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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004644-38-DK

Enrollment

1260

Registered

2018-08-03

Start date

2018-10-30

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia disorder MedDRA version: 20.0 Level: PT Classification code 10022437 Term: Insomnia System Organ Class: 10037175 - Psychiatric disorders

Interventions

Product Name: - Product Code: ACT-541468 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: - Current Sponsor code: ACT-541468 Other descriptive name: ACT-541468 Concentration unit: mg milli

Eligibility

Sex/Gender

All

Inclusion criteria

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

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).

Design outcomes

Primary

Measure	Time frame
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) • Treatment-emergent adverse events (TEAEs) ;Timepoint(s) of evaluation of this end point: From signed ICF up to 30 days after last dose of DB study treatment.	—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.	—

Countries

Australia, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Korea, Republic of, Poland, Serbia, Spain, Sweden, Switzerland, United States

Contacts

Public ContactClinical trials disclosure desk

Idorsia Pharmaceuticals Ltd

clinical-trials-disclosure@idorsia.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026