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



Status:Recruiting
Conditions:Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:May 29, 2018
End Date:November 18, 2019
Contact:Clinical Trial Disclosure Desk
Email:clinical-trials-disclosure@idorsia.com
Phone:+41 58 844 0000

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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

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.


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.
We found this trial at
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Jacksonville, Texas 32216
Phone: 904-730-0101
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Arlington, Texas 76015
Phone: 817-690-6331
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Atlanta, Georgia 30342
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Austin, Texas 78731
Phone: 512-380-9925
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Brugge,
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Cerritos, California 90703
Phone: 562-924-8880
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1775 Lexington Avenue
Cincinnati, Ohio 45212
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Columbus, Ohio 43213
Phone: 614-501-6164
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801 Monterey Street
Coral Gables, Florida 33134
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Cordova, Tennessee 38018
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DeSoto, Texas 75115
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Dublin, Ohio 43017
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Fleming Island, Florida 32003
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Flowood, Mississippi 39232
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Garden City, New York 11530
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Glendale, Arizona 85306
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Hickory, North Carolina 28601
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Lafayette, Colorado 80026
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Lenexa, Kansas 66214
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Lincoln, Florida 95648
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Little Rock, Arkansas 72205
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Little Rock, Arkansas 72211
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275 Sheraton Boulevard
Macon, Georgia 31210
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Middleburg Heights, Ohio 44130
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Nampa, Idaho 83686
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Newton, Massachusetts 02459
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Phone: 919-781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Riverside, California 92503
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Saint Petersburg, Florida 33707
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San Diego, California 92103
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San Marcos, California 92078
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Santa Monica, California 90404
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Tomball, Texas 77375
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Upland, California 91786
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210 Charlois Boulevard
Winston-Salem, North Carolina 27103
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Wooster, Ohio 44691
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