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

Use our guide to learn which trials are right for you!

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
36
sites
210 Charlois Boulevard
Winston-Salem, North Carolina 27103
Phone: 608-664-9000
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
Arlington, Texas 76015
Phone: 817-690-6331
?
mi
from
Arlington, TX
Click here to add this to my saved trials
Atlanta, Georgia 30342
Phone: 404-851-9934
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Austin, Texas 78731
Phone: 512-380-9925
?
mi
from
Austin, TX
Click here to add this to my saved trials
Brugge,
Phone: +32 50 452306
?
mi
from
Brugge,
Click here to add this to my saved trials
Cerritos, California 90703
Phone: 562-924-8880
?
mi
from
Cerritos, CA
Click here to add this to my saved trials
1775 Lexington Avenue
Cincinnati, Ohio 45212
Phone: 513-721-3868
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Columbus, Ohio 43213
Phone: 614-501-6164
?
mi
from
Columbus, OH
Click here to add this to my saved trials
801 Monterey Street
Coral Gables, Florida 33134
Phone: 305-445-5637
?
mi
from
Coral Gables, FL
Click here to add this to my saved trials
Cordova, Tennessee 38018
Phone: 901-261-3500
?
mi
from
Cordova, TN
Click here to add this to my saved trials
DeSoto, Texas 75115
Phone: 503-276-6624
?
mi
from
DeSoto, TX
Click here to add this to my saved trials
Dublin, Ohio 43017
?
mi
from
Dublin, OH
Click here to add this to my saved trials
Fleming Island, Florida 32003
Phone: 904-621-0390
?
mi
from
Fleming Island, FL
Click here to add this to my saved trials
Flowood, Mississippi 39232
Phone: 601-420-5810
?
mi
from
Flowood, MS
Click here to add this to my saved trials
Garden City, New York 11530
Phone: 208-346-8900
?
mi
from
Garden City, NY
Click here to add this to my saved trials
Glendale, Arizona 85306
Phone: 602-258-4951
?
mi
from
Glendale, AZ
Click here to add this to my saved trials
Hickory, North Carolina 28601
Phone: 208-346-8900
?
mi
from
Hickory, NC
Click here to add this to my saved trials
Jacksonville, Texas 32216
Phone: 904-730-0101
?
mi
from
Jacksonville, TX
Click here to add this to my saved trials
Lafayette, Colorado 80026
Phone: 480-390-4537
?
mi
from
Lafayette, CO
Click here to add this to my saved trials
Lenexa, Kansas 66214
Phone: 913-827-4202
?
mi
from
Lenexa, KS
Click here to add this to my saved trials
Lincoln, Florida 95648
Phone: 916-434-8230
?
mi
from
Lincoln, FL
Click here to add this to my saved trials
Little Rock, Arkansas 72205
Phone: 501-622-8499
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Little Rock, Arkansas 72211
Phone: 501-221-8681
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
275 Sheraton Boulevard
Macon, Georgia 31210
Phone: 478-745-5779
?
mi
from
Macon, GA
Click here to add this to my saved trials
Middleburg Heights, Ohio 44130
Phone: 440-725-9363
?
mi
from
Middleburg Heights, OH
Click here to add this to my saved trials
Nampa, Idaho 83686
Phone: 208-884-2922
?
mi
from
Nampa, ID
Click here to add this to my saved trials
Newton, Massachusetts 02459
Phone: 617-581-6403
?
mi
from
Newton, MA
Click here to add this to my saved trials
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...
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Riverside, California 92503
Phone: 858-278-3647
?
mi
from
Riverside, CA
Click here to add this to my saved trials
Saint Petersburg, Florida 33707
Phone: 727-360-0853
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
San Diego, California 92103
Phone: 619-294-4302
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Marcos, California 92078
Phone: 858-278-3647
?
mi
from
San Marcos, CA
Click here to add this to my saved trials
Santa Monica, California 90404
Phone: 310-586-0843
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
Tomball, Texas 77375
Phone: 281-517-0550
?
mi
from
Tomball, TX
Click here to add this to my saved trials
Upland, California 91786
Phone: 909-981-5321
?
mi
from
Upland, CA
Click here to add this to my saved trials
Wooster, Ohio 44691
Phone: 330-345-2459
?
mi
from
Wooster, OH
Click here to add this to my saved trials