Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorVanda Pharmaceuticals
About this trial
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
Qualifiers
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/m².
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Tasimelteon
- Placebo
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov