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New stroke drug shows promise in recovery trial

NCT ID NCT05289947

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

303 people

The number who actually took part.

Started

Jul 2023

Finished

Jul 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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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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

  • Baguio General Hospital and Medical Center

    Baguio City, Philippines

  • Changi General Hospital

    Singapore, Singapore, Singapore

  • Jose R. Reyes Memorial Medical Center

    Manila, Philippines

  • Manila Doctors Hospita

    Manila, Philippines

  • Metro Davao Medical And Research Center

    Davao City, Davao Region, Philippines

  • National Neuroscience Institute (NNI) @ Tan Tock Seng Hospital (TTSH)

    Singapore, Singapore, Singapore

  • Quirino Memorial Medical Center

    Manila, Manila, Philippines

  • Raffles Hospital

    Singapore, Singapore

  • Singapore General Hospital

    Singapore, Singapore

  • University of Santo Tomas Hospital

    Manila, Manila, Philippines

  • West Visayas State University Medical Center

    Iloilo City, Philippines

More trials for these conditions

Other studies related to the condition(s) this trial covers.