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Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder

NCT02839200 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2020-04-13

Study results available
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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.

Conditions

  • Insomnia Disorder

Interventions

DRUG

ACT-541468 5 mg

Capsule for oral administration containing ACT-541468 at a strength of 5 mg

DRUG

ACT-541468 10 mg

Capsule for oral administration containing ACT-541468 at a strength of 10 mg

DRUG

ACT-541468 25 mg

Capsule for oral administration containing ACT-541468 at a strength of 25 mg

DRUG

Zolpidem

Over-encapsulated zolpidem tablet at a strength of 10 mg

DRUG

Placebo 1

Placebo capsules matching ACT-541468 capsules

DRUG

Placebo 2

Placebo capsules matching over-encapsulated zolpidem

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
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-04
Primary Completion
2017-04-12
Completion
2017-06-20

Countries

  • United States
  • Germany
  • Hungary
  • Israel
  • Spain
  • Sweden

Study Locations

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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 NCT02839200 on ClinicalTrials.gov