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 su

IDORSIA PHARMACEUTICALS LTD0 个研究点目标入组 804 人开始时间: 2021年9月10日最近更新: 2022年4月4日

研究概览

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•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
•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).

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