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 |
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
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
71
sites
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17822 Beach Boulevard
huntington beach, California 92647
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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Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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