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

Condition(s) targeted: Parkinson Disease

Intervention: sodium oxybate (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Baylor College of Medicine

Official(s) and/or principal investigator(s):
William G Ondo, MD, Principal Investigator, Affiliation: Baylor College of Medicine

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).

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

Primary outcome:

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

To evaluate the possible efficacy of Xyrem in the treatment of the sleep disturbances and EDS common in Parkinsonian patients.

Secondary outcome: To determine if Xyrem treatment improves daytime motor symptoms and the overall quality of life in patients with mild to moderate PD.

Minimum age: 30 Years. Maximum age: 75 Years. Gender(s): Both.

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.

Starting date: September 2004
Ending date: November 2008
Last updated: March 21, 2008