Use of Xyrem to Improve Sleep in Chronic Fatigue Syndrome

PHASE4TerminatedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

May 31, 2007

Primary Completion Date

December 31, 2008

Study Completion Date

December 31, 2008

Conditions
Chronic Fatigue Syndrome
Interventions
DRUG

Placebo

Subjects will be randomly assigned to either placebo or drug. The medication and the placebo come as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predetermined maximum is reached.

DRUG

Sodium Oxybate

Subjects will be randomly assigned to either placebo or drug. The medication and the placebo come as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predetermined maximum is reached.

Trial Locations (1)

07101

UMDNJ - Pain & Fatigue Study Center, ADMC 1618, Newark

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Jazz Pharmaceuticals

INDUSTRY

lead

University of Medicine and Dentistry of New Jersey

OTHER