2026-525260-18-00招募中2 期
Open-label, single-center, single-arm phase 2 futility trial evaluating the oral indapamide for reducing progression of disability in people with primary and secondary progressive multiple sclerosis (MS)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Number of participants with PPMS and SPMS who experience significant (>= 20%) worsening in their T25FW performance at 12 months compared to a baseline measurement.
研究概览
简要总结
To demonstrate non-futility of indapamide treatment for the prevention of disability worsening in PPMS and SPMS
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained
- •Aged between 18 and 65 years
- •Diagnosed with PPMS or SPMS, according to current diagnostic criteria
- •Screening Expanded Disability Status Scale score between 4.0 and 6.5 inclusive
- •Screening timed 25 foot walk (average of two trials) of 5 seconds or more for people with PPMS, or of 9 seconds or more for people with SPMS
- •Use of effective methods of contraception for women of childbearing potential
排除标准
- •Individuals with renal insufficiency and an eGFR below 30ml/min per 1.73 m2
- •Individuals who start Baclofen or Tizanidine during the trial
- •Individuals who increase the dose of Baclofen or Tizanidine during the trial
- •Individuals who receive treatment with Botulinum toxin in the leg muscles during the trial
- •Individuals who use siponimod, ocrelizumab, natalizumab or other disease-modifying treatment for RRMS
- •Individuals with recent gadolinium enhancement or new T2 lesions on brain/spinal cord MRI in the 6 months prior to inclusion
- •Concomitant use of corticosteroids
- •Individuals with significant hepatic impairment (pre-existing or developing during the trial)
- •Individuals with clinically significant abnormal screening labs
- •Individuals with cardiac arrhythmia
- •Individuals with a prolonged QT interval: individuals with frequency corrected QT (QTc) intervals of more than 450ms (men) or 470ms (women) at the screening examination will not be included in the study, and participants with QTc intervals of greater than 500ms on any of the other ECG examinations throughout the study will be excluded from the study.
- •Individuals who are pregnant or currently breast-feeding
- •Individuals with an allergy or other intolerability to indapamide
- •Individuals who use Fampridine or 4-aminopyridine
- •Individuals who start Fampridine or 4-aminopyridine during the trial
结局指标
主要结局
Number of participants with PPMS and SPMS who experience significant (>= 20%) worsening in their T25FW performance at 12 months compared to a baseline measurement.
Number of participants with PPMS and SPMS who experience significant (>= 20%) worsening in their T25FW performance at 12 months compared to a baseline measurement.
次要结局
未报告次要终点
研究者
Wouter Meijer
Scientific
Amsterdam UMC Stichting
研究点 (1)
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