Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia.
Status:
NOT_YET_RECRUITING
Trial end date:
2027-06-01
Target enrollment:
Participant gender:
Summary
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).