Study to Assess the Efficacy and Safety of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder



Status:Recruiting
Conditions:Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:June 4, 2018
End Date:November 1, 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 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.


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.
We found this trial at
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Clearwater, Florida 33765
Phone: 727-210-4606
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400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
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Adelaide,
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Anniston, Alabama 36207
Phone: 256-236-0055
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Baytown, Texas 77512
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Birmingham, Alabama 35243
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Brandon, Florida 33511
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Chevy Chase, Maryland 20815
Phone: 301-654-5665
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Cincinnati, Ohio 45227
Phone: 513-721-3868
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Columbia, South Carolina 29201
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Hialeah, Florida 33012
Phone: 786-454-2950
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7261 Sheridan Street
Hollywood, Florida 33024
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9801 Kincey Avenue
Huntersville, North Carolina 28078
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17822 Beach Boulevard
huntington beach, California 92647
(714) 375-5970
Phone: 714-375-5970
Marvel Clinical Research is a dedicated research site coupled with multi-speciality and family practice doctors...
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1321 Sunset Drive
Johnson City, Tennessee 37604
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La Vista, Nebraska 68128
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Lake Worth, Florida 33467
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Las Vegas, Nevada 89104
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640 George Washington Highway
Lincoln, Rhode Island 02865
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Little Rock, Arkansas 72211
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Long Beach, California 90806
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Louisville, Kentucky 40217
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Miami, Florida 33126
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Michigan City, Indiana 46360
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1020 Medical Park Avenue
New Bern, North Carolina 28562
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423 W 55th St, 4th floor
New York, New York 10019
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North Dartmouth, Massachusetts 02747
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Orem, Utah 84058
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609 West Dyke Road
Rogers, Arkansas 72758
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Salem, Oregon 97301
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San Antonio, Texas 78229
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Phone: 206-386-4744
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Winter Park, Florida 32789
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