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Avadel CLFT218-2401

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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: Idiopathic Hypersomnia

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

Principal Investigator
Sally Ibrahim MD

Department/Division
Pediatrics (Pulmonology)

Locations

UH Cleveland Medical Center
11100 Euclid Ave
Cleveland OH, 44106

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UH Beachwood Medical Center
25501 Chagrin Blvd
Beachwood OH, 44122

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UH Parma Medical Center
7007 Powers Blvd
Parma OH, 44129

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UH IRB: STUDY20241246
StudyID: 2024-01596
ClinicalTrials.gov: N/A

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