Parkinson DiseasePhase 2XyremNCT00641186
Trial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson's Disease (PD)
A Phase 2 study testing sodium oxybate in people with Parkinson Disease, run by Baylor College of Medicine.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- sodium oxybate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2004to Nov 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
About this 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
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).
Read the 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).
- Conditions
- Parkinson Disease
- Being tested
- sodium oxybate
- Keywords
- excessive daytime somnolence, Parkinson disease, sleep disturbance
- Medical subject headings
- Parkinson Disease, Disorders of Excessive Somnolence, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium oxybateDrug
Also called Xyrem
4.5 to 9.0 grams per night
| Study group | Role | What they receive |
|---|---|---|
| Xyrem in Parkinson disease | Experimental | sodium oxybate 4.5 to 9.0 gms per night Receives: Drug: sodium oxybate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (1)
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startSep 2004
- Primary completionJul 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Jazz Pharmaceuticals
- Responsible party
- Principal investigator, Joseph Jankovic, Baylor College of Medicine
- Investigators
- William G Ondo, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641186
- Sponsor's protocol ID
- H-16378
- Acronym
- Xyrem
- Status last verified
- Sep 2022
- First submitted
- 18 Mar 2008
- Last updated
- 6 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 18852348
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00641186
- Acronym / sponsor ID
- Xyrem / H-16378
- Conditions
- Parkinson Disease
- Keywords
- excessive daytime somnolence, Parkinson disease, sleep disturbance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Jazz Pharmaceuticals
- Study start
- Sep 2004
- Primary completion
- Jul 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 24 Mar 2008 (estimated)
- Results
- Posted 28 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xyrem in Parkinson disease | Experimental | Drug: sodium oxybatesodium oxybate 4.5 to 9.0 gms per night |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sodium oxybateAlso: Xyrem4.5 to 9.0 grams per night | Drug | Xyrem in Parkinson disease |
Primary outcome
Sleep and Fatigue
Time frame: 8 weeks
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.
1 secondary outcome
Polysomnography (PSG)
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18852348Ondo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William G Ondo, MD principal investigator
Baylor College of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sodium oxybate in people with Parkinson Disease, run by Baylor College of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep and Fatigue (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00641186, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.