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Tasimelteon for Delayed Sleep-Wake Phase Disorder

Phase 3
Recruiting
Research Sponsored by Vanda Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Study Summary

This trial is testing a new sleep medication for people with Delayed Sleep Wake Phase Disorder. The trial is double-blind, meaning that neither the participants nor the researchers will know who is taking the medication and who is taking the placebo.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed here, clinical trials like this often monitor for any adverse reactions ranging from mild discomforts such as headaches or nausea to more serious conditions that could affect sleep patterns, mood, or physical health.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Sleep Onset over the treatment period, as measured by sleep diary.
Secondary outcome measures
Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs).
Change in nighttime objective sleep-wake parameters such as sleep time, as measured by actigraphy.
Change in nighttime subjective sleep-wake parameters such as sleep time, as measured by sleep diary.

Side effects data

From 2018 Phase 3 trial • 320 Patients • NCT03373201
5%
Headache
1%
Atrial Fibrillation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Tasimelteon

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TasimelteonExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tasimelteon
2016
Completed Phase 3
~540

Find a Location

Who is running the clinical trial?

Vanda PharmaceuticalsLead Sponsor
61 Previous Clinical Trials
19,104 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04652882 — Phase 3
Chronobiology Disorders Research Study Groups: Tasimelteon, Placebo
Chronobiology Disorders Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04652882 — Phase 3
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04652882 — Phase 3
Chronobiology Disorders Patient Testimony for trial: Trial Name: NCT04652882 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you give me a ballpark number of individuals taking part in this research?

"According to the latest information available on clinicaltrials.gov, this particular trial is still looking for volunteers. The first posting was on December 9th 2020 and the most recent update was January 12th 2022. They are aiming to recruit 300 patients from 19 different locations."

Answered by AI

Does this clinical trial represent a new development in medical research?

"Tasimelteon is being studied in 2 active clinical trials that are spread out over 20 cities and 1 nation. The first trial for Tasimelteon was completed in 2016 by Vanda Pharmaceuticals. That initial study only had 24 participants and finished Phase 1 drug approval. Since then, 18300 more trials have been carried out."

Answered by AI

Has Tasimelteon been cleared by the FDA?

"Tasimelteon is considered safe (scoring a 3 on our 1-3 scale) as it has progressed to Phase 3 clinical trials. At this stage in testing, there is some data supporting efficacy and multiple rounds of data supporting safety."

Answered by AI

Who meets the eligibility requirements for this trial?

"This sleep study is currently recruiting 300 individuals that suffer from some form of insomnia. The participants must be 18-75 years old, have a BMI between 18 and 35 kg/m^2, and can be male or female."

Answered by AI

How does Tasimelteon compare to other drugs in its class?

"Tasimelteon is being studied in 2 active clinical trials, 1 of which is a Phase 3 study. Although the majority of research regarding Tasimelteon takes place in Baltimore, Maryland, there are 20 different locations conducting these medical investigations."

Answered by AI

Could you please provide a number of the hospitals currently testing this treatment?

"Currently, there are a total of 19 sites running this trial; Portland, Phoenix and Malvern being three of them. To decrease the logistical difficulties for patients, it is best to select a clinic that is close to your location."

Answered by AI

Does this research project restrict volunteers to people who are 25 years of age or younger?

"As per the requirements for this study, participants must be between 18-75 years old."

Answered by AI

Are we still enrolling new participants for this research?

"Yes, according to the information on clinicaltrials.gov, this clinical trial is currently recruiting participants. The trial was first posted on December 9th 2020 and was most recently updated on January 12th 2022. The clinical trial is looking for 300 participants across 19 sites."

Answered by AI

Who else is applying?

What state do they live in?
California
Other
Texas
Florida
How old are they?
18 - 65
What site did they apply to?
Other
Vanda Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I need to sleep! Nothing works! I have terrible insomnia and circadian rhythm issues.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)
2020. "Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04652882.
All > Sleep Disorder
~45 spots leftby Dec 2024
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