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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 : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

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.

Condition or disease Intervention/treatment Phase
Insomnia Disorder Drug: ACT-541468 Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 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
Estimated Primary Completion Date : October 18, 2019
Estimated Study Completion Date : November 18, 2019

Arm Intervention/treatment
Experimental: ACT-541468 10 mg
ACT-541468 will be administered as tablets, orally, once daily in the evening.
Drug: ACT-541468
Administered orally as tablets.

Experimental: ACT-541468 25 mg
ACT-541468 will be administered as tablets, orally, once daily in the evening.
Drug: ACT-541468
Administered orally as tablets.

Placebo Comparator: Placebo
Matching placebo will be administered as tablets, orally, once daily in the evening.
Other: Placebo
Administered orally as tablets.




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) ]
    WASO is the time (min) spent awake after onset of persistent sleep until lights on, as determined by polysomnography (PSG).

  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) ]
    WASO is the time (min) spent awake after onset of persistent sleep until lights on, as determined by polysomnography (PSG).

  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) ]
    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).

  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) ]
    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).


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) ]
  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) ]
  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) ]
  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) ]

Other Outcome Measures:
  1. 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. ]


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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.

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


Contacts
Contact: Clinical Trial Disclosure Desk +41 58 844 0000 clinical-trials-disclosure@idorsia.com

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Sponsors and Collaborators
Idorsia Pharmaceuticals Ltd.
Investigators
Study Director: Clinical Trials Idorsia Pharmaceuticals Ltd.

Responsible Party: Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT03575104     History of Changes
Other Study ID Numbers: ID-078A302
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders