Back to resultsTrial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson's Disease (PD) (Xyrem)
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
sodium oxybate
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring excessive daytime somnolence, Parkinson disease, sleep disturbance
Eligibility 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 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 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Xyrem in Parkinson disease
Arm Description
sodium oxybate 4.5 to 9.0 gms per night
Outcomes
Primary Outcome Measures
Sleep and Fatigue
Sleep and Fatigue was measured using the following scales before and after sodium oxybate therapy Scales used to measure sleep and fatigue: Epworth Sleepiness Scale (ESS) where score ranges from 0-24 where 0 = no sleep problems and 24 = excessive sleep problems that should seek medical attention; Fatigue Severity Scale (FSS) where the score ranges from 9-36 where 9 = no fatigue and 36 = severe fatigue; Pittsburgh Sleep Quality Inventory (PSQI) where the score ranges from 0-21 where any score greater than 5 indicates a great sleep disturbance; 36-Item Short Form Health Survey (SF-36) where the score ranges 0-100 where 0 = the worst health status and 100 = the best health status. * Findings are reported for 28 subjects. The Full Range values reported reflect the measured minimum and maximum values.
Secondary Outcome Measures
Polysomnography (PSG)
Polysomnography, also called a sleep study, is a comprehensive test used to diagnose sleep disorders. The minimum score would be 0, the maximum score would be 30. A score of 0 - 4 = normal sleep, a score of 5 - 14 = a mild level of sleep disturbance, a score of 15 - 30 is moderate level of sleep disturbance and a score of 30 is severe sleep disturbance.
Full Information
NCT ID
NCT00641186
First Posted
March 18, 2008
Last Updated
September 28, 2022
Sponsor
Baylor College of Medicine
Collaborators
Jazz Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00641186
Brief Title
Trial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson's Disease (PD)
Acronym
Xyrem
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 Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
Jazz Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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 exclude subjects with sleepdisordered breathing. The following evening, subjects underwent another polysomnogram, followed by an evaluation with the Unified Parkinson Disease Rating Scale (UPDRS) while practically defined off ("off") PD medications, ESS (primary efficacy point), Pittsburgh Sleep Quality Inventory, and Fatigue Severity Scale. Subjects then started sodium oxybate therapy, which was titrated from 3 to 9 g per night in split doses (at bedtime and 4 hours later) across 6 weeks, and returned for subjective sleep assessments. They then returned at 12 weeks after initiating therapy for a third polysomnogram, an offmedication UPDRS evaluation, and subjective sleep assessments. Data are expressed as mean (SD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
excessive daytime somnolence, Parkinson disease, sleep disturbance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Xyrem in Parkinson disease
Arm Type
Experimental
Arm Description
sodium oxybate 4.5 to 9.0 gms per night
Intervention Type
Drug
Intervention Name(s)
sodium oxybate
Other Intervention Name(s)
Xyrem
Intervention Description
4.5 to 9.0 grams per night
Primary Outcome Measure Information:
Title
Sleep and Fatigue
Description
Sleep and Fatigue was measured using the following scales before and after sodium oxybate therapy Scales used to measure sleep and fatigue: Epworth Sleepiness Scale (ESS) where score ranges from 0-24 where 0 = no sleep problems and 24 = excessive sleep problems that should seek medical attention; Fatigue Severity Scale (FSS) where the score ranges from 9-36 where 9 = no fatigue and 36 = severe fatigue; Pittsburgh Sleep Quality Inventory (PSQI) where the score ranges from 0-21 where any score greater than 5 indicates a great sleep disturbance; 36-Item Short Form Health Survey (SF-36) where the score ranges 0-100 where 0 = the worst health status and 100 = the best health status. * Findings are reported for 28 subjects. The Full Range values reported reflect the measured minimum and maximum values.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Polysomnography (PSG)
Description
Polysomnography, also called a sleep study, is a comprehensive test used to diagnose sleep disorders. The minimum score would be 0, the maximum score would be 30. A score of 0 - 4 = normal sleep, a score of 5 - 14 = a mild level of sleep disturbance, a score of 15 - 30 is moderate level of sleep disturbance and a score of 30 is severe sleep disturbance.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William G Ondo, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
18852348
Citation
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. doi: 10.1001/archneur.65.10.1337.
Results Reference
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Trial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson's Disease (PD)
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