At a glance
ClinicalIndex Comparison Record- ✓Age 18-64 years (inclusive)
- ✓Insomnia disorder diagnosed by DSM-5 criteria
- ✓Insomnia Severity Index score ≥15
- ✓Objective sleep insufficiency confirmed by polysomnography
- ✕Any current sleep disorder other than insomnia, or lifetime history of breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, REM behavior disorder, or narcolepsy
- ✕Daytime napping ≥1 hour per day on ≥3 days per week
- ✕Caffeine consumption ≥600 mg per day
- ✕Shift work within 2 weeks prior to screening or planned during study
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multi-center, Double-blind, Randomized, Placebo-controlled, Active-reference, Parallel-group, Polysomnography Dose-response Study to Assess the Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder
In Brief
A Phase 2 clinical trial evaluating ACT-541468 5 mg, ACT-541468 10 mg, and 4 other interventions for Insomnia Disorder. Completed, enrolled 360 participants across 35 sites in 6 countries.
Detailed Summary
This study evaluates the dose response of ACT-541468 on the change of WASO from baseline to Days 1 and 2, assessed by PSG.
Study Details
Timeline
Interventions
Capsule for oral administration containing ACT-541468 at a strength of 5 mg
Capsule for oral administration containing ACT-541468 at a strength of 10 mg
Capsule for oral administration containing ACT-541468 at a strength of 25 mg
Over-encapsulated zolpidem tablet at a strength of 10 mg
Placebo capsules matching ACT-541468 capsules
Placebo capsules matching over-encapsulated zolpidem