New stroke drug shows promise in recovery trial
NCT ID NCT05289947
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new medicine called MLC1501 to help people recover after a stroke. 303 adults who had a stroke within the past 2 to 10 days took either a high dose, low dose, or a placebo pill twice a day for 24 weeks. The main goal was to see if MLC1501 improves motor function and is safe.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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303 people
The number who actually took part.
- Started
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Jul 2023
- Finished
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Jul 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female. * ≥18 years old or legal age as per country requirement * Diagnosed with acute ischemic stroke with compatible brain imaging findings between 2 days to 10 days (inclusive) prior to inclusion. * NIHSS total score of 8 to 18 (inclusive) at the time of inclusion with a combined score of at least 3 on the NIHSS motor items 5A or 5B and/or 6A or 6B. * A candidate for active rehabilitation in the opinion of the treating physician. * Able to comply with the requirements of the protocol and provide written informed consent by patient or legal representative before any study-specific procedure is performed. Exclusion Criteria: * Pre-stroke modified Rankin score of \>1. * Contraindication to any of the study procedures. * Patients who became medically unstable within 24 hours after intravenous or endovascular thrombolysis or thrombectomy. * Intake of any herbal or traditional medicine within the past 30 days. * Participation in another investigational drug or device trial within the past 30 days. * Intake of warfarin in the past one week or expected to be on warfarin while in the study. * Women who are pregnant or wish to continue breastfeeding while in the study. Women of child-bearing potential may be included if they agree to strict abstinence or use of effective contraception, except systemically acting hormonal contraceptives. Hormone replacement therapy in menopausal/post-menopausal or surgically sterilized women is also not allowed while in the study. * Any known food allergy or hypersensitivity to Astragalus membranaceus, Ligusticum chuanxiong, Polygala tenuifolia, Angelica sinensis, or members of the Fabaceae/Leguminosae family (e.g., legume, pea, bean), Polygalaceae family (e.g., milkwort, snakeroot), Apiaceae/Umbelliferae family (e.g., anise, caraway, carrot, celery, dill, parsley, parsnip), or Quillaja bark (soapbark). * Evidence of other significant non-ischemic brain lesion which could affect long-term function or disability. * Evidence of advanced medical condition that would affect study assessment and follow-up, such as cancer, renal failure, liver cirrhosis, severe dementia, or psychosis. * Any other medical or psychiatric or cognitive condition which, in the study investigator's opinion, may jeopardize the patient by his/her participation in this study, may hamper his/her ability to complete procedures required in the study, affect study assessment and follow-up, or affect the validity of the study results.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Baguio General Hospital and Medical Center
Baguio City, Philippines
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Changi General Hospital
Singapore, Singapore, Singapore
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Jose R. Reyes Memorial Medical Center
Manila, Philippines
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Manila Doctors Hospita
Manila, Philippines
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Metro Davao Medical And Research Center
Davao City, Davao Region, Philippines
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National Neuroscience Institute (NNI) @ Tan Tock Seng Hospital (TTSH)
Singapore, Singapore, Singapore
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Quirino Memorial Medical Center
Manila, Manila, Philippines
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Raffles Hospital
Singapore, Singapore
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Singapore General Hospital
Singapore, Singapore
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University of Santo Tomas Hospital
Manila, Manila, Philippines
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West Visayas State University Medical Center
Iloilo City, Philippines
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a checklist and heart monitor stop repeat strokes?
- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next
- Stroke's hidden heart rhythm clue under investigation
- Zapping the spine while wearing a robotic ankle: a new way to help kids walk?
- Can a nurse and a neighbor help tame chronic disease?
- Can PET scans reveal hidden heart inflammation after a stroke?