At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Tasimelteon Oral Suspension (drug), Placebo (drug)
- How long the study runs
- Study runs about 33 months (dates as stated)
- About the drug or intervention
- Tasimelteon Oral Suspension — drug: Single daily dose, weight-based liquid suspension formulation. · Placebo — drug: Placebo comparator.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is looking at whether a medicine called tasimelteon helps children and young people aged 2 to 17 who have been diagnosed with insomnia disorder (ongoing trouble sleeping). Tasimelteon will be compared with a placebo, which is a dummy medicine with no active drug in it. The study is funded by Vanda Pharmaceuticals.
Who can take part
- Aged between 2 and 17 years old
- Males and females can take part
- A confirmed diagnosis of insomnia disorder from a doctor
- The sleep problem must not be caused by another medicine
- The participant, parent, or legal guardian must agree in writing for the child to take part (with the child's agreement where needed)
Who may not be able to
- Cannot take tasimelteon daily, or has had a bad reaction to tasimelteon before
- Signs that the liver is not working properly
- Females who are pregnant or breastfeeding
- A positive test for drugs of abuse
What taking part involves
- • Taking tasimelteon or a placebo (a dummy medicine with no active drug) daily
- • Being checked against the study's inclusion and exclusion rules to confirm you can take part
Time commitment: Not stated — ask the trial team (the data does not say how long the study lasts, how many visits are needed, or what tests are involved).
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 2 Years to 17 Years
- Who
- All
- Number of participants
- 420
- Started
- 2025-04-21
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for insomnia disorder
- • Phase3 - 420 participants
- • 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
Who can take part?
- • Ages 2 Years to 17 Years
- • Diagnosed with insomnia disorder
Where?
- • Great Yarmouth - Vanda Investigational Site
- • Leicester - Vanda Investigational Site
- • Liverpool - Vanda Investigational Site
- • London - Vanda Investigational Site
- • +3 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 2 Years - 17 Years
- Who can join: All genders
What the study is looking for
- ✓Ability and acceptance to provide written agreement to take part of the participant or legal guardian (and assent as...
- ✓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.
- ✗Indication of impaired liver function.
- ✗Pregnant or lactating females.
- ✗A positive test for drugs of abuse.
See the full criteria
Where Is This Study? (7 UK sites)
Vanda Investigational Site
Great Yarmouth NR31 6LA, United Kingdom
Vanda Investigational Site
Leicester LE1 5WW, United Kingdom
Vanda Investigational Site
Liverpool L12 2AP, United Kingdom
Vanda Investigational Site
London E1 1FR, United Kingdom
Vanda Investigational Site
London SE1 7EH, United Kingdom
Vanda Investigational Site
London SE6 4LF, United Kingdom
Vanda Investigational Site
Sheffield S10 2TH, United Kingdom
How to Get in Touch
Vanda Pharmaceuticals, Inc.
Sponsor contactCONTACT