Phase II randomised, double-blind, placebo-controlled trial to assess the efficacy and safety of MLC1501 in patients with stroke: the MLC1501 study Assessing Efficacy in post-STrOke Subjects with mOtor deficits (MAESTOSO) study protocol.

IF 2.6 1区 医学
Christopher P L H Chen, Romulo U Esagunde, Cyrus G Escabillas, John Harold Hiyadan, Joel M Advincula, Christian Oliver C Co, Maria Epifania V Collantes, Annabelle Y Lao, Yeow-Hoay Koh, Deidre Anne De Silva, Carol Huilian Tham, Johnny K Lokin, Narayanaswamy Venketasubramanian
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引用次数: 0

Abstract

Background: MLC1501, consisting of four herbs, that is, Radix Astragali, Radix Angelicae sinensis, Rhizoma Chuanxiong, Radix Polygalae, has the same pharmacological properties as its precursors MLC601 and MLC901 which contain extracts of nine herbs and showed neuroprotective, anti-inflammatory and neurorestorative properties in non-clinical models, as well as clinical benefits in improving functional and neurological recovery after brain injuries.

Aims: To determine the efficacy of MLC1501 on motor recovery as measured by Fugl-Meyer motor Assessment (FMA) total score at 24 weeks in patients with ischaemic stroke (IS).

Design: A total of 300 patients aged >18 years, diagnosed with IS in the prior 2-10 days, with National Institute of Health Stroke Scale (NIHSS) total score of 8-18 and a combined score of ≥3 on NIHSS motor items 5A, 5B, 6A and/or 6B, will be randomised in a 1:1:1 ratio to receive oral placebo, MLC1501 low dose or MLC1501 high dose for 6 months. The study is governed by a Steering Committee. An independent Data Monitoring Committee oversees patient safety.

Outcomes: The primary outcome is mean change from baseline in FMA total score at 24 weeks. Efficacy outcomes evaluated in person at baseline, 12 weeks and 24 weeks include the FMA (total, upper extremity and lower extremity motor scores), modified Rankin Scale (mRS), Patient-Reported Outcomes Measurement Information System-Global Health (PROMIS-10) and NIHSS. Additionally, telephone assessment at week 4 includes the simplified mRS and PROMIS-10.Safety will be evaluated by standard assessments and occurrence of adverse events over the duration of the study.

Discussion: Interventions that enhance recovery beyond the acute period of stroke are needed. MLC1501 has a good safety profile as well as potential to be a treatment for recovery after brain injury. The results of this study will provide objective level B evidence on the efficacy of MLC1501 on long-term recovery and safety of 24 weeks of treatment among patients with IS.

Trial registration number: NCT05289947.

评估MLC1501在卒中患者中的疗效和安全性的II期随机、双盲、安慰剂对照试验:MLC1501研究评估卒中后运动缺陷受试者的疗效(MAESTOSO)研究方案。
背景:MLC1501由黄芪、当归、川芎、多倍子四种中药组成,其药理特性与其前体MLC601和MLC901(含九种中药提取物)相同,在非临床模型中表现出神经保护、抗炎和神经恢复的特性,并在改善脑损伤后功能和神经恢复方面具有临床益处。目的:探讨MLC1501对缺血性脑卒中(IS)患者24周Fugl-Meyer运动评估(FMA)总分运动恢复的疗效。设计:共有300名年龄在bb0 -18岁,在前2-10天诊断为IS的患者,NIHSS总分为8-18分,NIHSS运动项目5A、5B、6A和/或6B的综合评分≥3分,按1:1:1的比例随机分配,接受口服安慰剂,MLC1501低剂量或MLC1501高剂量,为期6个月。这项研究由指导委员会管理。一个独立的数据监测委员会监督患者的安全。结果:主要结果是24周时FMA总分较基线的平均变化。在基线、12周和24周亲自评估的疗效结果包括FMA(总、上肢和下肢运动评分)、改良Rankin量表(mRS)、患者报告的结果测量信息系统-全球健康(允诺-10)和NIHSS。此外,第4周的电话评估包括简化的mRS和promise -10。安全性将通过标准评估和研究期间不良事件的发生来评估。讨论:干预措施,提高恢复超过急性期卒中是必要的。MLC1501具有良好的安全性以及作为脑损伤后康复治疗的潜力。本研究结果将为MLC1501对IS患者长期康复的疗效和24周治疗的安全性提供客观的B级证据。试验注册号:NCT05289947。
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来源期刊
Journal of Investigative Medicine
Journal of Investigative Medicine MEDICINE, GENERAL & INTERNALMEDICINE, RESE-MEDICINE, RESEARCH & EXPERIMENTAL
自引率
0.00%
发文量
111
期刊介绍: Journal of Investigative Medicine (JIM) is the official publication of the American Federation for Medical Research. The journal is peer-reviewed and publishes high-quality original articles and reviews in the areas of basic, clinical, and translational medical research. JIM publishes on all topics and specialty areas that are critical to the conduct of the entire spectrum of biomedical research: from the translation of clinical observations at the bedside, to basic and animal research to clinical research and the implementation of innovative medical care.
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