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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02839200
Recruitment Status : Completed
First Posted : July 20, 2016
Results First Posted : April 2, 2020
Last Update Posted : April 13, 2020
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Insomnia Disorder Drug: ACT-541468 5 mg Drug: ACT-541468 10 mg Drug: ACT-541468 25 mg Drug: Zolpidem Drug: Placebo 1 Drug: Placebo 2 Phase 2

Detailed Description:
This study consists of the following phases: screening phase; double-blind treatment phase; safety follow-up phase. Safety is monitored throughout the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-center, Double-blind, Randomized, Placebo-controlled, Active-reference, Parallel-group, Polysomnography Dose-response Study to Assess the Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder
Actual Study Start Date : October 4, 2016
Actual Primary Completion Date : April 12, 2017
Actual Study Completion Date : June 20, 2017

Arm Intervention/treatment
Experimental: ACT-541468 5 mg
Each subject receives one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
Drug: ACT-541468 5 mg
Capsule for oral administration containing ACT-541468 at a strength of 5 mg

Drug: Placebo 1
Placebo capsules matching ACT-541468 capsules

Experimental: ACT-541468 10 mg
Each subject receives one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
Drug: ACT-541468 10 mg
Capsule for oral administration containing ACT-541468 at a strength of 10 mg

Drug: Placebo 1
Placebo capsules matching ACT-541468 capsules

Experimental: ACT-541468 25 mg
Each subject receives one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks
Drug: ACT-541468 25 mg
Capsule for oral administration containing ACT-541468 at a strength of 25 mg

Drug: Placebo 1
Placebo capsules matching ACT-541468 capsules

Experimental: ACT-541468 50 mg
Each subject receives two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks
Drug: ACT-541468 25 mg
Capsule for oral administration containing ACT-541468 at a strength of 25 mg

Active Comparator: Zolpidem
Each subject receives one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks
Drug: Zolpidem
Over-encapsulated zolpidem tablet at a strength of 10 mg

Drug: Placebo 2
Placebo capsules matching over-encapsulated zolpidem

Placebo Comparator: Placebo
Each subject receives two placebo capsules, once daily in the evening for 4 weeks
Drug: Placebo 1
Placebo capsules matching ACT-541468 capsules




Primary Outcome Measures :
  1. Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2 [ Time Frame: Baseline and Days 1&2 ]
    WASO is the time in minutes spent awake after onset of persistent sleep until lights on as determined by polysomnography (PSG)


Secondary Outcome Measures :
  1. Change in Latency to Persistent Sleep (LPS) From Baseline to Days 1 and 2 [ Time Frame: Baseline and Days 1&2 ]
    LPS is the duration of time in minutes from lights off to persistent sleep onset as determined by PSG

  2. Change in Subjective Latency to Sleep Onset (sLSO) From Baseline to Week 4 [ Time Frame: Baseline and Week 4 ]
    sLSO is the self-reported time to fall asleep, as reported in the sleep diary

  3. Change in Subjective Wake After Sleep Onset (sWASO) From Baseline to Week 4 [ Time Frame: Baseline and Week 4 ]
    sWASO is the self-reported time spent awake after sleep onset as reported in the sleep diary.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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) < 32.0.
  • Insomnia disorder according to DSM-5 criteria.
  • Insufficient sleep quantity as collected subjectively in the sleep diary and validated objectively by polysomnography.
  • Insomnia Severity Index score ≥ 15.

Principal exclusion Criteria:

  • Any current history of sleep disorder other than insomnia, or any lifetime history of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, or narcolepsy.
  • Self-reported usual daytime napping ≥ 1 hour per day, and ≥ 3 days per week.
  • Caffeine consumption ≥ 600 mg per day.
  • Shift work within 2 weeks prior to the screening visit, or planned shift work during study.
  • Travel ≥ 3 time zones within 1 week prior to the screening visit, or planned travel > 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02839200


Locations
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United States, California
Investigator Site
Santa Monica, California, United States, 90404
Investigator Site
Upland, California, United States, 91786
United States, Florida
Investigator Site
Brandon, Florida, United States, 33511
Investigator Site
Clearwater, Florida, United States, 33765
Investigator Site
Coral Gables, Florida, United States, 33134
Investigator Site
DeLand, Florida, United States, 32720
Investigator Site
Hollywood, Florida, United States, 33024
Investigator Site
Miami, Florida, United States, 33143
United States, Georgia
Investigator Site
Atlanta, Georgia, United States, 30342
United States, Illinois
Investigator Site
Chicago, Illinois, United States, 60634
United States, Indiana
Investigator Site
Indianapolis, Indiana, United States, 46250
United States, Michigan
Investigator Site
Novi, Michigan, United States, 48377
United States, Nevada
Investigator Site
Las Vegas, Nevada, United States, 89104
United States, New York
Investigator Site
New York, New York, United States, 10019
United States, Ohio
Investigator Site
Cincinnati, Ohio, United States, 45255
Germany
Investigator Site
Berlin, Germany, 10115
Investigator Site
Berlin, Germany, 10117
Investigator Site
Berlin, Germany, 12203
Investigator Site
Dresden, Germany, 01069
Investigator Site
Hamburg, Germany, 20251
Investigator Site
Hamburg, Germany, 20253
Investigator Site
Hannover, Germany, 30159
Investigator Site
Schwerin, Germany, 19053
Investigator Site
Schwerin, Germany, 19055
Hungary
Investigator Site
Budapest, Hungary, 1134
Investigator Site
Szeged, Hungary, 6725
Investigator Site
Törökbálint, Hungary, 2045
Israel
Investigator Site
Beer Sheva, Israel, 84101
Investigator Site
Haifa, Israel, 31096
Spain
Investigator Site
Barcelona, Spain, 08017
Investigator Site
Barcelona, Spain, 08035
Investigator Site
Madrid, Spain, 28036
Investigator Site
Zaragoza, Spain, 50015
Sweden
Investigator Site
Göteborg, Sweden, 413 90
Investigator Site
Örebro, Sweden, 701 85
Sponsors and Collaborators
Idorsia Pharmaceuticals Ltd.
Investigators
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Study Director: Clinical Trials Idorsia Pharmaceuticals Ltd.
  Study Documents (Full-Text)

Documents provided by Idorsia Pharmaceuticals Ltd.:
Study Protocol  [PDF] December 16, 2016
Statistical Analysis Plan  [PDF] July 3, 2017

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT02839200    
Other Study ID Numbers: AC-078A201
First Posted: July 20, 2016    Key Record Dates
Results First Posted: April 2, 2020
Last Update Posted: April 13, 2020
Last Verified: April 2020
Keywords provided by Idorsia Pharmaceuticals Ltd.:
Insomnia
Polysomnography
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Zolpidem
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action