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REVITALYZ Study for Idiopathic Hypersomnia

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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

Participants 18 years and older who are diagnosed with idiopathic hypersomnia may be eligible for this study.

Principal Investigator
Sally Ibrahim MD
Department/Division
Pediatrics (Pulmonology)

Locations

UH Cleveland Medical Center
11100 Euclid Ave
Cleveland OH, 44106

UH Beachwood Medical Center
25501 Chagrin Blvd
Beachwood OH, 44122

UH Parma Medical Center
7007 Powers Blvd
Parma OH, 44129

  • UH IRB: STUDY20241246
  • StudyID: 2024-01596
  • ClinicalTrials.gov: NCT06525077
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