this study evaluates of the efficacy of sodium oxybate on excessive daytime sleepiness using Epworth sleepiness scale over 8 weeks compared to placebo
Bicentric, randomized, double-blind controlled study Outpatients aged from 18 to 60 years, suffering from current idiopathic hypersomnia (ICSD-3), recruited via medical consultations in the investigation centers Randomization in Xyrem or placebo arms after the inclusion visit, 1.Screening Period (up to 15 days), 2.Titration Period (up to 45 days), 3.Maintenance Period (minimum 15 days), 4.Safety Follow-Up Period (14 days)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
48
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
Xyrem Placebo: sodium citrate solution in equimolar concentration of sodium in the 500 mg/mL Xyrem oral solution, PH adjusted with malic acid
University Hospital of Montpellier
Montpellier, France
Epworth Sleepiness Scale (ESS) score at the end-point visit
Evaluation of difference in sleepiness with ESS between the 2 groups. ESS scores range from 0 to 24; there is a risk of pathological daytime sleepiness if score is \> 10.
Time frame: over 8 weeks
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