Autism Spectrum DisorderPhase 3NCT05361707
Evaluating the Effects of Tasimelteon in Individuals With Autism Spectrum Disorder (ASD) and Sleep Disturbances
A Phase 3 study testing Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension in people with Autism Spectrum Disorder and Sleep Disorder, run by Vanda Pharmaceuticals at 5 sites in United States.
Trial summary
This is a multicenter, open-label study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon in treating sleep disturbances in pediatric and adult participants with ASD. Read more about this study
- Who is it for?
- Ages 2 to 65 years
- Conditions the study is for
- Autism Spectrum Disorder, Sleep Disorder, Neurological Disorder
- What is being tested?
- Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesUnited States
- Study dates
- 28 Jul 2021to Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ability and acceptance to provide written informed consent of the participant or legal guardian (and assent as required).
- A confirmed clinical diagnosis of Autism Spectrum Disorder (ASD) and a recent history of sleep disturbances.
- The sleep disturbance must not be a result of another diagnosable disorder or medication.
- Male or female between 2 and 65 years of age, inclusive.
- Willing and able to comply with study requirements and restrictions.
Who cannot join
- Inability to dose daily with tasimelteon or previous intolerance to tasimelteon.
- Indication of impaired liver function.
- Evidence of increased risk of self-harm.
- Pregnant or lactating females.
- A positive test for drugs of abuse.
- Other diagnosable causes of sleep disorders or use of medications that may cause sedation or stimulation.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Vanda Investigational Site
Boulder, Colorado, 80301
Vanda Pharmaceuticals, 202-734-3400
- Recruiting
Vanda Investigational Site
San Jose, California, 95124
Vanda Pharmaceuticals, 202-734-3400
- Recruiting
Vanda Investigational Site
San Leandro, California, 94578
Vanda Pharmaceuticals, 202-734-3400
- Recruiting
Vanda Investigational Site
Santa Monica, California, 90404
Vanda Pharmaceuticals, 202-734-3400
- Recruiting
Vanda Investigational Site
Staten Island, New York, 10312
Vanda Pharmaceuticals, 202-734-3400
About this study
Official title: A Study to Evaluate the Efficacy and Safety of Tasimelteon in Treating Sleep Disturbances in Individuals With Autism Spectrum Disorder
This is a multicenter, open-label study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon in treating sleep disturbances in pediatric and adult participants with ASD.
- Being tested
- Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension
- Medical subject headings
- Autism Spectrum Disorder, Sleep Wake Disorders, Nervous System Diseases, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tasimelteon Oral Capsule, Tasimelteon Liquid SuspensionDrug
Once Daily
| Study group | Role | What they receive |
|---|---|---|
| Tasimelteon | Experimental | Drug: Tasimelteon Receives: Drug: Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep time over the treatment period, as measured by sleep diary.
Measured: 12 weeks
Secondary outcomes (3)
Improvement in objective sleep-wake parameters such as severity of condition, as measured by administered questionnaires.
Measured: 12 weeks
Improvement in objective behavioral parameters such as the participant's overall behavior, as measured by sleep diary in the Patient Global Impression of Severity Behavior Questionnaire (PGI-S Behavior).
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 posted5 May 2022
- Study start28 Jul 2021
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT05361707
- Sponsor's protocol ID
- VP-VEC-162-3601
- Status last verified
- Mar 2024
- First submitted
- 5 Oct 2021
- Last updated
- 21 Mar 2024
- Results posted
- 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 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy and Safety of Tasimelteon in Treating Sleep Disturbances in Individuals With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05361707
- Acronym / sponsor ID
- VP-VEC-162-3601
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 5 May 2022 (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, open-label study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon in treating sleep disturbances in pediatric and adult participants with ASD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tasimelteon | Experimental | Drug: Tasimelteon Oral Capsule, Tasimelteon Liquid SuspensionDrug: Tasimelteon |
Who may qualify
- Ages
- 2 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Ability and acceptance to provide written informed consent of the participant or legal guardian (and assent as required).
- A confirmed clinical diagnosis of Autism Spectrum Disorder (ASD) and a recent history of sleep disturbances.
- The sleep disturbance must not be a result of another diagnosable disorder or medication.
- Male or female between 2 and 65 years of age, inclusive.
- Willing and able to comply with study requirements and restrictions.
Key exclusion criteria (6 listed)
- Inability to dose daily with tasimelteon or previous intolerance to tasimelteon.
- Indication of impaired liver function.
- Evidence of increased risk of self-harm.
- 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 Capsule, Tasimelteon Liquid SuspensionOnce Daily | Drug | Tasimelteon |
Primary outcome
Change in sleep time over the treatment period, as measured by sleep diary.
Time frame: 12 weeks
3 secondary outcomes
Improvement in objective sleep-wake parameters such as severity of condition, as measured by administered questionnaires.
Time frame: 12 weeks
Improvement in objective behavioral parameters such as the participant's overall behavior, as measured by sleep diary in the Patient Global Impression of Severity Behavior Questionnaire (PGI-S Behavior).
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- 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. This study is not recruiting at the moment.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension in people with Autism Spectrum Disorder and Sleep Disorder, run by Vanda Pharmaceuticals at 5 sites in United States.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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. 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?
Results are not available in the source record.
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 time over the treatment period, as measured by 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 21 Mar 2024.