Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia.

This Phase II clinical trial is a monocenter, double-blind, randomized, placebo-controlled study aimed at evaluate the efficacy and safety of solriamfetol from 75 to 300 mg per day in IH patients. Patients will be randomized (1:1) to receive either solriamfetol or placebo, with titration, every morning upon awakening during all treatment periods (Day 0 to Week 7).

NCT Number	NCT06590662
Lead Sponsor	University Hospital, Montpellier
Conditions	Idiopathic Hypersomnia
Enrollment	60 participants
Start Date	2024-09-15
Primary Completion	2026-11-15 (estimated)
Study Completion	2027-06-01 (estimated)
Updated on ClinicalTrials.gov	2024-09-19