NCT03597555

Sodium Oxybate in Idiopathic Hypersomnia

A Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Tolerance of Sodium Oxybate in Patients Affected With Idiopathic Hypersomnia

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

this study evaluates of the efficacy of sodium oxybate on excessive daytime sleepiness using Epworth sleepiness scale over 8 weeks compared to placebo

Detailed description

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)

Conditions

• Idiopathic Hypersomnia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-10-18
• Primary completion: 2023-04-12
• Completion: 2023-04-12
• First posted: 2018-07-24
• Last updated: 2023-09-28

Locations

1 site across 1 country: France