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Sodium Oxybate in Idiopathic Hypersomnia — SODHI  

Idiopathic Hypersomnia Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03597555
Study type Interventional
Source University Hospital, Montpellier
Contact
Status Completed
Phase Phase 2/Phase 3
Start date October 18, 2018
Completion date April 12, 2023
View Details
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