT200605 Medium-dose group | Experimental | Drug: MT200605Standard medical treatment + MT200605 20mg, twice daily, intravenous infusion, for 14 consecutive days; |
| MT200605 High-dose group | Experimental | Drug: MT200605Standard medical treatment + MT200605 40mg, twice daily, intravenous infusion, for 14 consecutive days |
| Placebo Group | Placebo comparator | Drug: PlaceboStandard medical treatment + placebo, twice daily, intravenous infusion, for 14 consecutive days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT200605MT200605 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 High-dose group |
| MT200605MT200605 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 Low-dose group |
| MT200605MT200605 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 Medium-dose group |
| PlaceboThe placebo does not contain any active ingredients. | Drug | Placebo Group |
Primary outcome
Modified Rankin Scale（mRS）
Time frame: 90 ± 5 days after the onset of stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MT200605 in people with Acute Ischemic Stroke, run by Shaanxi Micot Pharmaceutical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale（mRS） (time frame: 90 ± 5 days after the onset of stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.