Bipolar DepressionPhase 3NCT07217860
An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)
A Phase 3 study testing Azetukalner in people with Bipolar Depression and Bipolar I Disorder, run by Xenon Pharmaceuticals Inc. at 20 sites in United States.
Trial summary
X-CEED-OLE is a Phase 3, multicenter, open-label study to evaluate the long-term safety, tolerability, and efficacy of azetukalner in adult participants who successfully completed an antecendent Phase 3 azetukalner bipolar depression study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bipolar Depression, Bipolar I Disorder, Bipolar Disorder
- What is being tested?
- Azetukalner
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 20 sitesUnited States
- Study dates
- 30 Oct 2025to Aug 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant successfully completed the treatment period in a Phase 3 antecedent study evaluating azetukalner in participants with bipolar depression.
- 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.
- Participant is willing to comply with the contraception requirements.
Who cannot join
- Participant met any of the withdrawal criteria, discontinued study drug early, or was terminated early from an antecedent study.
- Participant had any protocol deviations in an antecedent study that, in the opinion of the investigator, would preclude participation in this study.
- 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.
- Participant is pregnant, breastfeeding, or planning to become pregnant.
- 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.
- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18103
Synexus Clinical Research, Inc.
Atlanta, Georgia, 30328
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Clinical Innovations, Inc, dba CITrials
Bellflower, California, 90706
Neurobehavioral Research Inc
Cedarhurst, New York, 11516
Lumina Clinical Research Center
Cherry Hill, New Jersey, 92866
PharmaSouth Research, LLC
Coral Gables, Florida, 33146
ProScience Research Group
Culver City, California, 90230
CenExel iResearch
Decatur, Georgia, 30030
Core Clinical Research
Everett, Washington, 98201
Clinical Neuroscience Solutions, LLC
Jacksonville, Florida, 32256
Woodland International Research Group
Little Rock, Arkansas, 72211
Clinical Neuroscience Solutions, LLC
Memphis, Tennessee, 38119
Central Miami Medical Institute
Miami, Florida, 33125
Advanced Quality Medical Research
Orland Park, Illinois, 60462
Clinical Neuroscience Solutions, LLC
Orlando, Florida, 32801
Clinical Innovations, Inc
Riverside, California, 92506
Woodland Research Northwest
Rogers, Arkansas, 72758
Denali Health Atlanta, LLC
Stone Mountain, Georgia, 30083
Grayline Research Center
Wichita Falls, Texas, 76309
About this study
Official title: A Multicenter, Long-term, Open-Label, Safety, Tolerability, and Efficacy Study of Azetukalner in Bipolar I or II Depression
X-CEED-OLE is a Phase 3, multicenter, open-label study to evaluate the long-term safety, tolerability, and efficacy of azetukalner in adult participants who successfully completed an antecendent Phase 3 azetukalner bipolar depression study.
- Being tested
- Azetukalner
- Keywords
- Bipolar, XEN1101, Azetukalner
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzetukalnerDrug
Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Azetukalner 20 mg | Experimental | Not described Receives: Drug: Azetukalner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity and frequency of treatment-emergent adverse events, serious adverse events, adverse events of special interest, and events of clinical interest
Measured: From the start of treatment in the open-label extension study through 8 weeks after the last dose
Secondary outcomes (3)
Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score over time
Measured: From baseline through the active extension treatment (Week 52)
Change in Clinical Global Impression of Severity (CGI-S) score over time
Measured: From baseline through the active extension treatment (Week 52)
Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score over time
Measured: From baseline through the active extension treatment (Week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start30 Oct 2025
- Primary completionJun 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xenon Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217860
- Sponsor's protocol ID
- XPF-010-B302
- Status last verified
- Jun 2026
- First submitted
- 14 Oct 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Long-term, Open-Label, Safety, Tolerability, and Efficacy Study of Azetukalner in Bipolar I or II Depression
- ClinicalTrials.gov ID
- NCT07217860
- Acronym / sponsor ID
- XPF-010-B302
- Keywords
- Bipolar, XEN1101, Azetukalner
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Xenon Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 20 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
X-CEED-OLE is a Phase 3, multicenter, open-label study to evaluate the long-term safety, tolerability, and efficacy of azetukalner in adult participants who successfully completed an antecendent Phase 3 azetukalner bipolar depression study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Azetukalner 20 mg | Experimental | Drug: Azetukalner |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant successfully completed the treatment period in a Phase 3 antecedent study evaluating azetukalner in participants with bipolar depression.
- 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.
- Participant is willing to comply with the contraception requirements.
Key exclusion criteria (6 listed)
- Participant met any of the withdrawal criteria, discontinued study drug early, or was terminated early from an antecedent study.
- Participant had any protocol deviations in an antecedent study that, in the opinion of the investigator, would preclude participation in this study.
- 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.
- Participant is pregnant, breastfeeding, or planning to become pregnant.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzetukalnerAzetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 52 weeks. | Drug | Azetukalner 20 mg |
Primary outcome
Severity and frequency of treatment-emergent adverse events, serious adverse events, adverse events of special interest, and events of clinical interest
Time frame: From the start of treatment in the open-label extension study through 8 weeks after the last dose
3 secondary outcomes
Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score over time
Time frame: From baseline through the active extension treatment (Week 52)
Change in Clinical Global Impression of Severity (CGI-S) score over time
Time frame: From baseline through the active extension treatment (Week 52)
Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score over time
Time frame: From baseline through the active extension treatment (Week 52)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression) (X-CEED)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azetukalner in people with Bipolar Depression and Bipolar I Disorder, run by Xenon Pharmaceuticals Inc. at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity and frequency of treatment-emergent adverse events, serious adverse events, adverse events of special interest, and events of clinical interest (time frame: From the start of treatment in the open-label extension study through 8 weeks after the last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.