Sodium Oxybate in Patients With Chronic Fatigue Syndrome.

PHASE4WithdrawnINTERVENTIONAL
0
Timeline

Start Date

June 30, 2013

Primary Completion Date

June 30, 2015

Study Completion Date

December 31, 2015

Conditions
Chronic Fatigue Syndrome
Interventions
DRUG

Sodium oxybate

Treatment is started and continued for 6 weeks at patient's home. Patients receive 3g/night during the first week, and 4,5 g/night during the second week. After the second week, patients have their dose increased to 6 g/night during 6 weeks. A washout period of 4 weeks is installed to withdraw from treatment. Patients receive 4,5 g/night for 1 week, followed by 3g/night for 1 week. The next 2 weeks, patients are not treated.

DRUG

Placebo

Placebo treatment is started and continued for 6 weeks at patient's home. Patients receive 3 g/night during the first week and 4.5 g/night during the second week. After the second week, patients have their dose increased to 6 g/night during 6 weeks. A washout period of 4 weeks is installed to withdraw from treatment. Patients receive 4.5 g/night for 1 week, followed by 3 g/night for 1 week. The next 2 weeks, patients are not treated.

Trial Locations (1)

9000

Ghent University Hospital, Ghent

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

UCB Pharma

INDUSTRY

lead

University Hospital, Ghent

OTHER