NeuroAiD Patient-Reported Outcomes in Patients With Mild to Moderate Ischemic Stroke (NAiD-PRO)
2026年9月14日 更新者：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.
調査の概要
状態
募集
詳細な説明
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.
研究の種類
介入
入学 (推定)
80
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Ho Chi Minh City、ベトナム
- 募集
- Traditional Medicine Institute
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コンタクト：
- Thi Lan Huong Dinh, MD
- 電話番号：+84 983 699 665
- メール：dinhlanhuonghmu@gmail.com
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コンタクト：
- Thanh Tuyen Nguyen
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主任研究者：
- Nguyen Hao Nhien Le
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副調査官：
- Le Anh Trung Nguyen
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副調査官：
- Tri Cuong Nguyen
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副調査官：
- Thi My Phuong Ho
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副調査官：
- Dinh Hung Nguyen
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副調査官：
- Thi Phuoc Hoa Ta
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副調査官：
- Ngoc Ha Phuong Dang
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副調査官：
- Le Bao Quyen Nguyen
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主任研究者：
- Thi Lan Huong Dinh
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
他の名前：
Participants will receive standard treatment for acute ischemic stroke according to the study protocol for 12 weeks
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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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EuroQol 5-Dimension 5-Level (EQ-5D-5L)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Modified Rankin Scale (mRS)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年9月10日
一次修了 (推定)
2027年9月1日
研究の完了 (推定)
2027年12月1日
試験登録日
最初に提出
2026年9月14日
QC基準を満たした最初の提出物
2026年9月14日
最初の投稿 (実際)
2026年9月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月18日
QC基準を満たした最後の更新が送信されました
2026年9月14日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- EFSA2026_01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
IPD プランの説明
Once decided, only anonymized IPD may be shared with other collaborative stroke trials consortiums.
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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