Trial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson's Disease (PD) (NCT00641186) | Clinical Trial Compass
CompletedPhase 2
Trial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson's Disease (PD)
30 participantsStarted 2004-09
Plain-language summary
This clinical trial is designed to evaluate the safety and potential efficacy of Xyrem for the treatment of excessive daytime sleepiness (EDS) and nocturnal sleep disturbance in patients with mild to moderate Parkinson's Disease (PD).
Who can participate
Age range30 Years – 75 Years
SexALL
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Inclusion Criteria:
* Male or female with a diagnosis of idiopathic PD.
* Age between 30 and 75, inclusive. -Hoehn \& Yahr Stage 1.5 - 4.0 in the practically defined medication "OFF". -
* History \> 2 months of excessive daytime sleepiness confirmed at baseline/screening by an Epworth Sleepiness Scale score of \> 10.
* History \> 2 months of nocturnal sleep disturbances consisting of insomnia, fragmented sleep and/or non-restorative sleep.
* Folstein Mini-Mental State Exam score of \> 24.
* Birth control for sexually active women of childbearing potential (e.g. abstinence, hormonal contraception, barrier method, intrauterine device).
* Evidence of a personally signed and dated informed consent form document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
* Stable dose of medications, defined as no change in dose or regimen of medications for at least 3 months prior to Screen Visit.
Exclusion Criteria:
* Known idiopathic sleep pathology: sleep apnea and narcolepsy.
* Serious co-morbid disease --Atypical parkinsonism (e.g., Parkinson "plus" syndrome, secondary Parkinson's syndrome). --Significant neurological symptoms not accounted for by PD. --Significant psychiatric symptoms or dementia.
* Sexually active women of childbearing potential without adequate form of birth control.
* Pregnan…