Insomnia DisorderPhase 3NCT06953869
Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
A Phase 3 study testing Tasimelteon Oral Suspension in people with Insomnia Disorder, run by Vanda Pharmaceuticals at 35 sites in 4 countries.
Trial summary
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 more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Insomnia Disorder
- What is being tested?
- Tasimelteon Oral Suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 35 sitesin 4 countries
- Study dates
- 21 Apr 2025to Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
35 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
35 sites in 4 countries
United States21 sites, 20 recruiting
- Recruiting
Vanda Investigational Site
Cleveland, Ohio, 11100
Vanda Pharmaceuticals
- Recruiting
Vanda Investigational Site
Columbia, South Carolina, 29201
Vanda Pharmaceuticals
- Recruiting
Vanda Investigational Site
Dothan, Alabama, 36303
Vanda Pharmaceuticals
- Recruiting
Vanda Investigational Site
Great Falls, Montana, 59405
Vanda Pharmaceuticals
- Recruiting
Vanda Investigational Site
Houston, Texas, 77030
Vanda Pharmaceuticals
- Recruiting
Vanda Investigational Site
Irvine, California, 92614
Vanda Pharmaceuticals
- Recruiting
Vanda Investigational Site
Las Vegas, Nevada, 89128
Vanda Pharmaceuticals
- Active, not recruiting
Vanda Investigational Site
Lincoln, Nebraska, 68526
- Recruiting
Vanda Investigational Site
Miami, Florida, 33155
Vanda Pharmaceuticals
- Recruiting
Vanda Investigational Site
Miami Lakes, Florida, 33016
Vanda Pharmaceuticals
- Recruiting
Vanda Investigational Site
Myrtle Beach, South Carolina, 29582
Vanda Pharmaceuticals
- Recruiting
Vanda Investigational Site
Naperville, Illinois, 60563
Vanda Pharmaceuticals
- Recruiting
Vanda Investigational Site
Nashville, Tennessee, 37232
Vanda Pharmaceuticals
- Recruiting
Vanda Investigational Site
Phoenix, Arizona, 85006
Vanda Pharmaceuticals
- Recruiting
Vanda Investigational Site
Plano, Texas, 75075
Vanda Pharmaceuticals
- Recruiting
Vanda Investigational Site
San Antonio, Texas, 78229
Vanda Pharmaceuticals
- Recruiting
Vanda Investigational Site
San Antonio, Texas, 78249
Vanda Pharmaceuticals
- Recruiting
Vanda Investigational Site
Snellville, Georgia, 30078
Vanda Pharmaceuticals
- Recruiting
Vanda Investigational Site
Stockbridge, Georgia, 30281
Vanda Pharmaceuticals
- Recruiting
Vanda Investigational Site
Winter Park, Florida, 32789
Vanda Pharmaceuticals
- Recruiting
Vanda Investigational Site
Worcester, Massachusetts, 01608
Vanda Pharmaceuticals
United Kingdom7 sites, 7 recruiting
- Recruiting
Vanda Investigational Site
Great Yarmouth, NR31 6LA
Vanda Pharmaceuticals
- Recruiting
Vanda Investigational Site
Leicester, LE1 5WW
Vanda Pharmaceuticals
- Recruiting
Vanda Investigational Site
Liverpool, L12 2AP
Vanda Pharmaceuticals
- Recruiting
Vanda Investigational Site
London, E1 1FR
Vanda Pharmaceuticals
- Recruiting
Vanda Investigational Site
London, SE1 7EH
Vanda Pharmaceuticals
- Recruiting
Vanda Investigational Site
London, SE6 4LF
Vanda Pharmaceuticals
- Recruiting
Vanda Investigational Site
Sheffield, S10 2TH
Vanda Pharmaceuticals
Poland5 sites, 5 recruiting
- Recruiting
Vanda Investigational Site
Bydgoszcz, 85-092
Vanda Pharmaceuticals
- Recruiting
Vanda Investigational Site
Gdansk, 80-546
Vanda Pharmaceuticals
- Recruiting
Vanda Investigational Site
Krakow, 30-721
Vanda Pharmaceuticals
- Recruiting
Vanda Investigational Site
Poznan, 60-848
Vanda Pharmaceuticals
- Recruiting
Vanda Investigational Site
Wroclaw, 50-414
Vanda Pharmaceuticals
Germany2 sites, 2 recruiting
- Recruiting
Vanda Investigational Site
Berlin, 10117
Vanda Pharmaceuticals
- Recruiting
Vanda Investigational Site
Leipzig, 04177
Vanda Pharmaceuticals
About this study
Official title: 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.
- Conditions
- Insomnia Disorder
- Being tested
- Tasimelteon Oral Suspension, Placebo
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tasimelteon Oral SuspensionDrug
Single daily dose, weight-based liquid suspension formulation.
PlaceboDrug
Placebo comparator.
| Study group | Role | What they receive |
|---|---|---|
| Tasimelteon | Experimental | Not described Receives: Drug: Tasimelteon Oral Suspension |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep latency, as measured by daily sleep diary.
Measured: 12 Weeks
Secondary outcomes (6)
Change in nighttime subjective sleep parameters, such as sleep quality, as measured by sleep diary.
Measured: 12 Weeks
Change in nighttime subjective sleep parameters, such as sleep time, as measured by sleep diary.
Measured: 12 Weeks
Change in daytime functioning, as measured by questionnaire.
Measured: 12 Weeks
Change in behavior, as measured by questionnaire.
Measured: 12 Weeks
Change in nighttime objective sleep parameters such as sleep time, as measured by actigraphy.
Measured: 12 Weeks
Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs).
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start21 Apr 2025
- Primary completionNov 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia DisorderStudies of the same condition, open and under way.
- More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953869
- Sponsor's protocol ID
- VP-VEC-162-3108
- Status last verified
- Jun 2026
- First submitted
- 1 Apr 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
- ClinicalTrials.gov ID
- NCT06953869
- Acronym / sponsor ID
- VP-VEC-162-3108
- Conditions
- Insomnia Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tasimelteon | Experimental | Drug: Tasimelteon Oral Suspension |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tasimelteon Oral SuspensionSingle daily dose, weight-based liquid suspension formulation. | Drug | Tasimelteon |
| PlaceboPlacebo comparator. | Drug | Placebo |
Primary outcome
Change in sleep latency, as measured by daily sleep diary.
Time frame: 12 Weeks
6 secondary outcomes
Change in nighttime subjective sleep parameters, such as sleep quality, as measured by sleep diary.
Time frame: 12 Weeks
Change in nighttime subjective sleep parameters, such as sleep time, as measured by sleep diary.
Time frame: 12 Weeks
Change in daytime functioning, as measured by questionnaire.
Time frame: 12 Weeks
Change in behavior, as measured by questionnaire.
Time frame: 12 Weeks
Change in nighttime objective sleep parameters such as sleep time, as measured by actigraphy.
Time frame: 12 Weeks
Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs).
Time frame: 12 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
35 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tasimelteon Oral Suspension in people with Insomnia Disorder, run by Vanda Pharmaceuticals at 35 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, United Kingdom, Poland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanda Pharmaceuticals, Inc. (202-734-3400, VEC162@vandapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sleep latency, as measured by daily sleep diary. (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.