Trials / Completed
CompletedNCT02841709
Efficacy and Safety of ACT-541468 in Elderly Subjects With Insomnia Disorder
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 58 (actual)
- Sponsor
- Idorsia Pharmaceuticals Ltd. · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The study consists of 3 phases: a screening phase, a double-blind treatment phase consisting of 5 periods, and a safety follow-up phase. Safety is monitored throughout the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ACT-541468 | Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg |
| DRUG | Placebo | Capsules for oral administration matching the ACT-541468 capsules |
Timeline
- Start date
- 2016-11-28
- Primary completion
- 2017-05-31
- Completion
- 2017-06-29
- First posted
- 2016-07-22
- Last updated
- 2020-04-24
- Results posted
- 2020-04-24
Locations
10 sites across 2 countries: United States, Germany
Source: ClinicalTrials.gov record NCT02841709. Inclusion in this directory is not an endorsement.