Tasimelteon for Autism and Sleep Disorders

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Vanda Pharmaceuticals

Must not be taking: Sedatives, Stimulants

Disqualifiers: Impaired liver function, Pregnancy, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a daily pill called tasimelteon to help children and adults with Autism Spectrum Disorder (ASD) who have trouble sleeping. The medication aims to improve sleep by helping to regulate the body's internal clock.

Will I have to stop taking my current medications?

The trial requires that participants do not use medications that may cause sedation or stimulation, so you might need to stop taking such medications.

What data supports the effectiveness of the drug Tasimelteon for treating sleep disorders in autism?

Tasimelteon has been shown to help regulate sleep patterns in people with Non-24-Hour Sleep-Wake Disorder, especially in totally blind individuals, by aligning their sleep-wake cycles with the 24-hour day. This suggests it might also help with sleep issues in autism, as it works by targeting melatonin receptors to improve sleep-wake functions. ^{1 2 3 4 5}

Is Tasimelteon safe for humans?

Tasimelteon has been generally well tolerated in studies, with common mild side effects like headache, unusual dreams, and minor infections. No serious adverse events or deaths were reported, and it is considered safe for long-term use in treating sleep disorders. ^{1 2 3 4 6}

How is the drug Tasimelteon unique for treating autism and sleep disorders?

Tasimelteon is unique because it is a dual melatonin receptor agonist, specifically targeting the MT2 receptor to help regulate the body's internal clock, which is different from other treatments that may not focus on circadian rhythm adjustment. It is also the first drug approved for Non-24-Hour Sleep-Wake Disorder, highlighting its novel approach to sleep regulation. ^{1 2 3 6 7}

Research Team

Eligibility Criteria

This trial is for children and adults aged 2 to 65 with Autism Spectrum Disorder (ASD) who have trouble sleeping. Participants must be able to follow the study's rules and give consent, or have a guardian who can consent for them. They shouldn't have liver problems, drug abuse issues, or other sleep disorders caused by different conditions.

Inclusion Criteria

Ability and acceptance to provide written informed consent of the participant or legal guardian (and assent as required)

Willing and able to comply with study requirements and restrictions

I have been diagnosed with ASD and have recent trouble sleeping.

Exclusion Criteria

My liver isn't working properly.

Pregnant or lactating females

Evidence of increased risk of self-harm

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a daily single oral dose of tasimelteon to treat sleep disturbances

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Tasimelteon (Melatonin Receptor Agonist)

Trial Overview The trial is testing how safe and effective tasimelteon, taken as an oral capsule or liquid suspension once daily, is at improving sleep in people with ASD. It's an open-label study which means everyone knows they're getting the actual medication.

Participant Groups

Group I: Tasimelteon Experimental Treatment 1 Intervention

Drug: Tasimelteon

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Vanda Investigational Site Staten Island, NY

Vanda Investigational Site Boulder, CO

Vanda Investigational Site Santa Monica, CA

Vanda Investigational Site San Jose, CA

More Trial Locations

Who Is Running the Clinical Trial?

Vanda Pharmaceuticals

Lead Sponsor

Trials

68

Patients Recruited

19,900+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tasimelteon: A Review in Non-24-Hour Sleep-Wake Disorder in Totally Blind Individuals. Keating, GM.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tasimelteon (Hetlioz™): A New Melatonin Receptor Agonist for the Treatment of Non-24-Hour Sleep-Wake Disorder. Bonacci, JM., Venci, JV., Gandhi, MA.[2015]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tasimelteon for the treatment of non-24-hour sleep-wake disorder. Neubauer, DN.[2017]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tasimelteon for treating non-24-h sleep-wake rhythm disorder. Nishimon, S., Nishimon, M., Nishino, S.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of tasimelteon, a melatonin MT1 and MT2 receptor agonist: pooled safety analyses from six clinical studies. Leger, D., Quera-Salva, MA., Vecchierini, MF., et al.[2015]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Absolute Bioavailability of Tasimelteon. Torres, R., Dressman, MA., Kramer, WG., et al.[2015]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tasimelteon: a selective and unique receptor binding profile. Lavedan, C., Forsberg, M., Gentile, AJ.[2015]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Tasimelteon: A Review in Non-24-Hour Sleep-Wake Disorder in Totally Blind Individuals. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Tasimelteon (Hetlioz™): A New Melatonin Receptor Agonist for the Treatment of Non-24-Hour Sleep-Wake Disorder. [2015]

3. Spain pubmed.ncbi.nlm.nih.gov

Tasimelteon for the treatment of non-24-hour sleep-wake disorder. [2017]

4. England pubmed.ncbi.nlm.nih.gov

Tasimelteon for treating non-24-h sleep-wake rhythm disorder. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Safety profile of tasimelteon, a melatonin MT1 and MT2 receptor agonist: pooled safety analyses from six clinical studies. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Absolute Bioavailability of Tasimelteon. [2015]

7. England pubmed.ncbi.nlm.nih.gov

Tasimelteon: a selective and unique receptor binding profile. [2015]