Trials / Not Yet Recruiting
Not Yet RecruitingNCT05046106
MLC1501 Study Assessing Efficacy in STROke Recovery
A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Efficacy and Safety Study of MLC1501 in Patients With Stroke
- Status
- Not Yet Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 540 (estimated)
- Sponsor
- Moleac Pte Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
A total of 540 patients will be included with approximately 180 participants randomized to each treatment arm. Randomization will be performed centrally and stratified according to the following factors at the time of randomization: NIHSS (8 to 12, 13 to 18), age (\<65 years, ≥65 years) and received either intravenous or endovascular thrombolysis/thrombectomy (no, yes). Efficacy clinical assessments will include mRS, FMA, ARAT, 10MWT, NIHSS, Barthel Index, EQ-5D-5L, MoCA, PROMIS-10, and occurrence of recurrent vascular event. Each participant will undergo standard safety assessments including physical exam and laboratory parameters, and be observed for adverse events for the duration of the study. Electrocardiogram (ECG), hematology, clinical chemistry, coagulation, and urinalysis will be performed at specified intervals. The C-SSRS will be used to screen for suicidal ideation and behavior. Blood samples will be collected and stored for future studies on circulating compounds and pharmacokinetics.
Conditions
- Stroke
- Stroke, Ischemic
- Strokes Thrombotic
- Stroke Sequelae
- Stroke, Cardiovascular
- Stroke, Embolic
- Stroke, Cryptogenic
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MLC1501 | Powdered extract of Radix astragali, Rhizoma chuanxiong, Radix angelica sinensis, Radix polygala |
| OTHER | Placebo | Caramel, chocolate brown, flavor (E\_1982648), dextrin |
Timeline
- Start date
- 2025-01-01
- Primary completion
- 2028-09-01
- Completion
- 2028-12-01
- First posted
- 2021-09-16
- Last updated
- 2023-03-16
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05046106. Inclusion in this directory is not an endorsement.