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
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials