Study to Assess the Long Term Safety and Tolerability 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:October 9, 2018
End Date:August 12, 2020
Contact:Clinical Trial Disclosure Desk
Email:clinical-trials-disclosure@idorsia.com
Phone:+41 58 844 0000

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Multi-center, Double-blind, Parallel-group, Randomized, Placebo-controlled, Three Doses, 40-week Extension to Studies ID-078A301 and ID-078A302 to Assess the Long Term Safety and Tolerability of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder

Study to assess the long term safety and tolerability of ACT-541468 in adult and elderly
subjects suffering from difficulties to sleep


Inclusion Criteria:

- Signed informed consent prior to any study-mandated procedure (Visit 1).

- Having completed the DB study treatment and the run-out period of ID-078A301 or
ID‒078A302 (Visit 1).

- For woman of childbearing potential, the following is required:

- Negative urine pregnancy test (EOT of ID-078A301 or ID-078A302 studies)

- Agreement to use the contraception scheme as required by the protocol from Visit
1 up to at least 30 days after EODBT.

Exclusion Criteria:

- Unstable medical condition, significant medical disorder or acute illness, C-SSRS©,
ECG, hematology or biochemistry test results in ID-078A301 and ID-078A302, which in
the opinion of the investigator could affect the subject's safety or interfere with
the study assessments (Visit 1).

- For female subjects: lactating or planning to become pregnant during the duration of
the study (Visit 1).

- Positive urine drug test (for benzodiazepines, barbiturates, cannabinoids, opiates,
amphetamines, or cocaine) or presence of alcohol in exhaled breath as detected by
breathalyzer test (EOT of ID-078A301 or ID-078A302 studies if same day as Visit 1 or
Visit 1 if within 7 days after EOT).
We found this trial at
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Columbia, South Carolina 29201
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400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
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Anniston, Alabama 36207
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Cincinnati, Ohio 45227
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1775 Lexington Avenue
Cincinnati, Ohio 45212
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Clearwater, Florida 33765
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Columbus, Ohio 43213
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801 Monterey Street
Coral Gables, Florida 33134
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Dublin, Ohio 43016
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Fleming Island, Florida 32003
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Flowood, Mississippi 39232
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Hickory, North Carolina 28601
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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
Marvel Clinical Research is a dedicated research site coupled with multi-speciality and family practice doctors...
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Jacksonville, Texas 32216
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1321 Sunset Drive
Johnson City, Tennessee 37604
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La Vista, Nebraska 68128
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Lenexa, Kansas 66214
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Lincoln, California 95648
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640 George Washington Highway
Lincoln, Rhode Island 02865
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Little Rock, Arkansas 72211
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Louisville, Kentucky 40217
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275 Sheraton Boulevard
Macon, Georgia 31210
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Miami, Florida 33126
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Middleburg Heights, Ohio 44130
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Mount Pleasant, South Carolina 29464
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Nampa, Idaho 83686
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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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Newton, Massachusetts 02459
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North Dartmouth, Massachusetts 02747
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Orem, Utah 84058
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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609 West Dyke Road
Rogers, Arkansas 72758
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Saint Petersburg, Florida 33707
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
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Southport, Queensland
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Upland, California 91786
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210 Charlois Boulevard
Winston-Salem, North Carolina 27103
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Winter Park, Florida 32789
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