Tasimelteon for REM Sleep Behavior Disorder

(RBD Trial)

Overseen By Milena Pavlova, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Brigham and Women's Hospital

Disqualifiers: Contraindication to tasimelteon, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

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 helps people with REM Sleep Behavior Disorder (RBD). RBD can cause individuals to act out their dreams, leading to disruptions. The study aims to discover if taking 20 mg of tasimelteon nightly reduces these dream enactments and improves sleep quality. Individuals diagnosed with RBD may be suitable candidates for participation. The trial also evaluates the safety and tolerability of the medication. As an Early Phase 1 trial, this study focuses on understanding how tasimelteon works in people, offering participants a chance to contribute to groundbreaking research.

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 safe and generally well-tolerated. Earlier studies found it did not disrupt sleep patterns or cause unusual sleep behaviors, indicating a low risk of sleep-related side effects. Tasimelteon is already approved for treating certain sleep issues, further supporting its safety for most people. Although this trial is in its early stages, the existing safety data encourages potential participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Tasimelteon is unique because it specifically targets the circadian rhythm, which is a different approach compared to most current treatments for REM Sleep Behavior Disorder, like clonazepam or melatonin supplements. While typical treatments often focus on managing symptoms, tasimelteon, a melatonin receptor agonist, works by aligning the sleep-wake cycle, potentially addressing one of the underlying causes of the disorder. Researchers are excited about this because it could offer a more targeted and effective solution, improving sleep quality and safety for those affected by this condition.

What evidence suggests that tasimelteon might be an effective treatment for REM Sleep Behavior Disorder?

Research has shown that tasimelteon, a drug similar to melatonin, can help regulate sleep patterns. In studies, participants experienced better sleep from the first night of using tasimelteon, with benefits continuing over time. This trial will administer tasimelteon to participants with REM Sleep Behavior Disorder. The drug has generally been well tolerated and has improved sleep and daily functioning. By syncing the body's internal clock, the treatment may reduce acting out dreams. Tasimelteon is already used to treat sleep problems in conditions like Smith-Magenis syndrome, demonstrating its effectiveness in managing sleep issues. ^{1 3 5 6 7}

Who Is on the Research Team?

Milena Pavlova, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for individuals who have been diagnosed with REM Sleep Behavior Disorder, confirmed by a sleep study. Participants must be able to engage in the trial activities and not have any medical or psychiatric conditions that could limit their participation or increase their risk.

Inclusion Criteria

I am able to take part in the clinical trial.

I have been diagnosed with REM sleep behavior disorder through a sleep study.

Exclusion Criteria

I cannot take tasimelteon due to health reasons.

I do not have any health or mental conditions that would make it unsafe for me to join.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants maintain a daily sleep diary to establish baseline sleep patterns and dream enactment events

4 weeks

Daily self-reporting

Treatment

Participants receive a nightly dose of 20 mg tasimelteon and continue daily sleep diary entries

4 weeks

Daily self-reporting

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 trial is testing the effects of a daily dose of tasimelteon (20 mg) on dream enactment behaviors in RBD patients. It also examines its impact on insomnia symptoms using questionnaires and activity patterns via actigraphy, as well as how melatonin secretion levels and genetics might influence treatment response.

How Is the Trial Designed?

Group I: Treatment Phase Experimental Treatment 1 Intervention

Tasimelteon will be administered in 20 mg capsules on a nightly basis for 4 weeks during the treatment phase.

Tasimelteon is already approved in United States, European Union for the following indications:

Approved in United States as Hetlioz for:

• Non-24-Hour Sleep-Wake Disorder
• Nighttime sleep disturbances in Smith-Magenis Syndrome

Approved in European Union as Hetlioz for:

• Non-24-hour sleep-wake rhythm disorder in totally blind adults

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Vanda Pharmaceuticals

Industry Sponsor

Trials

68

Recruited

19,900+

Published Research Related to This Trial

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 (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 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, 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, the first approved treatment for Non-24-Hour Sleep-Wake Disorder, is a potent Dual Melatonin Receptor Agonist with significantly higher affinity for the MT2 receptor, which is important for regulating circadian rhythms.

In extensive testing, tasimelteon showed minimal interaction with over 160 other receptors and enzymes, suggesting a favorable safety profile and specificity for its intended action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05922995

The Effects of Tasimelteon in Participants With REM ... To assess the effects of a daily single oral dose of 20 mg tasimelteon compared to baseline on events of dream enactment on patients with REM Behavior ...

2. 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 ...

3. withpower.com withpower.com/trial/early-phase-1-rem-sleep-behavior-disorder-8-2023-5ddbd

Tasimelteon for REM Sleep Behavior Disorder (RBD Trial) Tasimelteon was generally well tolerated and also led to improvements in sleep/wake parameters and overall functioning, making it a valuable treatment option ...

4. trial.medpath.com trial.medpath.com/drug/e6cd1999923d084d/tasimelteon

Tasimelteon | MedPath Tasimelteon oral suspension is indicated for the treatment of nighttime sleep disturbances in Smith-Magenis syndrome in patients 3 to 15 years of age.

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

Hetlioz | EMA ... tasimelteon results in disturbance of the sleep architecture, disruptive sleep behaviours nor parasomnias. The CHMP was of the opinion, that ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7381312/

Efficacy of Tasimelteon (HETLIOZ®) in the Treatment of Jet ... Tasimelteon treatment increased TST2/3 (primary endpoint) by 60.3 min (95%CI 44.0 to 76.7, P < 0.0001) and whole night TST by 85.5 min (95% CI 64.3 to 106.6, P ...