Sodium Oxybate in Idiopathic Hypersomnia

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

October 18, 2018

Primary Completion Date

April 12, 2023

Study Completion Date

April 12, 2023

Conditions
Idiopathic Hypersomnia
Interventions
DRUG

Sodium Oxybate Oral Solution 500 MG/ML

"First night after V1: Dose prescribed at 4.5 g per night (2.25 g x 2) for 2 weeks First night after V2: Dose increased to 6 g per night (3 g x 2) for 2 weeks, according to investigator's opinion, tolerance of drug and CGI-S First night after V3: Dose either maintained stable at 6 g or increased to 9 g per night (4.5 g x 2) with dose increments of 1.5 g per night (0.75 g x 2) every week, based on benefit-risk ratio, for 2 weeks.~First night after V4: Dose maintained at 9 g or reduced at 6 g per night according to benefit-risk ratio for 2 weeks. No dose adjustment during the Maintenance period.~First night after V5: Taper period. Dose decrease by 2.25 g x 2 every two days until complete withdrawal"

DRUG

Placebos

Xyrem Placebo: sodium citrate solution in equimolar concentration of sodium in the 500 mg/mL Xyrem oral solution, PH adjusted with malic acid

Trial Locations (1)

Unknown

University Hospital of Montpellier, Montpellier

All Listed Sponsors
lead

University Hospital, Montpellier

OTHER

NCT03597555 - Sodium Oxybate in Idiopathic Hypersomnia | Biotech Hunter | Biotech Hunter