2026-525906-37-00招募中3 期
Montelukast as disease modifying treatment in mild-moderate Parkinson’s disease, an open-label, phase II extension trial (MONTPARK_OLE)
Karolinska University Hospital4 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2026年8月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 98
- 试验地点
- 4
- 主要终点
- The primary endpoint is the rate and severity of AE including abnormal laboratory values. The rate will be compared to active and placebo arm of the original MONTPARK trial. AE will be documented at each visit but also continuously as needed.
研究概览
简要总结
The primary objective of this trial is to evaluate the long-term safety and tolerability of montelukast in PD patients during extended treatment.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •The subject has given their written consent to participate in the trial.
- •Successful completion of the MONTPARK trial
- •In the opinion of the investigator, PD diagnosis still valid and subject remains eligible for treatment.
- •Female participants must be 1 year post-menopausal** or be willing and able to use highly effective contraception during the treatment and up to 3 months after the last dose of IMP. Oral, injected, or implanted hormonal contraceptive, intrauterine device, intrauterine hormone-releasing system, surgical sterilization, transdermal delivery, congenital sterility, vasectomised partner or sexual abstinence are considered acceptable forms of birth control.
排除标准
- •Already actively participating in another PD trial apart from MONTPARK.
- •Severe liver or renal disease.
- •Active Hepatitis B or C infection
- •Concurrent moderate-to-severe depression, defined as HADS ≥
- •Concurrent dementia, defined as MoCA <
- •Any medical, psychiatric, or other condition which in the investigator’s opinion compromises the potential participant's ability to participate in the trial.
结局指标
主要结局
The primary endpoint is the rate and severity of AE including abnormal laboratory values. The rate will be compared to active and placebo arm of the original MONTPARK trial. AE will be documented at each visit but also continuously as needed.
The primary endpoint is the rate and severity of AE including abnormal laboratory values. The rate will be compared to active and placebo arm of the original MONTPARK trial. AE will be documented at each visit but also continuously as needed.
次要结局
- MDS-UPDRS Part 3
- MDS-UPDRS parts 1, 2 and 4
- Montreal Cognitive Assessment (MoCA)
- The Clinical Impression of Severity Index for Parkinson's Disease (CISI-PD)
- The Parkinson’s Disease Questionnaire (PDQ)-8
- Hospital Anxiety and Depression Scale (HAD)
- The Non-Motor Symptoms Questionnaire (NMSQ)
研究者
Albert Hietala
Scientific
Karolinska University Hospital
研究点 (4)
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