ClinicalTrials.gg
RecruitingNCT07828210NAiD-PROUpdated Oct 20, 2026

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

A Phase 4 interventional study of MLC901 and Standard treatment for acute ischemic stroke in Stroke, Stroke, Acute Ischemic and Stroke, Ischemic, sponsored by EVD Pharmacy and Medical Company Limited. Recruiting at 1 site in Vietnam. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-20.

Primary conditionIschemic StrokeRegistry: StrokeReclassifiedWhy we changed it
Registry
Stroke — the first condition term the registry derived for this study.
ClinicalTrials.gg
Ischemic Stroke
Why
  1. The study's listed conditions name Ischemic Stroke, a narrower term within Stroke.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by EVD Pharmacy and Medical Company Limited · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Updated Oct 20, 2026Eligibility revisedPrimary outcomes revisedGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 25 studies in Ischemic Stroke with a site in Vietnam — 8 open to participants now, 9 under way, 4 of them phase 3. Ischemic Stroke · Vietnam.

Planned enrollment
16th of 22
80 · median 133
Started
2026
with 4 others
Phase 4
Only one
of the 25
Registered
24th of 25
by date
Lead sponsor
1 of 25
EVD Pharmacy and Medical Company Limited

Among the 25 studies in Ischemic Stroke with a site in Vietnam, this one is the 16th largest by planned enrollment of the 22 interventional ones that give a count, is one of 5 that started in 2026, is the only one in phase 4, and was the 24th registered.

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

Browse Ischemic Stroke studies →

Open to participants now

8 of the 25 studies in Ischemic Stroke with a site in Vietnam are open now. Recruiting first, the newest first:

2 more — sign in →

All 8 open studies →

A study can be open while its sites in Vietnam have not opened yet or have stopped. Only those recruiting at a site in Vietnam →

Who these studies take

Of the 655 Ischemic Stroke studies recruiting now, 394 (60%) set no upper age limit and 62 (9%) stop at 75 or younger; 26 take children under 18; 41 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 25 studies in Ischemic Stroke with a site in Vietnam, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Stroke
  • Stroke, Acute Ischemic
  • Stroke, Ischemic
  • Stroke, Cryptogenic
  • Stroke, Cardiovascular

Browse trials for

Keywords

  • MLC901
  • NAiD-PRO
  • stroke recovery
  • neurorestoration
  • NeuroAiD II
  • ischemic stroke
  • stroke
04

In context

Ischemic Stroke Reclassified

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 80 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

This is the only study on the registry with EVD Pharmacy and Medical Company Limited as lead sponsor.

Compared within Ischemic Stroke, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Stroke. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

The criteria were revised on the registry on Oct 20, 2026. See what changed

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Aged 18 to 80 years, inclusive.
  2. Diagnosed with ischemic stroke, with brain imaging findings consistent with the diagnosis, and enrolled 2-10 days after stroke onset.
  3. Baseline National Institutes of Health Stroke Scale (NIHSS) score of 8-15 at the time of screening.
  4. Clinically stable at the time of enrollment.
  5. Considered by the treating physician to be a suitable candidate for active rehabilitation.
  6. Able to comply with the requirements of the study protocol and has provided written to participate in the study, either personally or through a legally authorized representative, as applicable, before any study-specific procedures are performed.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. to any study procedure.
  3. Clinically unstable condition within 24 hours after thrombolysis (intravenous/endovascular) or thrombectomy.
  4. Use of Cerebrolysin, piracetam, erythropoietin, edaravone, or vinpocetine within 30 days prior to enrollment.
  5. Current use of finished medicinal products or herbal medicinal products containing ingredients that overlap with any component of MLC901.
  6. Participation in another drug or medical device trial within 30 days prior to enrollment.
  7. Pregnancy or breastfeeding. Women of are eligible only if they commit to complete abstinence from sexual intercourse or use effective (excluding systemic hormonal contraceptives). Participants receiving hormone replacement therapy are not eligible (this applies to premenopausal, , or surgically sterilized women).
  8. History of food allergy or to any component of MLC901
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

06

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    MLC901 (NeuroAiD™ II) + Standard Treatment

    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

  • Active comparator
    Standard Treatment

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

    Other: Standard treatment for acute ischemic stroke

Interventions

  • DrugMLC901

    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

  • OtherStandard treatment for acute ischemic stroke

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

07

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, Day 7 and Day 14

  2. 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.

    Time frame: Baseline, Day 7 and Day 14

  3. 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.

    Time frame: Baseline, Day 7 and Day 14

  4. Adverse Events

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

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

  5. Hemorrhagic Complications

    Presence or absence of hemorrhagic complications during the study period.

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

Secondary outcomes

  1. 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).

    Time frame: Baseline, Week 4 and Week 12

  2. 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.

    Time frame: Baseline, Day 14, Week 4 and Week 12

  3. 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.

    Time frame: Baseline, Day 14 and Week 12

  4. Maximum Muscle Strength

    Maximum muscle strength will be assessed using the Mobie fixed-belt hand-held dynamometer.

    Time frame: Baseline, Day 7, Day 14, Day 21, Week 4, Week 8 and Week 12

  5. Cerebral Infarct Volume on Magnetic Resonance Imaging (MRI)

    Change in cerebral infarct volume from baseline will be assessed using magnetic resonance imaging (MRI).

    Time frame: Baseline and Week 12 (±7 days)

08

Study locations

1 of 1 sites recruiting
  • Traditional Medicine Institute
    Ho Chi Minh City, Vietnam
    Recruiting
    • Thi Lan Huong Dinh, MD · Contactdinhlanhuonghmu@gmail.com · +84 983 699 665
    • Thanh Tuyen Nguyen · Contact
    • Nguyen Hao Nhien Le · Principal investigator
    • Le Anh Trung Nguyen · Sub investigator
    • Tri Cuong Nguyen · Sub investigator
    • Thi My Phuong Ho · Sub investigator
    • Dinh Hung Nguyen · Sub investigator
    • Thi Phuoc Hoa Ta · Sub investigator
    • Ngoc Ha Phuong Dang · Sub investigator
    • Le Bao Quyen Nguyen · Sub investigator
    • Thi Lan Huong Dinh · Principal investigator
09

References and documents

Individual participant data

Plan to share: Undecided — Once decided, only anonymized IPD may be shared with other collaborative stroke trials consortiums.

No publications or documents are linked to this record.

10

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Sep 2027, 12 months after the start.

Of 83 phase 4 interventional studies under Ischemic Stroke, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 41. This study's planned 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 14, 2026
First posted
Sep 18, 2026
StartActual
Sep 10, 2026
Primary completionEst.
Sep 2027
CompletionEst.
Dec 2027
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Eligibility
1 inclusion criterion edited, 1 removed
What changed in the criteria
Inclusion criteria
  • RemovedMale or female.
  • EditedBaseline National Institutes of Health Stroke Scale (NIHSS) score of 18-15 at the time of screening.
Oct 20, 2026
Primary outcomes
2 description edited
What changed in the outcomes
  • DescriptionEuroQol 5-Dimension 5-Level (EQ-5D-5L): how it is measured was reworded
  • DescriptionTreatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM-1.4): how it is measured was reworded
Sep 30, 2026
Secondary outcomes
1 description edited
What changed in the outcomes
  • DescriptionFugl-Meyer Assessment (FMA): how it is measured was reworded
Sep 30, 2026
Show all 2 updates
  1. Oct 20, 2026
    Eligibility 1 inclusion criterion edited, 1 removed
    What changed in the criteria
    Inclusion criteria
    • RemovedMale or female.
    • EditedBaseline National Institutes of Health Stroke Scale (NIHSS) score of 18-15 at the time of screening.
    + 1 other change: verification date
  2. Sep 30, 2026
    Primary outcomes 2 description edited
    What changed in the outcomes
    • DescriptionEuroQol 5-Dimension 5-Level (EQ-5D-5L): how it is measured was reworded
    • DescriptionTreatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM-1.4): how it is measured was reworded
    Secondary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionFugl-Meyer Assessment (FMA): how it is measured was reworded

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT07828210
Lead sponsor
EVD Pharmacy and Medical Company Limited
Responsible party
Sponsor
First posted
Sep 18, 2026
Start date
Sep 10, 2026
Primary completion
Sep 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Oct 20, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Neuroaid

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