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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug Tasimelteon for pediatric insomnia?

Tasimelteon is a drug that helps regulate sleep patterns by acting on melatonin receptors, and it has been shown to be effective in treating sleep disorders like non-24-hour sleep-wake disorder and transient insomnia in adults. While specific data for pediatric insomnia is not available, its success in managing similar sleep issues in adults suggests it may be beneficial for children as well. ^{1 2 3 4 5}

Is Tasimelteon safe for use in humans?

In a study with 14 healthy volunteers, Tasimelteon was well tolerated, with only mild side effects reported, and no serious adverse events or discontinuations occurred. ^{1 2 6 7 8}

How is the drug Tasimelteon unique for treating pediatric insomnia?

Tasimelteon is unique because it is a melatonin receptor agonist, specifically targeting the MT1 and MT2 receptors, which helps regulate the sleep-wake cycle. It is the first drug approved for Non-24-Hour Sleep-Wake Disorder, showing its potential in managing circadian rhythm-related sleep issues, which may offer a novel approach for pediatric insomnia. ^{1 2 3 4 9}

Eligibility Criteria

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.

My sleep problems are not caused by another medication.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 (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]

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]

References

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

Absolute Bioavailability of Tasimelteon. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Tasimelteon for insomnia. [2013]

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

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

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

Melatonin agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomised controlled multicentre trials. [2015]

6. Netherlands 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. [2022]

7. 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]

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

Pharmacological treatment of sleep disturbance in developmental disabilities: a review of the literature. [2015]

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

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