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).
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3100 Duraleigh Rd
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