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Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep

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ClinicalTrials.gov Identifier: NCT03575104
Recruitment Status : Completed
First Posted : July 2, 2018
Results First Posted : March 25, 2022
Last Update Posted : March 25, 2022
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Insomnia Disorder Drug: Daridorexant Other: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 924 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, Parallel-group, Polysomnography Study to Assess the Efficacy and Safety of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder
Actual Study Start Date : May 29, 2018
Actual Primary Completion Date : April 9, 2020
Actual Study Completion Date : May 14, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Daridorexant 10 mg Drug: Daridorexant
Daridorexant will be administered as tablets, orally, once daily in the evening.
Experimental: Daridorexant 25 mg Drug: Daridorexant
Daridorexant will be administered as tablets, orally, once daily in the evening.
Placebo Comparator: Placebo Other: Placebo
Matching placebo will be administered as tablets, orally, once daily in the evening.


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance) [ Time Frame: From baseline to Month 1 (i.e. for up to 1 month) ]
    "Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.

  2. Change From Baseline to Month 3 in Wake After Sleep Onset (WASO) [ Time Frame: From baseline to Month 3 (i.e. for up to 3 months) ]
    "Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.

  3. Change From Baseline to Month 1 in Latency to Persistent Sleep (LPS) (Sleep Onset) [ Time Frame: From baseline to Month 1 (i.e. for up to 1 month) ]
    "Latency to Persistent Sleep" is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-awake, i.e., epochs scored as either sleep stage 1 (S1), sleep stage 2 (S2), sleep stage 3 (slow wave sleep) or REM, as determined by polysomnography.

  4. Change From Baseline to Month 3 in Latency to Persistent Sleep (LPS) [ Time Frame: From baseline to Month 3 (i.e. for up to 3 months) ]
    "Latency to Persistent Sleep" is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-awake, i.e., epochs scored as either sleep stage 1 (S1), sleep stage 2 (S2), sleep stage 3 (slow wave sleep) or REM, as determined by polysomnography.


Secondary Outcome Measures :
  1. Change From Baseline to Month 1 in the Subjective Total Sleep Time (sTST) [ Time Frame: From baseline to Month 1 (i.e. for up to 1 month) ]
    "Subjective Total Sleep Time" is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in the subjective Total Sleep Time. A negative change from baseline indicates a decrease in subjective Total Sleep Time.

  2. Change From Baseline to Month 3 in the Subjective Total Sleep Time (sTST) [ Time Frame: From baseline to Month 3 (i.e. for up to 3 months) ]
    Subjective Total Sleep Time is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in the subjective Total Sleep Time. A negative change from baseline indicates a decrease in subjective Total Sleep Time.

  3. Change From Baseline to Month 1 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Sleepiness Domain Score [ Time Frame: From baseline to Month 1 (i.e. for up to 1 month) ]
    The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a validated patient reported outcome instrument comprising 14 items (each using a numeric rating scale from 0 to 10) grouped into three domains (i.e., sleepiness, mood, and alert/cognition) reflecting daytime impairment of insomnia. The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.

  4. Change From Baseline to Month 3 in IDSIQ Sleepiness Domain Score [ Time Frame: From baseline to Month 3 (i.e. for up to 3 months) ]
    The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a validated patient reported outcome instrument comprising 14 items (each using a numeric rating scale from 0 to 10) grouped into three domains (i.e., sleepiness, mood, and alert/cognition) reflecting daytime impairment of insomnia. The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent prior to any study-mandated procedure;
  • Male or female aged ≥ 18 years;
  • Insomnia disorder according to DSM-5 criteria;
  • Insomnia Severity Index score ≥ 15;
  • Insufficient sleep quantity as collected subjectively in the sleep diary and validated objectively by polysomnography;
  • Women of childbearing potential must have a negative and urine pregnancy test and use the contraception scheme up to at least 30 days after last study treatment intake.

Exclusion Criteria:

  • Body mass index below 18.5 or above 40.0 kg/m2;
  • Any lifetime history of of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, narcolepsy, or apnea/hypopnea;
  • Cognitive behavioral therapy (CBT) only allowed if, the treatment started at least 1 month prior to Visit 3 and the subject agrees to continue this CBT throughout the study;
  • Self-reported usual daytime napping ≥ 1 hour per day and ≥ 3 days per week;
  • Acute or unstable psychiatric conditions diagnosed by the Mini International Neuropsychiatric Interview;
  • Mini Mental State Examination (MMSE) score < 25 in subjects ≥ 50 years;
  • For female subjects: pregnant, lactating or planning to become pregnant during projected duration of the study;
  • 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.
Contacts and Locations
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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): NCT03575104


Locations
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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] November 8, 2018
Statistical Analysis Plan  [PDF] June 12, 2020

More Information
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Publications of Results:

Other Publications:

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Responsible Party: Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT03575104    
Other Study ID Numbers: ID-078A302
First Posted: July 2, 2018    Key Record Dates
Results First Posted: March 25, 2022
Last Update Posted: March 25, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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