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

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).

Timeline

Start

2024-09-15

Primary completion

2026-11-15

Completion

2027-06-01

Drugs

Indications