A randomised study investigating the use of tasimelteon in the treatment of paediatric insomnia
Research type
Research Study
Full title
A multicenter, double-blind, randomized study to evaluate the effects of tasimelteon vs. placebo in treating pediatric insomnia
IRAS ID
1011088
Contact name
Christos Polymeropoulos
Contact email
Sponsor organisation
Vanda Pharmaceuticals, Ltd.
Eudract number
2024-516411-24
Research summary
One of the most commonly reported sleep problems in children is difficulty getting to sleep. Around 1/3 caregivers have reported that their child had problems going to sleep at night and staying asleep throughout the night. The purpose of the study is to determine if a drug called tasimelteon, when taken daily at bedtime, can help improve nighttime sleep in children with insomnia. Tasimelteon is approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for other sleep disorders. Participtant will be asked to visit the study site 5 times over the 13-month study. Also they will be asked to complete a daily online sleep diary every morning and evening and wear an actigpraphy watch for the entire study.
The purpose of the study is to determine if tasimelteon, when taken daily at bedtime, can help improve nighttime sleep in children with insomnia. To test this, we will recruit 420 children and teenagers, aged from 2 to 17 years with insomnia, for this study study.
This study has 3 phases: 1. The Screening Phase, 2. The Treatment Phase, 3. The Open-Label Extension Phase. Participants will go through a Screening Phase to record their insomnia before treatment begins. During the Treatment Phase, participants will be randomly assigned to receive either tasimelteon or placebo. This means they will not know if you are given tasimelteon or a placebo alternative. Each participant will have an equal chance (50%) of receiving tasimelteon or placebo. After the randomized treatment phase, participants can continue in the study with a 100% chance of receiving active tasimelteon in the Open-Label Extension Phase. The study will last 13 months and subjects will be asked to visit the clinical study site 5 times. Additionally, they will be asked to take the study drug every day, complete a daily diary about how they are sleeping, and wear an activity watch.
This is a global study with clinical sites across the UK, Europe and the United States.REC name
West of Scotland REC 1
REC reference
25/WS/0062
Date of REC Opinion
13 Jan 2026
REC opinion
Further Information Favourable Opinion