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

NCT00641186 | Completed Phase 2 Results

• 1 other identifier: H-16378
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Parkinson Disease

Keywords

excessive daytime somnolence; Parkinson disease; sleep disturbance

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (1)

• Polysomnography (PSG)

  8 weeks

Study Arms (1)

Xyrem in Parkinson disease

EXPERIMENTAL

sodium oxybate 4.5 to 9.0 gms per night

Drug: sodium oxybate

Interventions

sodium oxybate DRUG

4.5 to 9.0 grams per night

Also known as: Xyrem

Xyrem in Parkinson disease

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Jazz Pharmaceuticals: collaborator

Related Publications (1)

• 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.

  PMID: 18852348 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Disorders of Excessive Somnolence; Parasomnias

Interventions

Sodium Oxybate

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Hydroxybutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids

Results Point of Contact

• Title: Christine Hunter
• Organization: Baylor College of Medicine

chunter@bcm.edu

713-798-3951

Study Officials

• William G Ondo, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 18, 2008
• First Posted: March 24, 2008
• Study Start: September 1, 2004
• Primary Completion: July 1, 2008
• Study Completion: November 1, 2008
• Last Updated: October 6, 2022
• Results First Posted: September 28, 2022

Record last verified: 2022-09