Clinical trial NCT05289947: MLC1501 Study Assessing Efficacy in Post STrOke Subjects with MOtor Deficits
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy and Safety of MLC1501 in Patients with Stroke
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Stroke
Stroke, Ischemic
Strokes Thrombotic
Stroke Sequelae
Stroke, Cardiovascular
Stroke, Embolic
Stroke, Cryptogenic
Keywords: stroke
MLC1501
MAESTOSO
stroke recovery
neurorestoration
Lead sponsor: Moleac Pte Ltd.
Sponsor class: INDUSTRY
First posted: 2022-03-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fugl-Meyer motor Assessment (FMA)
timeFrame: 24 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: up to 24 weeks
measure: Fugl-Meyer motor Assessment (FMA)
timeFrame: 12 and 24 weeks
measure: modified Rankin Scale (mRS)
timeFrame: 4, 12 and 24 weeks
measure: Patient Reported Outcome Measurement Information System - Global Health (PROMIS-10)
timeFrame: 4, 12 and 24 weeks
measure: National Institute of Health Stroke Scale (NIHSS)
timeFrame: 12 and 24 weeks
Other outcomes:
Locations:
city: Baguio
country: Philippines
facility: Baguio General Hospital and Medical Center
city: Davao
country: Philippines
facility: Metro Davao Medical And Research Center
city: Iloilo City
country: Philippines
facility: West Visayas State University Medical Center
city: Manila
country: Philippines
facility: Jose R. Reyes Memorial Medical Center
city: Manila
country: Philippines
facility: Manila Doctors Hospita
city: Manila
country: Philippines
facility: Quirino Memorial Medical Center
city: Manila
country: Philippines
facility: University of Santo Tomas Hospital
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Singapore
country: Singapore
facility: National Neuroscience Institute (NNI) @ Tan Tock Seng Hospital (TTSH)
city: Singapore
country: Singapore
facility: Raffles Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Departments of Pharmacology and Psychological Medicine, National University of Singapore
name: Christopher Chen, BMBCh, MRCP, FAMS, FRCPE
role: PRINCIPAL_INVESTIGATOR
References: