Avadel CLFT218-2401
A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of FT218 in the Treatment of Idiopathic Hypersomnia (IH) with an Open-Label Safety Extension
- Sex: Any
- Age: Adult (18 - 64), Older Adult (65+)
- Accepting Healthy People: No
- Type: Interventional / Therapeutic
- Trial Phase: Phase III
- Conditions Being Studied:
Study Purpose
The purpose of this research is to understand how well FT218 (study drug) works to reduce excessive daytime sleepiness in idiopathic hypersomnia (IH). This study will also evaluate the safety of the study drug.
Who Can Participate
Age: 18-75 years old
Locations
UH Beachwood Medical Center
25501 Chagrin Blvd.
Beachwood OH, 44122
UH Parma Medical Center
7007 Powers Boulevard
Parma OH, 44129
- UH IRB: STUDY20241246
- StudyID: 2024-01596
- ClinicalTrials.gov: N/A
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