Study to assess the long term safety and tolerability of ACT-541468 in adult and elderly subjects suffering from difficulties to sleep.
- Conditions
- Insomnia disorderMedDRA version: 20.0Level: PTClassification code 10022437Term: InsomniaSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2017-004644-38-IT
- Lead Sponsor
- IDORSIA PHARMACEUTICALS LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 804
1. Signed informed consent prior to any study-mandated procedure (Visit 1).
2. Having completed the DB study treatment and the run-out period of ID-078A301 or ID¿078A302 (Visit 1).
3. 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 756
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 504
1. 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).
2. For female subjects: lactating or planning to become pregnant during the duration of the study (Visit 1).
3. Positive urine drug test (for benzodiazepines, barbiturates, cannabinoids, opiates, amphetamines, or cocaine) (Visit 1).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method