2023-504278-39-00招募中2 期
Montelukast buccal film as disease modifying treatment in mild-moderate Parkinson’s disease (MONTPARK), a double-blind randomized placebo-controlled phase II trial
Karolinska University Hospital4 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2023年10月30日最近更新:
适应症
试验速览
- 阶段
- 2 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 outcome is the measurement of motor symptoms using the MDS-UPDRS Part 3, collected in the OFF-medication state at baseline, 6-, 12-, 18- and 21-month visits. The primary endpoint will be the model adjusted estimate for change in motor symptom score from baseline to month 18 across each group
研究概览
简要总结
The primary objective of the trial is to examine the effect of Montelukast on disease progression in early to moderate PD
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •The patient has given their written consent to participate in the trial
- •Diagnosis of PD
- •Males or Females
- •H&Y stage ≤ 2 in OFF
- •≥35 and ≤80 years of age
- •Clinical diagnosis < 4 years
- •Ongoing levodopa treatment
- •Ability to self-administer the trial drug
- •Female subjects 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. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post- menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
排除标准
- •Previous or concurrent depression requiring hospitalisation
- •Severe liver or renal disease
- •Concurrent moderate-to-severe depression, defined as MADRS > 20
- •Concurrent dementia, defined as MMSE < 22
- •Active oral mucosa inflammation
- •Active Hepatitis B or C infection
- •Any medical, psychiatric, or other condition which in the investigator’s opinion compromises the potential participant's ability to participate in the trial
- •Atypical or other causes of parkinsonism
- •Prior intra-cerebral surgical intervention
- •Already actively participating in a PD trial
- •Exposure to Montelukast in the last six months
结局指标
主要结局
The primary outcome is the measurement of motor symptoms using the MDS-UPDRS Part 3, collected in the OFF-medication state at baseline, 6-, 12-, 18- and 21-month visits. The primary endpoint will be the model adjusted estimate for change in motor symptom score from baseline to month 18 across each group
The primary outcome is the measurement of motor symptoms using the MDS-UPDRS Part 3, collected in the OFF-medication state at baseline, 6-, 12-, 18- and 21-month visits. The primary endpoint will be the model adjusted estimate for change in motor symptom score from baseline to month 18 across each group
次要结局
- MDS-NMS, HADS, evaluated at baseline, 6-, 12-, 18-, and 21-months visit.
- Adverse events, evaluated continuously
- LEDD score calculated at baseline and 18 months
研究者
Albert Hietala
Scientific
Karolinska University Hospital
研究点 (4)
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