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

Sponsors and Collaborators:	Baylor College of Medicine Jazz Pharmaceuticals
Information provided by:	Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00641186

Purpose

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	Intervention
Parkinson Disease	Drug: sodium oxybate

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Club Drugs Dietary Sodium Parkinson's Disease Sleep Disorders

Drug Information available for: Sodium oxybate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Baylor College of Medicine:

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:	30
Study Start Date:	September 2004
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental sodium oxybate 4.5 to 9.0 gms per night	Drug: sodium oxybate 4.5 to 9.0 grams per night

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641186

Sponsors and Collaborators

Baylor College of Medicine

Jazz Pharmaceuticals

Investigators

Principal Investigator:

William G Ondo, MD

Baylor College of Medicine

More Information

Publications indexed to this study:

Ondo WG, Perkins T, Swick T, Hull KL Jr, Jimenez JE, Garris TS, Pardi D. Sodium oxybate for excessive daytime sleepiness in Parkinson disease: an open-label polysomnographic study. Arch Neurol. 2008 Oct;65(10):1337-40.

Responsible Party:	Baylor College of Medicine ( William G. Ondo, MD )
Study ID Numbers:	H-16378
Study First Received:	March 18, 2008
Last Updated:	March 21, 2008
ClinicalTrials.gov Identifier:	NCT00641186
Health Authority:	United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:

excessive daytime somnolence
Parkinson disease
sleep disturbance

Study placed in the following topic categories:

Ganglion Cysts
Basal Ganglia Diseases
Sleep Disorders
Dyssomnias
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases

Signs and Symptoms
Parkinson Disease
Movement Disorders
Mental Disorders
Neurologic Manifestations
Parkinsonian Disorders
Sodium Oxybate

Additional relevant MeSH terms:

Anesthetics, Intravenous
Adjuvants, Anesthesia
Anesthetics, General
Therapeutic Uses
Physiological Effects of Drugs

Nervous System Diseases
Central Nervous System Depressants
Anesthetics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009