Trials / Completed
CompletedNCT05289947
MLC1501 Study Assessing Efficacy in Post STrOke Subjects With mOtor Deficits
A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy and Safety of MLC1501 in Patients With Stroke
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 303 (actual)
- 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 trial of MLC1501 in patients with stroke. Eligible participants will be randomized in a 1:1:1 ratio to orally receive MLC1501 high-dose twice a day, MLC1501 low-dose twice a day, or matching placebo for 24 weeks.
Detailed description
A total of 300 patients will be included with approximately 100 patients randomized to each treatment arm. Randomization will be performed centrally and stratified according to the following factors at the time of randomization: country, National Institute of Health Stroke Scale (NIHSS) (8 to 12, 13 to 18) and received either intravenous or endovascular thrombolysis/thrombectomy (no, yes). Efficacy clinical assessments will include Fugl-Meyer motor Assessment (FMA), modified Rankin Scale (mRS), Patient Reported outcome Measurement Information System - Global Health (PROMIS-10) and NIHSS. Each patient 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.
Conditions
- Stroke
- Stroke, Ischemic
- Strokes Thrombotic
- Stroke Sequelae
- Stroke, Cardiovascular
- Stroke, Embolic
- Stroke, Cryptogenic
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Placebo | Caramel, chocolate brown, flavor (E\_1982648), dextrin |
| DRUG | MLC1501 | Powdered extract of Radix astragali, Rhizoma chuanxiong, Radix angelica sinensis, Radix polygala |
Timeline
- Start date
- 2023-07-21
- Primary completion
- 2025-07-18
- Completion
- 2025-07-18
- First posted
- 2022-03-22
- Last updated
- 2025-12-09
Locations
11 sites across 2 countries: Philippines, Singapore
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05289947. Inclusion in this directory is not an endorsement.