StrokePhase 4NAiD-PRONCT07828210
NeuroAiD Patient-Reported Outcomes in Patients With Mild to Moderate Ischemic Stroke
A Phase 4 study testing MLC901 and Standard treatment for acute ischemic stroke in people with Stroke and Stroke, Acute Ischemic, run by EVD Pharmacy and Medical Company Limited at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Stroke, Acute Ischemic, Stroke, Ischemic
- What is being tested?
- MLC901 and Standard treatment for acute ischemic stroke
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteVietnam
- Study dates
- 10 Sep 2026to Dec 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 8-15 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Traditional Medicine Institute
Ho Chi Minh City
Thi Lan Huong Dinh, MD, +84 983 699 665, dinhlanhuonghmu@gmail.com
Thanh Tuyen Nguyen
About this study
Official title: A Randomized, Controlled Study Evaluating the Efficacy and Safety of MLC901 (NeuroAiD™ II) in Patients With Mild to Moderate Ischemic Stroke.
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.
Read the detailed description
A total of 80 patients will be included, with approximately 40 patients randomized to each treatment group.
Group 1: Participants will receive MLC901 (400 mg, 2 capsules per dose, 3 times daily) in combination with standard treatment according to the protocol.
Group 2: Participants will receive standard treatment according to the protocol.
The treatment period will last for 12 weeks. An optional follow-up visit at Week 24 may be conducted to assess the durability of the treatment effect.
Efficacy assessments will include the EuroQol 5-Dimension 5-Level (EQ-5D-5L), EuroQol Visual Analogue Scale (EQ-VAS), Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM-1.4), Fugl-Meyer Assessment (FMA), National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), muscle strength assessment, and MRI-based assessment of cerebral infarct volume.
Safety will be assessed throughout the study through the monitoring of adverse events and hemorrhagic complications.
- Conditions
- Stroke, Stroke, Acute Ischemic, Stroke, Ischemic, Stroke, Cryptogenic, Stroke, Cardiovascular
- Being tested
- MLC901, Standard treatment for acute ischemic stroke
- Keywords
- MLC901, NAiD-PRO, stroke recovery, neurorestoration, NeuroAiD II, ischemic stroke, stroke
- Medical subject headings
- Stroke, Ischemic Stroke, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLC901Drug
Also called NeuroAiD™ II
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.
Standard treatment for acute ischemic strokeOther
Participants will receive standard treatment for acute ischemic stroke according to the study protocol for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard treatment for acute ischemic stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Day 7 and Day 14
Adverse Events
Frequency, incidence rate, and severity of adverse events during the study period.
Measured: 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.
Measured: From baseline through Week 12, and at the optional Week 24 follow-up visit.
Secondary outcomes (5)
Modified Rankin Scale (mRS)
The modified Rankin Scale (mRS) is used to assess the degree of disability or dependence in daily activities following stroke. Scores range from 0 (no symptoms) to 6 (death).
Measured: Baseline, Week 4 and Week 12
Fugl-Meyer Assessment (FMA)
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation, and joint functioning following stroke. The total score ranges from 0 to 226, with higher scores indicating better functional performance and less impairment.
Measured: Baseline, Day 14, Week 4 and Week 12
National Institutes of Health Stroke Scale (NIHSS)
The National Institutes of Health Stroke Scale (NIHSS) is used to assess neurological impairment following stroke. Scores range from 0 to 42, with higher scores indicating greater neurological impairment.
Measured: Baseline, Day 14 and Week 12
Maximum Muscle Strength
Maximum muscle strength will be assessed using the Mobie fixed-belt hand-held dynamometer.
Measured: Baseline, Day 7, Day 14, Day 21, Week 4, Week 8 and Week 12
Cerebral Infarct Volume on Magnetic Resonance Imaging (MRI)
Change in cerebral infarct volume from baseline will be assessed using magnetic resonance imaging (MRI).
Measured: Baseline and Week 12 (±7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start10 Sep 2026
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EVD Pharmacy and Medical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828210
- Sponsor's protocol ID
- EFSA2026_01
- Acronym
- NAiD-PRO
- Status last verified
- Oct 2026
- First submitted
- 14 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Once decided, only anonymized IPD may be shared with other collaborative stroke trials consortiums.