Tasimelteon for Delayed Sleep-Wake Phase Disorder

Recruiting at 35 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of tasimelteon in treating Delayed Sleep-Wake Phase Disorder (DSWPD), a condition where individuals struggle to fall asleep and wake up at typical times. Participants will receive either tasimelteon or a placebo (a substance with no active medicine) to determine if the drug can improve sleep patterns. Individuals diagnosed with DSWPD who find it affects their daily life might be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment.

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.

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

Research has shown that tasimelteon is generally safe for people. One study found that tasimelteon, used to treat Non-24 sleep-wake disorder, offers more benefits than risks for most individuals. The FDA has approved tasimelteon for those with Smith-Magenis Syndrome to help with nighttime sleep problems, indicating its safety.

Reports of side effects exist, but they are usually mild. Common side effects include headaches, bad dreams, and mild colds, which are not serious for most people. Prospective trial participants might find this information reassuring regarding the treatment's safety. ^{1 2 3 4 5}

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

Tasimelteon is unique because it specifically targets the body's internal clock, or circadian rhythm, which is often out of sync in people with Delayed Sleep-Wake Phase Disorder (DSWPD). Unlike the standard treatments, such as melatonin supplements and light therapy, which indirectly influence sleep patterns, Tasimelteon works as a melatonin receptor agonist, directly engaging with melatonin receptors to adjust the timing of sleep. Researchers are excited about Tasimelteon because it offers a more targeted approach, potentially leading to more consistent and reliable improvements in sleep timing for those struggling with DSWPD.

What evidence suggests that tasimelteon might be an effective treatment for delayed sleep-wake phase disorder?

In this trial, participants will receive either tasimelteon or a placebo. Studies have shown that tasimelteon can improve sleep patterns by mimicking melatonin, a natural hormone that regulates sleep. Tasimelteon has proven effective from the first night of use, with benefits continuing throughout treatment. It is already approved for treating sleep problems in some conditions, suggesting it could help with Delayed Sleep-Wake Phase Disorder (DSWPD). Research indicates that tasimelteon is well-tolerated, making it a promising option for those struggling with sleep issues. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

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 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

• 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.

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

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]

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 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]

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

Melatonin agonist tasimelteon (HETLIOZ®) improves sleep in ... HETLIOZ LQ® (tasimelteon oral suspension) is approved for the treatment of the nighttime sleep disturbances in SMS in pediatric patients 3 years ...

2. 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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40971945/

Melatonin agonist tasimelteon (HETLIOZ®) improves sleep ... Conclusion: Tasimelteon improved sleep from the first night of treatment, and the effect continued for the duration of the study. Tasimelteon ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04652882

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.

5. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2014/205677orig1s000medr.pdf

205677Orig1s000 - accessdata.fda.gov Efficacy: Applicant's Efficacy Conclusions: Tasimelteon is a circadian regulator that entrains the master body clock in totally blind ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2020/214517s000lbl.pdf

Hetlioz (tasimelteon) - accessdata.fda.gov Safety and effectiveness of HETLIOZ LQ oral suspension for the treatment of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) have been ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01163032

NCT01163032 | Efficacy and Safety of Tasimelteon ... LQ-nTST measures the difference in average nighttime sleep during the patient's worst 25% of nights (shortest total nighttime sleep) between the randomized ...

8. hca.wa.gov hca.wa.gov/assets/billers-and-providers/sleep-disorder-tasimelteon.pdf

Sleep Disorder Agents – Hetlioz (tasimelteon) History of insomnia or excessive daytime sleepiness alternating with asymptomatic episodes; AND b. Symptoms have persisted for at least 3 months ...

9. ema.europa.eu ema.europa.eu/en/documents/assessment-report/hetlioz-epar-public-assessment-report_en.pdf

Hetlioz | EMA The CHMP considers benefit-risk balance of tasimelteon in the treatment of Non-24 sleep-wake disorder to be positive. Discussion on the ...