Trial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson's Disease (PD)
This study has been completed.
Information provided by:
Baylor College of Medicine
First received: March 18, 2008
Last updated: April 30, 2009
Last verified: April 2009
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).
Drug: sodium oxybate
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase II, Eight Week, Multi-Center, Open Label Trial of Xyrem(R) (Sodium Oxybate) for Excessive Daytime Sleepiness and Nocturnal Sleep Disturbance in Patients With Mild to Moderate Parkinson's Disease
Primary Outcome Measures:
- To evaluate the safety and tolerability of Xyrem (sodium oxybate) oral solution at nightly doses of 4.5 to 9.0 grams in patients with Parkinson's Disease [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- To evaluate the possible efficacy of Xyrem in the treatment of the sleep disturbances and EDS common in Parkinsonian patients. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To determine if Xyrem treatment improves daytime motor symptoms and the overall quality of life in patients with mild to moderate PD. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2008 (Final data collection date for primary outcome measure)
sodium oxybate 4.5 to 9.0 gms per night
Drug: sodium oxybate
4.5 to 9.0 grams per night
Other Name: Xyrem
|Ages Eligible for Study:
||30 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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 "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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00641186
Baylor College of Medicine
||William G Ondo, MD
||Baylor College of Medicine
No publications provided by Baylor College of Medicine
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
||William G. Ondo, MD, Baylor College of Medicine
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 18, 2008
||April 30, 2009
||United States: Institutional Review Board
Keywords provided by Baylor College of Medicine:
excessive daytime somnolence
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013
Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms
Central Nervous System Agents
Central Nervous System Depressants
Physiological Effects of Drugs