MedTrace Logo

Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder

NCT03545191 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 930

Last updated 2022-03-25

Study results available
· View outcomes & findings →

Summary

The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.

Conditions

  • Insomnia Disorder

Interventions

DRUG

Daridorexant 25 mg

Daridorexant will be administered as tablets, orally, once daily in the evening.

DRUG

Daridorexant 50 mg

Daridorexant will be administered as tablets, orally, once daily in the evening.

OTHER

Placebo

Matching placebo will be administered as tablets, orally, once daily in the evening.

Sponsors & Collaborators

  • Idorsia Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Idorsia Pharmaceuticals Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-04
Primary Completion
2020-01-25
Completion
2020-02-25
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Denmark
  • Germany
  • Italy
  • Poland
  • Serbia
  • Spain
  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03545191 on ClinicalTrials.gov