At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 58 enrolled
Drug / intervention
ACT-541468 +1 moredrug
Likely dose
ACT-541468 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multi-center, Double-blind, Randomized, Placebo-controlled, 5-period, 5-treatment Crossover, Polysomnography Dose-response Study to Assess the Efficacy and Safety of ACT-541468 in Elderly Subjects With Insomnia Disorder
In Brief
A Phase 2 clinical trial evaluating ACT-541468 and Placebo for Insomnia Disorder. Completed, enrolled 58 participants across 10 sites in 2 countries.
Detailed Summary
This study evaluates the dose response of ACT-541468 on the change of wake after sleep onset (WASO) assessed by polysomnography (PSG) on the first 2 days of each treatment period.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia Disorder
CountriesGermany, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 2016
Enrollment StartNov 2016
Primary CompletionMay 2017
Study CompletionJun 2017
TodayJul 2026
First PostedJul 22, 2016
Enrollment StartNov 28, 2016
Primary CompletionMay 31, 2017
Study CompletionJun 29, 2017
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 9.9 years ago
Interventions
ACT-541468drug
Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg
Placebodrug
Capsules for oral administration matching the ACT-541468 capsules