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A MULTICENTER, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFECTS OF TASIMELTEON VS. PLACEBO IN TREATING PEDIATRIC INSOMNIA

Sex: Any
Age: Child (Birth - 17)
Accepting Healthy People: No
Type: Interventional / Therapeutic
Trial Phase: Phase III
Conditions Being Studied:

Study Purpose

The purpose of this research study is to investigate a potential treatment to address sleep difficulties in children with insomnia disorder. This study is being conducted to determine if tasimelteon, when taken daily at bedtime, can help improve nighttime sleep in children with insomnia disorder. This study may also help researchers learn more about the safety of tasimelteon.

Who Can Participate

Ages: 2-17 years old

Principal Investigator
Sally Ibrahim MD

Department/Division
Pediatrics (Pulmonology)

Locations

UH Beachwood Medical Center
25501 Chagrin Blvd.
Beachwood OH, 44122

UH Cleveland Medical Center
11100 Euclid Avenue
Cleveland OH, 44106

UH Parma Medical Center
7007 Powers Boulevard
Parma OH, 44129

UH IRB: STUDY20241215
StudyID: 2024-01589
ClinicalTrials.gov: N/A

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