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Trial record 1 of 1 for:    NCT03545191
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Study to Assess the Efficacy and Safety of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder

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ClinicalTrials.gov Identifier: NCT03545191
Recruitment Status : Completed
First Posted : June 4, 2018
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

Tracking Information
First Submitted Date  ICMJE May 22, 2018
First Posted Date  ICMJE June 4, 2018
Last Update Posted Date June 25, 2020
Actual Study Start Date  ICMJE June 4, 2018
Actual Primary Completion Date January 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2018)
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2018)
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 22, 2018)
Number of subjects with (serious) adverse events [ Time Frame: SAE and AE reporting and follow-up: all SAEs and AEs from signed ICF up to 30 days after double-blind study drug discontinuation. For up to approx. 132 to 154 days in total. ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study to Assess the Efficacy and Safety of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder
Official Title  ICMJE 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
Brief Summary The main purpose of this study is to assess efficacy and safety of ACT-541468 in subjects with insomnia disorder. Efficacy will be evaluated on sleep onset and sleep maintenance.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Insomnia Disorder
Intervention  ICMJE
  • Drug: ACT-541468
    Administered orally as tablets.
  • Other: Placebo
    Administered orally as tablets.
Study Arms  ICMJE
  • Experimental: ACT-541468 25 mg
    ACT-541468 will be administered as tablets, orally, once daily in the evening.
    Intervention: Drug: ACT-541468
  • Experimental: ACT-541468 50 mg
    ACT-541468 will be administered as tablets, orally, once daily in the evening.
    Intervention: Drug: ACT-541468
  • Placebo Comparator: Placebo
    Matching placebo will be administered as tablets, orally, once daily in the evening.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 27, 2020)
930
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2018)
900
Actual Study Completion Date  ICMJE February 25, 2020
Actual Primary Completion Date January 25, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Denmark,   Germany,   Italy,   Poland,   Serbia,   Spain,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03545191
Other Study ID Numbers  ICMJE ID-078A301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Idorsia Pharmaceuticals Ltd.
Study Sponsor  ICMJE Idorsia Pharmaceuticals Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Idorsia Pharmaceuticals Ltd.
PRS Account Idorsia Pharmaceuticals Ltd.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP