This is a multi-center, randomized, double-blind, placebo-controlled, dose-response study of MLC1501 in patients with stroke. Eligible participants will be randomized in a 1:1:1 ratio to orally receive MLC1501 low-dose twice a day, MLC1501 high-dose twice a day, or matching placebo for 24 weeks.
Male or female.
18 years old or older.
Diagnosed with acute ischemic stroke with compatible brain imaging findings between 2 days to 7 days prior to inclusion. Patients who undergo intravenous or endovascular thrombolysis or thrombectomy must be considered stable for at least 24 hours post-procedure prior to inclusion.
NIHSS total score of 8 to 18 (inclusive) at the time of inclusion with a combined score of at least 2 on the NIHSS motor items 5A or 5B and/or 6A or 6B.
Pre-stroke modified Rankin score of >1.
Contraindication to any of the study procedures.
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.
Parallel
MLC1501
DrugPowdered extract of Radix astragali, Rhizoma chuanxiong, Radix angelica sinensis, Radix polygala
Placebo
Other interventionCaramel, chocolate brown, flavor (E\_1982648), dextrin
modified Rankin Scale
The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 (no symptoms at all) to 5 (severe disability). A separate category of 6 is usually added for patients who expire.
Fugl-Meyer motor Assessment (FMA)
Action Research Arm Test (ARAT)
Timed 10-Meter Walk Test (10MWT)
National Institute of Health Stroke Scale total and motor scores
The maximum possible score is 42 (severe), with the minimum score being a 0 (no symptoms)
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This trial is not recruiting at the moment. You can still explore other options:
