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

NCT02841709 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2020-04-24

Study results available
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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.

Conditions

  • Insomnia Disorder

Interventions

DRUG

ACT-541468

Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg

DRUG

Placebo

Capsules for oral administration matching the ACT-541468 capsules

Sponsors & Collaborators

  • Idorsia Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Idorsia Pharmaceuticals Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-28
Primary Completion
2017-05-31
Completion
2017-06-29

Countries

  • United States
  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT02841709 on ClinicalTrials.gov