Tasimelteon for Pediatric Insomnia

Recruiting at 2 trial locations

Overseen By Vanda Pharmaceuticals, Inc.

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Vanda Pharmaceuticals

Disqualifiers: Impaired liver function, Pregnancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

420 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called tasimelteon to determine if it can help children and teens with insomnia, a condition that makes falling or staying asleep difficult. The study compares tasimelteon to a placebo (an inactive pill) to assess its effectiveness and safety. Ideal candidates are children and teens aged 2 to 17 diagnosed with insomnia, where sleep issues aren't caused by other medications. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for insomnia.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, your sleep issues must not be caused by another medication.

Is there any evidence suggesting that tasimelteon is likely to be safe for humans?

Research has shown that tasimelteon is generally safe for use. Previous studies found that most people tolerated it well, experiencing few effects the next day. In one study, only 21.4% of participants reported mild side effects, and no serious side effects occurred. This indicates that most people did not encounter major problems while taking it. Tasimelteon is also approved for other conditions, suggesting its safety. Overall, the treatment appears safe based on the available data. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for insomnia?

Unlike other treatments for pediatric insomnia, which often rely on behavioral therapies or medications like melatonin supplements, Tasimelteon offers a novel approach. Tasimelteon is unique because it targets the body's internal clock, or circadian rhythm, by acting as a melatonin receptor agonist. This mechanism helps regulate sleep-wake cycles more naturally compared to traditional options. Researchers are excited about this treatment's potential to provide a more precise and effective way to help children with insomnia get a good night's sleep.

What evidence suggests that tasimelteon might be an effective treatment for pediatric insomnia?

Research has shown that tasimelteon, a drug similar to melatonin, can improve sleep. Studies have found that it helps people with insomnia fall asleep faster, starting from the first night and continuing throughout the treatment period. Tasimelteon is generally well-tolerated, causing no next-day problems. Although primarily approved for Non-24-Hour Sleep-Wake Disorder, these findings suggest it might also benefit children with insomnia. Participants in this trial will receive either tasimelteon or a placebo to evaluate its effectiveness for pediatric insomnia. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for boys and girls with trouble sleeping, known as insomnia. Participants must meet certain health requirements to join, but specific inclusion criteria are not listed here. People who have conditions or circumstances that could interfere with the study or pose a risk may be excluded.

Inclusion Criteria

I have been diagnosed with insomnia.

I am between 2 and 17 years old.

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

Exclusion Criteria

A positive test for drugs of abuse

I cannot take tasimelteon daily or have had a bad reaction to it before.

My liver isn't working properly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a daily single oral dose of tasimelteon or placebo

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tasimelteon

Trial Overview

The study is testing tasimelteon, a medication given as an oral suspension, against a placebo (a substance with no active drug). It's designed so neither the researchers nor participants know who gets the real medicine versus the placebo to fairly measure its effects on pediatric insomnia.

How Is the Trial Designed?

Group I: Tasimelteon Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Vanda Pharmaceuticals

Lead Sponsor

Trials

68

Recruited

19,900+

Published Research Related to This Trial

In two phase III trials involving totally blind individuals with Non-24-Hour Sleep-Wake Disorder, tasimelteon (20 mg once nightly) significantly improved the ability to entrain the circadian pacemaker compared to placebo.

Tasimelteon was generally well tolerated and also led to improvements in sleep/wake parameters and overall functioning, making it a valuable treatment option for Non-24 in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Tasimelteon, a dual melatonin receptor agonist approved for Non-24-Hour Sleep-Wake Disorder, showed an absolute bioavailability of 38% in a study involving 14 healthy volunteers, indicating effective absorption when taken orally.

The study found that tasimelteon was well tolerated, with only mild treatment-emergent adverse events reported in 21.4% of participants, and no serious adverse events or discontinuations, highlighting its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Tasimelteon (Hetlioz®) is the first FDA-approved treatment for non-24-hour sleep-wake disorder, particularly effective in blind individuals, as it helps reduce nighttime wakefulness and daytime sleepiness by promoting synchronization to the 24-hour cycle.

The drug is well tolerated with common side effects including headaches and unusual dreams, and ongoing safety studies are being conducted to further assess its effects in blind patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Melatonin significantly reduced sleep onset time (SOT) by an average of 0.62 hours and improved dim light melatonin onset (DLMO) by 0.82 hours in children and adolescents with sleep onset insomnia, based on a review of seven trials involving 387 participants.

The treatment was found to be effective and generally well-tolerated, with no significant differences in dropout rates due to adverse events, although some mild adverse effects were reported, indicating a need for further research, especially in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of melatonin for sleep onset insomnia in children and adolescents: a meta-analysis of randomized controlled trials. Wei, S., Smits, MG., Tang, X., et al.[2022]

Tasimelteon, a melatonin receptor agonist, is the first approved treatment for Non-24-hour Sleep-Wake Disorder, showing a strong affinity for the MT2 receptor, which helps regulate sleep cycles.

In a study involving 184 blind individuals over more than a year, tasimelteon was found to be safe and well-tolerated, with adverse effects similar to those seen in placebo groups, indicating its potential for long-term use.

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]

Tasimelteon (Hetlioz™) is a melatonin-receptor agonist approved by the FDA in January 2014 specifically for treating non-24-hour sleep-wake disorder, indicating its targeted therapeutic use.

The article reviews tasimelteon's mechanism of action, pharmacokinetics, and its clinical efficacy, safety, and tolerability, highlighting its potential benefits for individuals with this specific sleep disorder.

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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06953869

Evaluating the Effects of Tasimelteon vs. Placebo in ...

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 ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12449008/

Melatonin agonist tasimelteon (HETLIOZ®) improves sleep in ...

Tasimelteon was well-tolerated with no adverse next-day residual effects observed. The results of the study strongly suggest that tasimelteon ...

3.

psychiatrictimes.com

psychiatrictimes.com/view/phase-3-results-hetlioz-improves-sleep-in-patients-with-primary-insomnia

Phase 3 Results: Hetlioz Improves Sleep in Patients With ...

Tasimelteon (Hetlioz) showed significant improvement in sleep latency in a phase 3 study for insomnia, with effects persisting throughout the ...

4.

journals.plos.org

journals.plos.org/plosone/article?id=10.1371/journal.pone.0332366

Melatonin agonist tasimelteon (HETLIOZ®) improves sleep in ...

Tasimelteon improved sleep from the first night of treatment, and the effect continued for the duration of the study. Tasimelteon was well-tolerated with no ...

5.

withpower.com

withpower.com/trial/tasimelteon-for-pediatric-insomnia-95d15

Tasimelteon for Pediatric Insomnia

Tasimelteon, a dual melatonin receptor agonist approved for Non-24-Hour Sleep-Wake Disorder, showed an absolute bioavailability of 38% in a study involving 14 ...