Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
Key facts
- Where
- Cleveland, Columbia, Dothan, Great Falls, Houston, Irvine, Las Vegas, Lincoln, Miami, Miami Lakes, Myrtle Beach, Naperville, Nashville, Phoenix, Plano, San Antonio, Snellville, Stockbridge, Winter Park, and Worcester, United StatesSee the 20 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 United States
- Cleveland, OhioHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
- Columbia, South CarolinaHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
- Dothan, AlabamaHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
- Great Falls, MontanaHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
- Houston, TexasHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
- Irvine, CaliforniaHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
- Las Vegas, NevadaHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
- Lincoln, NebraskaHospital not named in the registryContact: Vanda Pharmaceuticals, Inc.No longer taking part
- Miami, FloridaHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
- Miami Lakes, FloridaHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
- Myrtle Beach, South CarolinaHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
- Naperville, IllinoisHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
- Nashville, TennesseeHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
- Phoenix, ArizonaHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
- Plano, TexasHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
- San Antonio, TexasHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
- Snellville, GeorgiaHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
- Stockbridge, GeorgiaHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
- Winter Park, FloridaHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
- Worcester, MassachusettsHospital not named in the registryContact: Vanda PharmaceuticalsTaking 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.