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

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ClinicalTrials.gov Identifier: NCT03575104
Recruitment Status : Recruiting
First Posted : July 2, 2018
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

Tracking Information
First Submitted Date  ICMJE May 17, 2018
First Posted Date  ICMJE July 2, 2018
Last Update Posted Date August 22, 2019
Actual Study Start Date  ICMJE May 29, 2018
Estimated Primary Completion Date September 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 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) ]
    WASO is the time (min) spent awake after onset of persistent sleep until lights on, as determined by polysomnography (PSG).
  • 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) ]
    WASO is the time (min) spent awake after onset of persistent sleep until lights on, as determined by polysomnography (PSG).
  • 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) ]
    LPS (min) is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 min) 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 (PSG).
  • 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) ]
    LPS (min) is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 min) 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 (PSG).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03575104 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 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: June 20, 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 Suffering From Difficulties to Sleep
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 Phase 3 study is to evaluate the efficacy of 10 mg and 25 mg ACT-541468 on objective sleep parameters in subjects with insomnia disorder.
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 10 mg
    ACT-541468 will be administered as tablets, orally, once daily in the evening.
    Intervention: Drug: ACT-541468
  • Experimental: ACT-541468 25 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 20, 2018)
900
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 18, 2019
Estimated Primary Completion Date September 18, 2019   (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 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.
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: Clinical Trial Disclosure Desk +18566613721 clinical-trials-disclosure@idorsia.com
Listed Location Countries  ICMJE Belgium,   Bulgaria,   Canada,   Czechia,   Finland,   France,   Germany,   Hungary,   Korea, Republic of,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03575104
Other Study ID Numbers  ICMJE ID-078A302
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 August 2019

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