NeuroAiD Patient-Reported Outcomes in Patients With Mild to Moderate Ischemic Stroke

NCT07828210 | Recruiting Phase 4

• 1 other identifier: EFSA2026_01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, controlled, open-label study of MLC901 (NeuroAiD™ II) in patients with mild to moderate ischemic stroke. Eligible participants will be randomized in a 1:1 ratio to receive MLC901 in combination with standard treatment or standard treatment alone for 12 weeks.

Conditions

Stroke; Stroke, Acute Ischemic; Stroke, Ischemic; Stroke, Cryptogenic; Stroke, Cardiovascular

Keywords

MLC901; NAiD-PRO; stroke recovery; neurorestoration; NeuroAiD II; ischemic stroke; stroke

Outcome Measures

Primary Outcomes (5)

• EuroQol 5-Dimension 5-Level (EQ-5D-5L)

  The EQ-5D-5L is a patient-reported measure of health-related quality of life covering five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of response, ranging from 1 (no problems) to 5 (extreme problems/unable to perform), with higher levels indicating worse health status.

  Baseline, Day 7 and Day 14

• EuroQol Visual Analogue Scale (EQ-VAS)

  The EQ-VAS records the participant's self-rated health on a vertical visual analogue scale ranging from 0 to 100, where 0 represents the worst health the participant can imagine and 100 represents the best health the participant can imagine.

  Baseline, Day 7 and Day 14

• Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM-1.4)

  The Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM-1.4) is a 14-item patient-reported questionnaire used to assess treatment satisfaction across four domains: effectiveness (3 items), side effects (5 items), convenience (3 items), and global satisfaction (3 items). Items use 5- or 7-point Likert-type response scales and dichotomous (Yes/No) responses, as applicable. TSQM 1.4 domain scores range from 0 to 100, with higher scores representing higher satisfaction in that domain.

  Baseline, Day 7 and Day 14

• Adverse Events

  Frequency, incidence rate, and severity of adverse events during the study period.

  From baseline through Week 12, and at the optional Week 24 follow-up visit.

• Hemorrhagic Complications

  Presence or absence of hemorrhagic complications during the study period.

  From baseline through Week 12, and at the optional Week 24 follow-up visit.

Secondary Outcomes (5)

• Modified Rankin Scale (mRS)

  Baseline, Week 4 and Week 12

• Fugl-Meyer Assessment (FMA)

  Baseline, Day 14, Week 4 and Week 12

• National Institutes of Health Stroke Scale (NIHSS)

  Baseline, Day 14 and Week 12

• Maximum Muscle Strength

  Baseline, Day 7, Day 14, Day 21, Week 4, Week 8 and Week 12

• Cerebral Infarct Volume on Magnetic Resonance Imaging (MRI)

  Baseline and Week 12 (±7 days)

Study Arms (2)

MLC901 (NeuroAiD™ II) + Standard Treatment

EXPERIMENTAL

Participants will receive MLC901 (NeuroAiD™ II) (400 mg, 2 capsules per dose, 3 times daily) in combination with standard treatment according to the protocol for 12 weeks.

Drug: MLC901; Other: Standard treatment for acute ischemic stroke

Standard Treatment

ACTIVE COMPARATOR

Participants will receive standard treatment according to the protocol for 12 weeks.

Other: Standard treatment for acute ischemic stroke

Interventions

MLC901 DRUG

MLC901 (NeuroAiD™ II) 400 mg hard capsules, administered orally at a dose of 2 capsules three times daily for 12 weeks, in combination with standard treatment according to the protocol.

Also known as: NeuroAiD™ II

MLC901 (NeuroAiD™ II) + Standard Treatment

Standard treatment for acute ischemic stroke OTHER

Participants will receive standard treatment for acute ischemic stroke according to the study protocol for 12 weeks

MLC901 (NeuroAiD™ II) + Standard Treatment; Standard Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female.
• Aged 18 to 80 years, inclusive.
• Diagnosed with ischemic stroke, with brain imaging findings consistent with the diagnosis, and enrolled 2-10 days after stroke onset.
• Baseline National Institutes of Health Stroke Scale (NIHSS) score of 1-15 at the time of screening.
• Clinically stable at the time of enrollment.
• Considered by the treating physician to be a suitable candidate for active rehabilitation.
• Able to comply with the requirements of the study protocol and has provided written informed consent to participate in the study, either personally or through a legally authorized representative, as applicable, before any study-specific procedures are performed.

You may not qualify if:

• Other neurological or psychiatric disorders that may interfere with study assessments, including:
• Hemorrhagic stroke.
• Evidence of other significant non-ischemic brain lesions that may affect long-term functional outcomes or disability.
• Evidence of progressive medical conditions that may interfere with study assessments or follow-up (e.g., cancer, kidney failure, liver cirrhosis, severe dementia, or psychiatric disorders).
• Any medical, psychiatric, or cognitive condition that, in the investigator's opinion, may place the participant at risk during study participation, interfere with the conduct of study procedures, compromise study follow- up, or confound the study results.
• Contraindication to any study procedure.
• Clinically unstable condition within 24 hours after thrombolysis (intravenous/endovascular) or thrombectomy.
• Use of Cerebrolysin, piracetam, erythropoietin, edaravone, or vinpocetine within 30 days prior to enrollment.
• Current use of finished medicinal products or herbal medicinal products containing ingredients that overlap with any component of MLC901.
• Participation in another investigational drug or medical device trial within 30 days prior to enrollment.
• Pregnancy or breastfeeding. Women of childbearing potential are eligible only if they commit to complete abstinence from sexual intercourse or use effective contraception (excluding systemic hormonal contraceptives). Participants receiving hormone replacement therapy are not eligible (this applies to premenopausal, postmenopausal, or surgically sterilized women).
• History of food allergy or hypersensitivity to any component of MLC901

Sponsors & Collaborators

• EVD Pharmacy and Medical Company Limited: lead

Study Sites (1)

Traditional Medicine Institute

Ho Chi Minh City, Vietnam

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Myocardial Infarction

Interventions

Neuroaid

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: September 10, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Locations

VN (1)