An open label, single arm, extension trial to examine long-term safety of Iclepertin once daily in patients with schizophrenia who have completed previous Iclepertin Phase III trials.(CONNEX-X)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511560-93-00

Acronym

1346-0014

Enrollment

396

Registered

2024-06-20

Start date

2022-03-29

Completion date

2025-01-15

Last updated

2024-10-28

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

Conditions

Schizophrenia

Brief summary

Occurrence of treatment emergent adverse events (TEAEs) throughout the extension study

Detailed description

Change from baseline in Clinical Global Impressions – Severity (CGI-S) to end of treatment (EOT), Change from baseline in Hb to EOT

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Occurrence of treatment emergent adverse events (TEAEs) throughout the extension study	—

Secondary

Measure	Time frame
Change from baseline in Clinical Global Impressions – Severity (CGI-S) to end of treatment (EOT), Change from baseline in Hb to EOT	—

Countries

Austria, Belgium, Bulgaria, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden

Outcome results