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 groupsLocations
17Austria
Vanda Investigational Site6020, Innsbruck Austria
Vanda Investigational Site1090, Vienna Austria
Germany
Vanda Investigational Site10117, Berlin Germany
Vanda Investigational Site20253, Hamburg Germany
Sponsors and collaborators
Vanda Pharmaceuticals
Lead sponsor
Source ClinicalTrials.gov