NeuroAiD Patient-Reported Outcomes in Patients With Mild to Moderate Ischemic Stroke
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorEVD Pharmacy and Medical Company Limited
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
MLC901
DrugMLC901 (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 stroke
Other interventionParticipants will receive standard treatment for acute ischemic stroke according to the study protocol for 12 weeks
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: MLC901 (NeuroAiD™ II) + Standard TreatmentExperimental treatment 2 interventions
Group B: Standard TreatmentActive comparator 1 intervention
Trial outcomes
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 142
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 143
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 144
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.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 122
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 123
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 124
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 12Sponsors and contacts
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Source ClinicalTrials.gov