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Trial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson's Disease (PD) (Xyrem)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00641186
Recruitment Status : Completed
First Posted : March 24, 2008
Last Update Posted : May 1, 2009
Jazz Pharmaceuticals
Information provided by:
Baylor College of Medicine

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 moderate Parkinson's Disease (PD).

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: sodium oxybate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2004
Actual Primary Completion Date : July 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A
sodium oxybate 4.5 to 9.0 gms per night
Drug: sodium oxybate
4.5 to 9.0 grams per night
Other Name: Xyrem

Primary Outcome Measures :
  1. 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 ]
  2. To evaluate the possible efficacy of Xyrem in the treatment of the sleep disturbances and EDS common in Parkinsonian patients. [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 "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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00641186

Sponsors and Collaborators
Baylor College of Medicine
Jazz Pharmaceuticals
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Principal Investigator: William G Ondo, MD Baylor College of Medicine
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: William G. Ondo, MD, Baylor College of Medicine Identifier: NCT00641186    
Other Study ID Numbers: H-16378
First Posted: March 24, 2008    Key Record Dates
Last Update Posted: May 1, 2009
Last Verified: April 2009
Keywords provided by Baylor College of Medicine:
excessive daytime somnolence
Parkinson disease
sleep disturbance
Additional relevant MeSH terms:
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Parkinson Disease
Disorders of Excessive Somnolence
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Sleep Wake Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Sodium Oxybate
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs