Phase 2
N=360
Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder
Insomnia Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02839200 ↗Enrolled (actual)
360
Serious AEs
0.8%
Results posted
Apr 2020
Primary outcome: Primary: Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2 — -28.4; -32.3; -37.7; -47.1 minutes — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ACT-541468 5 mg (Drug); ACT-541468 10 mg (Drug); ACT-541468 25 mg (Drug); Zolpidem (Drug); Placebo 1 (Drug); Placebo 2 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Idorsia Pharmaceuticals Ltd.
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2 |
-28.4; -32.3; -37.7; -47.1; -29.9; -21.4 | <0.001 sig |
| SECONDARY Change in Latency to Persistent Sleep (LPS) From Baseline to Days 1 and 2 |
-26.88; -29.31; -36.14; -36.41; -45.14; -22.02 | — |
| SECONDARY Change in Subjective Latency to Sleep Onset (sLSO) From Baseline to Week 4 |
-13.38; -21.07; -15.50; -23.65; -19.98; -16.32 | — |
| SECONDARY Change in Subjective Wake After Sleep Onset (sWASO) From Baseline to Week 4 |
-31.32; -24.35; -29.8; -35.45; -29.08; -23.61 | — |
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.
Eligibility Criteria
Principal inclusion Criteria:
- Signed informed consent prior to any study-mandated procedure.
- Male or female aged 18-64 years (inclusive).
- Women of childbearing potential must have negative pregnancy tests and use reliable methods of contraception up to 30 days after EOT.
- Body mass index (BMI): 18.5 ≤ BMI (kg/m2) or= 3 time zones during study.
- Hematology or biochemistry test results deviating from the normal range to a clinically relevant extent as per judgment of the Investigator.
- AST and/or ALT > 2 × ULN and/or direct 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 (NCT02839200). 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.