Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
Key facts
- Where
- Berlin, Leipzig, and Munich, GermanySee the 3 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 17 years old?
Source: NCT06953869, who can take part
Where in Germany
- Advanced Sleep Research GmbHBerlin, GermanyTaking people
- Velocity Clinical Research Germany GmbHLeipzig, GermanyTaking people
- ProSomno GmbHMunich, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Vanda Pharmaceuticals
- Trial code
- NCT06953869EU 2024-516411-24-00
- Record updated
- 5 June 2026
- Original description
This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female pediatric participants with insomnia disorder.Read full original descriptionShow less
A Multicenter, Double-Blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female pediatric participants with insomnia disorder.
Inclusion: Ability and acceptance to provide written informed consent of the participant or legal guardian (and assent as required); Confirmed clinical diagnosis of insomnia disorder; Males and Females between 2 and 17 years, inclusive; The sleep disturbance must not be a result of another medication.
Exclusion: Inability to dose daily with tasimelteon or previous intolerance to tasimelteon; A positive test for drugs of abuse; Indication of impaired liver function; Pregnant or lactating females.