NCT04652882 Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)
| NCT ID | NCT04652882 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Vanda Pharmaceuticals |
| Condition | Sleep Wake Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2020-12-09 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 70 participants in total. It began in 2020-12-09 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 participants with DSWPD.
Eligibility Criteria
Inclusion Criteria: * Ability and acceptance to provide written informed consent. * A confirmed clinical diagnosis of Delayed Sleep-Wake Phase Disorder (DSWPD). * Men or women between 18 - 75 years, inclusive. * Body Mass Index (BMI) of ≥ 18 and ≤ 35 kg/m\^2. Exclusion Criteria: * Exacerbation of an existing psychiatric condition that requires change in treatment or intervention in the past 3 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. * A positive test for substances of abuse. * Current tobacco user.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04652882 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Sleep Wake Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04652882 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 70 participants.
Is NCT04652882 currently recruiting?
Yes, NCT04652882 is actively recruiting participants. Contact the research team at clinicaltrials@vandapharma.com for enrollment information.
Where is the NCT04652882 trial being conducted?
This trial is being conducted at Los Angeles, United States, Redwood City, United States, Aurora, United States, Boston, United States and 11 additional locations.
Who is sponsoring the NCT04652882 clinical trial?
NCT04652882 is sponsored by Vanda Pharmaceuticals. The trial plans to enroll 70 participants.