Study to Assess the Efficacy and Safety of ACT-541468 in Adult and Elderly Subjects Suffering From Difficulties to Sleep

• Status: Completed
• Trial end date: 2020-05-14
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this Phase 3 study is to evaluate the efficacy of 10 mg and 25 mg ACT-541468 on objective sleep parameters in subjects with insomnia disorder.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

Criteria

Inclusion Criteria:

• Signed informed consent prior to any study-mandated procedure;

• Male or female aged ≥ 18 years;

• Insomnia disorder according to DSM-5 criteria;

• Insomnia Severity Index score ≥ 15;

• Insufficient sleep quantity as collected subjectively in the sleep diary and validated objectively by polysomnography;

• Women of childbearing potential must have a negative and urine pregnancy test and use the contraception scheme up to at least 30 days after last study treatment intake.

Exclusion Criteria:

• Body mass index below 18.5 or above 40.0 kg/m2;

• Any lifetime history of of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, narcolepsy, or apnea/hypopnea;

• Cognitive behavioral therapy (CBT) only allowed if, the treatment started at least 1 month prior to Visit 3 and the subject agrees to continue this CBT throughout the study;

• Self-reported usual daytime napping ≥ 1 hour per day and ≥ 3 days per week;

• Acute or unstable psychiatric conditions diagnosed by the Mini International Neuropsychiatric Interview;

• Mini Mental State Examination (MMSE) score < 25 in subjects ≥ 50 years;

• For female subjects: pregnant, lactating or planning to become pregnant during projected duration of the study;

• 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.