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Sponsors and Collaborators: |
Baylor College of Medicine Jazz Pharmaceuticals |
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Information provided by: | Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT00641186 |
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 |
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 |
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
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Drug: sodium oxybate
4.5 to 9.0 grams per night
|
Ages Eligible for Study: | 30 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
excessive daytime somnolence Parkinson disease sleep disturbance |
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 |
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 |