A Multicenter, Long-term, Open-Label, Safety, Tolerability, and Efficacy Study of Azetukalner in Bipolar I or II Depression

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522872-10-00

Enrollment

Registered

2026-04-28

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-29

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

Conditions

Depressive episodes associated with Bipolar disorder I or II (Bipolar Depression)

Brief summary

Severity and frequency of TEAEs, SAEs, AESIs and ECIs

Detailed description

Change from baseline in the MADRS total score over time., Change in CGI-S score over time., Change from baseline in the SHAPS total score over time.

Interventions

DRUGXPF-010

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Severity and frequency of TEAEs, SAEs, AESIs and ECIs	—

Secondary

Measure	Time frame
Change from baseline in the MADRS total score over time., Change in CGI-S score over time., Change from baseline in the SHAPS total score over time.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 30, 2026