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Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)

ConditionsSleep Wake DisordersSleep Disorders, Circadian RhythmChronobiology Disorders
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Tasimelteon

    Drug

    oral capsule

  • Placebo

    Drug

    oral capsule

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: TasimelteonExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Sleep Onset over the treatment period, as measured by sleep diary.

Time frame
28 days

Secondary outcomes

1

Change in nighttime objective sleep-wake parameters such as sleep time, as measured by actigraphy.

Time frame
28 days
2

Change in nighttime subjective sleep-wake parameters such as sleep time, as measured by sleep diary.

Time frame
28 days
3

Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs).

Time frame
28 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanda Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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