Phase 2
N=58
Efficacy and Safety of ACT-541468 in Elderly Subjects With Insomnia Disorder
Insomnia Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02841709 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2 — -18.9; -32.0; -45.1; -61.4 minutes — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ACT-541468 (Drug); Placebo (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Idorsia Pharmaceuticals Ltd.
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2 |
-18.9; -32.0; -45.1; -61.4; -13.6 | <0.001 sig |
| SECONDARY Change in Mean Latency to Persistent Sleep (LPS) From Baseline to Days 1 and 2 |
-37.92; -44.61; -44.81; -44.88; -33.88 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Signed informed consent prior to any study-mandated procedure.
- Male or female aged ≥ 65 years.
- Body mass index (BMI): 18.5 ≤ BMI (kg/m2 ) 2 × ULN and/or bilirubin > 1.5 × ULN (except known history of Gilbert's syndrome);
- Severe renal impairment (known or defined as estimated creatinine clearance < 30 mL/min);
- History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.
Data sourced from ClinicalTrials.gov (NCT02841709). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.