A Prospective, Open Label, Single Arm, Clinical Study to Evaluate the Effect of Safinamide on Sleep Quality and Polysomnographic Parameters in Patients With Parkinson's Disease: the Safe Sleep Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Alain Kaelin
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Effect of safinamide on overall sleep quality
研究概览
简要总结
Patients suffering of Parkinson's Disease will be treated with 50 mg/day of Safinamide per os for 2 weeks (escalation phase). Then, safinamide will be increased up to 100 mg/day and, if tolerated, the treatment will be taken for 10 more weeks (maintenance phase). Total treatment 12 weeks.
详细描述
Adult patients affected by PD and suffering from motor fluctuations will be screened for participation.
If the inclusion and exclusion criteria are met, the participant will enter in the baseline assessment phase and undergo 1 night baseline PSG and 1 week baseline actigraphy. The patient will then start the treatment with 50 mg/day of Safinamide per os for 2 weeks (escalation phase). Then, safinamide will be increased up to 100 mg/day and, if tolerated, the treatment will last for 10 weeks (maintenance phase). At week 12 (end of treatment), the questionnaires, actigraphy and PSG will be repeated. A safety follow-up visit is scheduled 4 weeks after study treatment completion.
The treatment will be continued thereafter in all patients if medically indicated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Fluctuating idiopathic PD patients according to UK Brain bank Criteria
- •Hoehn and Year II to IV under treatment
- •Sleep disturbance with a Pittsburgh Sleep Quality Index (PSQI) > 5
- •Treatment with L-DOPA, alone or with other dopaminergic drugs, at a stable dose since at least 28 days prior to inclusion
- •Treatment with all substances potentially acting on sleep and mood must be constant since at least 28 days prior to inclusion
- •Written informed consent
- •Willingness and ability to participate in the trial
排除标准
- •Off label use of safinamide
- •Early PD or absence of PD fluctuations
- •Concomitant treatment with other MAO-B inhibitors (wash-out period: at least 14 days)
- •Atypical Parkinsonism
- •Severe known sleep-related breathing disorders with any specific treatment or severe known sleep-related breathing disorders (apnoea-hypopnea index score >30/h) with or without a specific treatment
- •Dementia (MoCA < 26)
- •Severe depression (BDI-II ≥ 29)
- •Other severe psychiatric symptoms such as active psychosis or major hallucinations
- •Any previous or concomitant severe medical conditions or clinical laboratory abnormality which, in the clinical judgement of the Investigators, does not allow patients' participation into the study
- •Moderate or severe hepatic impairment, any type of retinopathy and/or any pathology that is deemed to be a contraindication according to safinamide's SmPC
- •Any concomitant treatment not allowed or contraindicated in the safinamide SmPC
- •Women who are pregnant or breast feeding
- •Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
研究组 & 干预措施
Safinamide
PO treatment: 2 weeks of treatment at dose 50 mg/day followed by 10 weeks at 100 mg/day
干预措施: Safinamide (Drug)
结局指标
主要结局
Effect of safinamide on overall sleep quality
时间窗: 12 weeks
To measure the change in PDSS-2 (Parkinson's Disease Sleep Scale Version 2) score and the changes in sleep maintenance (=total sleep time/partial sleep time) and sleep efficiency (=total sleep time/ time in bed) scores measured by polysomnography (PSG). PDSS-2 total score ranges from 0 (no disturbance) to 60 (maximum nocturnal disturbance). Scores \> 18 are considered as relevant sleep disturbances.
次要结局
- Effect of safinamide on subjective motor activity(12 weeks)
- Effect of safinamide on quality of life(12 weeks)
- Effect of safinamide on subjective sleep quality and sleepiness(12 weeks)
- Effect of safinamide on objective PSG sleep characterization(12 weeks)
- Effect of safinamide on objective motor activity(12 weeks)
- Effect of safinamide on non-motor symptoms(12 weeks)
- Effect of safinamide on objective sleep parameters and motor symptoms(12 weeks)
研究者
Alain Kaelin
Director of Neurocenter of Southern Switzerland
Ente Ospedaliero Cantonale, Bellinzona