An Open-label Study of Azetukalner in Bipolar I or II Depression

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Xenon Pharmaceuticals Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Decision date (initial)

2026-05-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Xenon Pharmaceuticals Inc.

External identifiers

EU CT number

2025-522872-10-00

ClinicalTrials.gov

NCT07217860

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Others, Efficacy, Safety

To assess the safety and tolerability of long-term treatment with 20 mg azetukalner once daily in participants with bipolar depression.

Secondary objectives 1

1. To assess the efficacy of long-term treatment, with azetukalner for the treatment of bipolar depression, To assess the clinician-perceived efficacy and the participant-perceived efficacy of long-term treatment with azetukalner for the treatment of bipolar depression; To assess the efficacy of long-term treatment with azetukalner for the treatment of anhedonia

Conditions and MedDRA coding

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

Study design 1 period

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. 1. Participant successfully completed the treatment period in a Phase 3 antecedent study evaluating azetukalner in participants with bipolar depression
2. 2. Participant provides written informed consent to participate in the study, is able to understand the procedures and study requirements, and agrees to abide by them.
3. 3. Participant is willing to comply with the protocol contraception requirements, as defined in the protocol.

Exclusion criteria 7

1. 1. Participant met any of the withdrawal criteria, discontinued study drug early, or was terminated early from an antecedent study.
2. 2. Participant had any protocol deviations in an antecedent study that, in the opinion of the investigator, would preclude participation in this study.
3. 3. Participant has any medical condition, personal circumstance, or ongoing AE (from an antecedent study) that, in the opinion of the investigator, exposes the participant to unacceptable risk by participating in the study or prevents adherence to the protocol.
4. 4. Female participant who is pregnant, breastfeeding, or planning to become pregnant.
5. 5. Participant is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for the treatment of any medical condition during the study or within 28 days after completion of this study.
6. 6. Participant is judged by the investigator to have a significant risk for self-harm or suicidal behavior during their participation in the study or is considered to be an imminent danger to themself or others.
7. 7. Participant has had an active suicidal plan/intent (answer “yes” on item 4 or 5 in the C-SSRS Suicidal Ideation section) since the last visit, and/or based on the clinical assessment of suicidality risk by the investigator.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Severity and frequency of TEAEs, SAEs, AESIs and ECIs

Secondary endpoints 3

1. Change from baseline in the MADRS total score over time.
2. Change in CGI-S score over time.
3. Change from baseline in the SHAPS total score over time.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Xenon Pharmaceuticals Inc.

Sponsor organisation

Xenon Pharmaceuticals Inc.

Address

3650 Gilmore Way

City

Burnaby

Postcode

V5G 4W8

Country

Canada

Scientific contact point

Organisation

Xenon Pharmaceuticals Inc.

Contact name

Clinical Trial responsible person: Vice President Psychiatry Clinical Development

Public contact point

Organisation

Xenon Pharmaceuticals Inc.

Contact name

Clinical Trial responsible person: Senior Director, Trial Operations

Third parties 14

Locations

4 EU/EEA countries · 21 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 98 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications