Evaluating Tasimelteon for Sleep Issues in Autism Spectrum Disorder
A Study to Evaluate the Efficacy and Safety of Tasimelteon in Treating Sleep Disturbances in Individuals With Autism Spectrum Disorder
This study is testing if a daily dose of tasimelteon can help people with Autism Spectrum Disorder, aged 2 to 65, who have trouble sleeping.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 2 Years to 65 Years |
| Sex | All |
| Sponsor | Vanda Pharmaceuticals Industry-sponsored |
| Locations | 5 sites (San Jose, California and 4 other locations) |
| Trial ID | NCT05361707 on ClinicalTrials.gov |
What this trial studies
This multicenter, open-label study aims to assess the efficacy and safety of a daily oral dose of tasimelteon in individuals diagnosed with Autism Spectrum Disorder (ASD) who experience sleep disturbances. Participants, ranging from ages 2 to 65, will receive either tasimelteon in capsule or liquid form. The study will focus on those whose sleep issues are not attributed to other medical conditions or medications. The primary goal is to determine if tasimelteon can effectively improve sleep quality in this population.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 2 to 65 with a confirmed diagnosis of Autism Spectrum Disorder and a recent history of sleep disturbances.
Not a fit: Patients with sleep disturbances caused by other diagnosable disorders or those who cannot tolerate tasimelteon may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve sleep quality and overall well-being for individuals with ASD experiencing sleep disturbances.
How similar studies have performed: While this approach is focused on a specific population, similar studies evaluating sleep interventions in ASD have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
San Jose, California and 4 other locations
- Vanda Investigational Site — San Jose, California, United States (Recruiting)
- Vanda Investigational Site — San Leandro, California, United States (Recruiting)
- Vanda Investigational Site — Santa Monica, California, United States (Recruiting)
- Vanda Investigational Site — Boulder, Colorado, United States (Recruiting)
- Vanda Investigational Site — Staten Island, New York, United States (Recruiting)
Study contacts
- Study coordinator: Vanda Pharmaceuticals Inc.
- Email: VEC162@vandapharma.com
- Phone: 202-734-3400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.