Taking people in United KingdomPhase 3
Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
Key facts
- Who runs it
- Vanda Pharmaceuticals
- Where
- Great Yarmouth, Leicester, Liverpool, London, and Sheffield, United KingdomSee the 5 sitesAlso in 3 other countries, 31 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 420 people, planned
- Started
- 21 Apr 2025
- Expected to end
- Jan 2028
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Tasimelteon Oral Suspension
- Placebo
- Record updated
- 5 June 2026
Who can take part
- Age
- 2 years to 17 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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?
Where in United Kingdom
Also in 3 other countries, 31 sites
- Great YarmouthHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
- LeicesterHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
- LiverpoolHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
- LondonHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
- SheffieldHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- TasimelteonTreatment being tested
Treatment: Tasimelteon Oral Suspension
- PlaceboPlacebo, for comparison
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 doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Multicenter, Double-Blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
- Fit questions
- Built from NCT06953869, who can take part
- Record updated
- 5 June 2026