NCT05056194撤回2 期
A Double-blind, Randomized, Placebo-controlled, Parallel, Study to Assess the Efficacy and Safety of XW10172 MR for the Treatment of Excessive Daytime Sleepiness in Patients with Parkinson's Disease
XWPharma0 个研究点目标入组 70 人开始时间: 2021年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 70
- 主要终点
- Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Epworth Sleepiness Scale.
研究概览
简要总结
Following screening visit and verification of inclusion/exclusion criteria and informed consent, participants will undergo a multiple sleep latency test (MSLT) and polysomnogram (PSG) assessments to confirm eligibility for randomization. Participants will be randomized to two groups: placebo or XW10172 MR. The drug will be taken orally at bedtime for 6 weeks of treatment that will consist of a 2-week dose escalation/titration period and a 4-week stable-dose maintenance period. There will be a 2-week safety period following dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson's disease consistent with the UK-PD Society Brain Bank Criteria and PD duration at least 1 year with modified Hoehn and Yahr stage 1-3 in the OFF state.
- •Patient reported history of excessive daytime sleepiness (e.g., frequent dozing, nodding, or naps).
- •Anti-Parkinson's medications at stable doses for at least 1 month prior to the Baseline Visit and can maintain a fixed, stable dose throughout the study
- •Epworth Sleepiness Scale score of >10 at screening.
- •Female participants of childbearing potential must test negative in a serum pregnancy test at Screening and have a negative urine pregnancy test at the Baseline and Visit. Women with childbearing potential must use an acceptable method of contraception during the study and for at least 30 days after completion of dosing.
排除标准
- •Atypical or secondary parkinsonism
- •Significant medical conditions.
- •Evidence of moderate or severe sleep disordered breathing.
- •Drugs that affect sleep including CNS depressants and stimulants.
- •Montreal Cognitive Assessment (MoCA) examine score <
- •Hospital Anxiety and Depression Scales (HADS) >
- •Have an occupation that requires variable shift work or routine night shifts or travel across two or more-time zones.
研究组 & 干预措施
Valiloxybate
Experimental
XW10172 Modified Release (MR) Granules for Oral Suspension
干预措施: Valiloxybate (Drug)
Placebo
Placebo Comparator
Placebo Granules for Oral Suspension
干预措施: Placebo (Other)
结局指标
主要结局
Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Epworth Sleepiness Scale.
时间窗: 6 weeks
次要结局
- Difference between XW10172 and placebo in the change from baseline to end-of-maintenance in the Caregiver Global Impression of Change.(6 weeks)
- Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Multiple Sleep Latency Test(6 weeks)
- Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Parkinson's Fatigue Scale 16.(6 weeks)
- Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Brief Assessment of Cognition composite score(6 weeks)
研究者
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