Tasimelteon for Delayed Sleep-Wake Phase Disorder

Recruiting at 34 trial locations

Overseen By Mallery Mayo

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Vanda Pharmaceuticals

Disqualifiers: Psychiatric condition, Major surgery, 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

70 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a pill called tasimelteon in people who have trouble falling asleep and waking up at normal times. The goal is to see if tasimelteon can help reset their sleep schedule. Both men and women with this sleep disorder are included in the study.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Tasimelteon for Delayed Sleep-Wake Phase Disorder?

Tasimelteon has been shown to help align sleep patterns with the 24-hour day in people with non-24-hour sleep-wake disorder, improving nighttime sleep and reducing daytime sleepiness. It also increased sleep time and alertness in a study simulating jet lag, suggesting it may help with sleep timing issues like those in Delayed Sleep-Wake Phase Disorder. ^{1 2 3 4 5}

Is tasimelteon safe for humans?

Tasimelteon is generally well tolerated in humans, with common side effects including headache, unusual dreams, and mild infections. Long-term use is considered safe, and it has been approved by the FDA for treating certain sleep disorders. ^{2 3 6 7 8}

How does the drug tasimelteon differ from other treatments for Delayed Sleep-Wake Phase Disorder?

Tasimelteon is unique because it is a melatonin receptor agonist specifically designed to help regulate the body's internal clock, making it particularly effective for circadian rhythm disorders like Delayed Sleep-Wake Phase Disorder. It is the first and only drug approved by the FDA for a similar condition, non-24-hour sleep-wake disorder, and works by helping to synchronize the sleep-wake cycle with the 24-hour day. ^{2 3 6 7 9}

Eligibility Criteria

This trial is for men and women aged 18-75 with a confirmed diagnosis of Delayed Sleep-Wake Phase Disorder (DSWPD). Participants must have a BMI between 18 and 35, be able to consent, and not have had psychiatric disorders in the past year. Pregnant or breastfeeding women, recent surgery patients, or those who've been immobile for extended periods cannot join.

Inclusion Criteria

Ability and acceptance to provide written informed consent.

Your body mass index (BMI) is between 18 and 35.

You have been diagnosed with Delayed Sleep-Wake Phase Disorder (DSWPD).

Exclusion Criteria

History of psychiatric disorders within 12 months.

Major surgery, trauma, illness, general anesthesia, or immobility for 3 or more days within the last 30 days.

Pregnancy, recent pregnancy (within 6 weeks), or women who are breastfeeding.

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

• Placebo
• Tasimelteon

Trial Overview The study compares the effects of Tasimelteon—a medication—against a placebo in treating DSWPD. It's conducted across multiple centers where participants are randomly assigned to receive either Tasimelteon or an inactive pill without knowing which one they're getting.

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

In a study involving 48 healthy adults, tasimelteon, a melatonin receptor agonist, did not significantly impair next-day driving performance compared to a placebo, indicating it may be a safer option for improving sleep without affecting motor skills.

In contrast, the active control zopiclone significantly impaired driving performance, highlighting tasimelteon's unique profile as a sleep aid that does not compromise safety in operating vehicles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simulated driving performance in healthy adults after night-time administration of 20 mg tasimelteon. Torres, R., Fisher, M., Birznieks, G., et al.[2022]

Tasimelteon has been shown to significantly improve sleep initiation and maintenance in patients with Non-24-hour sleep-wake disorder, based on results from multiple clinical trials involving up to 412 participants.

The drug effectively shifts circadian rhythms, with significant improvements in sleep efficiency and entrainment observed, particularly at a dosage of 20 mg, although its high cost may limit accessibility for some patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tasimelteon: a melatonin receptor agonist for non-24-hour sleep-wake disorder. Johnsa, JD., Neville, MW.[2018]

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]

In a study involving 320 healthy adults, tasimelteon significantly improved sleep duration by increasing total sleep time during the first two-thirds of the night by 60.3 minutes and overall sleep time by 85.5 minutes, demonstrating its efficacy in treating Jet Lag Disorder (JLD).

Tasimelteon also enhanced next-day alertness and reduced sleepiness, indicating that it not only helps with nighttime sleep but also improves daytime functioning after experiencing circadian misalignment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Tasimelteon (HETLIOZ®) in the Treatment of Jet Lag Disorder Evaluated in an 8-h Phase Advance Model; a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Polymeropoulos, CM., Mohrman, MA., Keefe, MS., et al.[2020]

In a randomized, double-blind trial with 8 subjects suffering from delayed sleep phase syndrome, melatonin (5 mg) significantly advanced sleep onset by an average of 82 minutes and wake time by 117 minutes compared to placebo, indicating its efficacy in regulating sleep-wake cycles.

While melatonin treatment resulted in slightly less total sleep time (8 hours 12 minutes) compared to placebo (8 hours 46 minutes), it did not affect overall alertness, suggesting that melatonin primarily functions as a phase-setter rather than increasing total sleep duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delayed sleep phase syndrome response to melatonin. Dahlitz, M., Alvarez, B., Vignau, J., et al.[2019]

Tasimelteon is an effective treatment for non-24 sleep-wake rhythm disorder, helping to resynchronize the circadian rhythms of individuals who are totally blind, with significant improvements in sleep-wake functions.

Long-term use of tasimelteon is safe and well tolerated, and it is the only FDA and EMA approved medication specifically for non-24, with studies showing that 90% of patients who continued treatment maintained circadian entrainment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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 (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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Simulated driving performance in healthy adults after night-time administration of 20 mg tasimelteon. [2022]

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

Tasimelteon: a melatonin receptor agonist for non-24-hour sleep-wake disorder. [2018]

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

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of Tasimelteon (HETLIOZ®) in the Treatment of Jet Lag Disorder Evaluated in an 8-h Phase Advance Model; a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. [2020]

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

Delayed sleep phase syndrome response to melatonin. [2019]

6. England pubmed.ncbi.nlm.nih.gov

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

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

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

8. 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]

9. 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]