An Open-label Study of Azetukalner in Major Depressive Disorder

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]

Trial duration

4 Jun 2026 → ongoing

Decision date (initial)

2026-03-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Xenon Pharmaceuticals Inc.

External identifiers

EU CT number

2025-523618-10-00

ClinicalTrials.gov

NCT03748446

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety, Others

To assess the safety and tolerability of long‑term treatment with azetukalner in participants with MDD.

Secondary objectives 4

1. To assess the efficacy of long‑term treatment with azetukalner for the treatment of MDD.
2. To assess the efficacy of long-term treatment with azetukalner for the treatment of anhedonia.
3. To assess the clinician-perceived efficacy of long-term treatment with azetukalner for the treatment of MDD.
4. To assess the impact of azetukalner on quality of life.

Conditions and MedDRA coding

Major Depressive Disorder

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Participant successfully completed the treatment period of an antecedent Phase 3 study evaluating azetukalner in participants with MDD.
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. Participant is willing to comply with the contraception requirements
4. Male participants must agree not to donate sperm until 3 months after the last dose of study drug. Female participants must agree not to donate ova until 3 months after the last dose of study drug.

Exclusion criteria 7

1. Participant met any of the withdrawal criteria, or discontinued study drug early, or was terminated early from an antecedent study.
2. Participant had any protocol deviations in an antecedent azetukalner study that, in the opinion of the investigator, would preclude participation in this study.
3. Participant is unable to comply with study procedures or is inappropriate for the study, as judged by the investigator.
4. 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.
5. Participant is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for treatment of any medical condition during the study or within 28 days after completion of this study.
6. Participant is judged to have a significant risk for self-harm or suicidal behavior or is considered to be an imminent danger to themself or others, as determined by the C-SSRS or in the opinion of the investigator.
7. Female participant who is pregnant, breastfeeding, or planning to become pregnant within 3 months after the last dose of study drug

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 4

1. Change from baseline in the HAMD-17 total score over time.
2. Change from baseline in the SHAPS total score over time.
3. Change in the CGI-S score over time.
4. Change from baseline in Q-LES-Q-SF total score, Q-LES-Q-SF medication and life satisfaction and contentment in item scores, and SDS total score and subscale scores 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

Xenon Medical Affairs

Public contact point

Organisation

Xenon Pharmaceuticals Inc.

Contact name

Xenon Medical Affairs

Third parties 14

Locations

6 EU/EEA countries · 18 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Documents 70 files

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

Application history

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