EUCTR2007-003512-57-FR进行中（未招募）1 期
Randomized, dose-finding study of BF 2.649 5, 10, 20 and 40 mg/d in comparison to placebo in Excessive Daytime Sleepiness in Parkinson’s Disease patients (PD)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bioprojet
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Adult outpatients of both sex with confirmed diagnosis of idiopathic PD defined by :
- •- UKPD Society Brain Bank clinical diagnostic criteria
- •- Historical knowledge of positive response to Levodopa or dopamine agonist test
- •- Severity of PD
- •- Hoehn and Yahr < 5
- •- Fluctuator and non fluctuator patients
- •- Stable treatment of PD for at least 4 weeks
- •- Excessive daytime sleepiness (EDS): Epworth scale superior or equal to 13
- •- Patients having accepted to participate in the study and signed the informed consent form
- •- Patient with health insurance
- •- Female patients with child-bearing potential using a medically accepted methof of birth control,agreeing to continue this method for the duration of the study and to be negative to serum pregnancy test performed at the screening visit
- •- Patients accepting and having sufficient support (in the opinion of the investigator) to comply with the study requirements (tests, self administered diaries completion, drug compliance, scheduled visits, car driving restriction if deemed necessary by the investigator…) and to maintain during the study their usual lifestyle (i.e. circadian rhythm, caffeine consumption, nocturnal sleep duration)
- •- None psychostimulant treatment intake for 2 weeks (at V2)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Other degenerative parkinsonian syndromes (supra nuclear paralysis, multisystemic atrophy, corticobasal degenerescence, diffuse Lewy’s Body dementia)
- •- Other condition than PD that can be considered the primary cause of excessive daytime sleepiness as:
- •Previous diagnostic of severe OSAS requiring CPAP according to the investigator
- •Idiopathic narcolepsy and narcolepsy secondary to structural brain lesion
- •Severe chronic alcohol consumption, shift work, chronic or occasional sleep deprivation,
- •- Severe depression (BDI = 16 ) or with suicidal risk (item G BDI > 0) or depression treated for less than 8 weeks
- •- Pregnant or breast-feeding women
- •- Patients having an occupation that requires night shift
- •- History of drugs, alcohol, narcotic or other substance abuse or dependence
- •- Refusal from the patient to stop any current therapy for excessive daytime sleepiness or predictable risks for the patient to stop the therapy
- •- Any significant abnormality in the physical examination or clinical laboratory results e.g. liver or kidney function deficiency,
- •- Any significant serious abnormality of the ECG e.g. recent myocardial infarction,
- •- Electrocardiogram Bazett’s corrected QT interval (QT x ?Racine carrée? [60/HR]) higher than 450 ms
- •- Other active clinically significant illness which could interfere with the study conduct or contra-indicate the study treatments or put patients at risk
- •- Dementia with MMS = 24
- •- Patients taking associated treatments which are not allowed during the study course and which cannot be stopped before the inclusion visit
研究者
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