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Tasimelteon in Delayed Sleep-Wake Phase Disorder (DSWPD)
NCT04652882Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2020
- Primary completion
- Sep 2026
- Countries
- 3
- Sponsor
- Vanda Pharmaceuticals Inc.
- Modality
- Small Molecules
- Drugs
- tasimelteon
- Conditions
- delayed sleep-wake phase disorder (DSPD)
01
Overview
Phase 3, randomised, double-blind trial in delayed sleep-wake phase disorder (DSPD) comparing Tasimelteon with Placebo (2 arms). Primary endpoint: Change in Sleep Onset at 28 days. Started Dec 2020; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Tasimelteon
Tasimelteon oral capsule
Placebo
Placebo oral capsule
03
Who it enrols
Adults aged 18-75 with a confirmed diagnosis of DSWPD and BMI 18-35 kg/m^2, excluding those with recent psychiatric exacerbations, major surgery/illness, pregnancy, substance abuse, or current tobacco use.
04
Endpoints
Primary
Change in Sleep Onset
Secondary
Change in nighttime objective sleep-wake parameters
Change in nighttime subjective sleep-wake parameters
Adverse Events
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