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Trial record 8 of 83 for:    ZOLPIDEM AND Wake

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

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ClinicalTrials.gov Identifier: NCT02839200
Recruitment Status : Completed
First Posted : July 20, 2016
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

Brief Summary:
The primary objective of this study is to assess the effect of ACT-541468 on a measure of sleep maintenance (Wake after Sleep Onset or WASO) by polysomnography in subjects with insomnia disorder.

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.



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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


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Sponsors and Collaborators
Idorsia Pharmaceuticals Ltd.
Investigators
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Study Director: Sara Mangialaio Actelion

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Responsible Party: Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT02839200     History of Changes
Other Study ID Numbers: AC-078A201
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Keywords provided by Idorsia Pharmaceuticals Ltd.:
Insomnia
Polysomnography
Additional relevant MeSH terms:
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Sleep Wake Disorders
Zolpidem
Sleep Initiation and Maintenance Disorders
Disease
Pathologic Processes
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Mental Disorders
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