Status:
COMPLETED
Trial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson's Disease (PD)
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Jazz Pharmaceuticals
Conditions:
Parkinson Disease
Eligibility:
All Genders
30-75 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Inclusion required an Epworth Sleepiness Scale (ESS) score greater than 10 and any subjective nocturnal sleep concern, usually insomnia. An acclimation and screening polysomnogram was performed to exc...
Eligibility Criteria
Inclusion
- 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
- 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.
- Pregnancy or lactation.
- Mini-mental status examination of \< 25.
- Participation in another clinical trial of another investigational agent or device within the previous 60 days.
- Current abuse of alcohol or drugs.
- Active or prior malignancy other than cutaneous basal cell carcinoma or in situ carcinoma of the uterine cervix.
- Known hypersensitivity to sodium oxybate or other constituents of the product.
- Any medical conditions that are contraindications to the use of sodium oxybate or significant hepatic impairment.
- Patients being treated with sedative hypnotic agents or other central nervous system (CNS) depressants.
- Subjects taking warfarin.
- Patients with succinic semialdehyde dehydrogenase deficiency.
- Subjects who, in the opinion of the investigator, are not able to comply with the requirements of the study.
- Any other condition that, in the investigator's opinion, would cause a significant hazard to the subject.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00641186
Start Date
September 1 2004
End Date
November 1 2008
Last Update
October 6 2022
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