NeuroAiD Patient-Reported Outcomes in Patients With Mild to Moderate Ischemic Stroke (NAiD-PRO)
2026년 9월 14일 업데이트: EVD Pharmacy and Medical Company Limited
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.
연구 개요
상태
모병
상세 설명
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.
연구 유형
중재적
등록 (추정된)
80
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ho Chi Minh City, 베트남
- 모병
- Traditional Medicine Institute
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연락하다:
- Thi Lan Huong Dinh, MD
- 전화번호: +84 983 699 665
- 이메일: dinhlanhuonghmu@gmail.com
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연락하다:
- Thanh Tuyen Nguyen
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수석 연구원:
- Nguyen Hao Nhien Le
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부수사관:
- Le Anh Trung Nguyen
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부수사관:
- Tri Cuong Nguyen
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부수사관:
- Thi My Phuong Ho
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부수사관:
- Dinh Hung Nguyen
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부수사관:
- Thi Phuoc Hoa Ta
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부수사관:
- Ngoc Ha Phuong Dang
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부수사관:
- Le Bao Quyen Nguyen
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수석 연구원:
- Thi Lan Huong Dinh
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
다른 이름들:
Participants will receive standard treatment for acute ischemic stroke according to the study protocol for 12 weeks
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활성 비교기: Standard Treatment
Participants will receive standard treatment according to the protocol for 12 weeks.
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Participants will receive standard treatment for acute ischemic stroke according to the study protocol for 12 weeks
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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EuroQol 5-Dimension 5-Level (EQ-5D-5L)
기간: Baseline, Day 7 and Day 14
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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.
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Baseline, Day 7 and Day 14
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EuroQol Visual Analogue Scale (EQ-VAS)
기간: Baseline, Day 7 and Day 14
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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.
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Baseline, Day 7 and Day 14
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Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM-1.4)
기간: Baseline, Day 7 and Day 14
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The TSQM-1.4 is a patient-reported questionnaire used to assess treatment satisfaction across the domains of effectiveness, side effects, convenience, and global satisfaction.
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Baseline, Day 7 and Day 14
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Adverse Events
기간: From baseline through Week 12, and at the optional Week 24 follow-up visit.
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Frequency, incidence rate, and severity of adverse events during the study period.
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From baseline through Week 12, and at the optional Week 24 follow-up visit.
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Hemorrhagic Complications
기간: From baseline through Week 12, and at the optional Week 24 follow-up visit.
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Presence or absence of hemorrhagic complications during the study period.
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From baseline through Week 12, and at the optional Week 24 follow-up visit.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Modified Rankin Scale (mRS)
기간: Baseline, Week 4 and Week 12
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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).
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Baseline, Week 4 and Week 12
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Fugl-Meyer Assessment (FMA)
기간: Baseline, Day 14, Week 4 and Week 12
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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.
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Baseline, Day 14, Week 4 and Week 12
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National Institutes of Health Stroke Scale (NIHSS)
기간: Baseline, Day 14 and Week 12
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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.
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Baseline, Day 14 and Week 12
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Maximum Muscle Strength
기간: Baseline, Day 7, Day 14, Day 21, Week 4, Week 8 and Week 12
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Maximum muscle strength will be assessed using the Mobie fixed-belt hand-held dynamometer.
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Baseline, Day 7, Day 14, Day 21, Week 4, Week 8 and Week 12
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Cerebral Infarct Volume on Magnetic Resonance Imaging (MRI)
기간: Baseline and Week 12 (±7 days)
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Change in cerebral infarct volume from baseline will be assessed using magnetic resonance imaging (MRI).
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Baseline and Week 12 (±7 days)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 9월 10일
기본 완료 (추정된)
2027년 9월 1일
연구 완료 (추정된)
2027년 12월 1일
연구 등록 날짜
최초 제출
2026년 9월 14일
QC 기준을 충족하는 최초 제출
2026년 9월 14일
처음 게시됨 (실제)
2026년 9월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 14일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- EFSA2026_01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
IPD 계획 설명
Once decided, only anonymized IPD may be shared with other collaborative stroke trials consortiums.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .