Study to assess the long term safety and tolerability of ACT-541468 in adult and elderly subjects suffering from difficulties to sleep

Phase 1

• Conditions: Insomnia disorder; MedDRA version: 20.0Level: PTClassification code 10022437Term: InsomniaSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-004644-38-CZ
• Lead Sponsor: Idorsia Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-14
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1260

Inclusion Criteria

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

Exclusion Criteria

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 pregnantduring 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
Main Objective: The objective of this extension study is to assess the long-term safety and tolerability of 10, 25 and 50 mg ACT?541468.;Secondary Objective: Not applicable.;Primary end point(s): • Serious adverse events (SAEs)<br>• Treatment-emergent adverse events (TEAEs)<br>;Timepoint(s) of evaluation of this end point: From signed ICF up to 30 days after last dose of DB study treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.