Clinical trial • Phase III • Psychiatry
AZETUKALNER for Bipolar depression
Phase III trial of AZETUKALNER for Bipolar depression. open-label, none/not specified-controlled. 320 participants.
Overview
- Trial Therapeutic Area
- Psychiatry
- Trial Disease
- Bipolar depression
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 16-12-2025
- First CTIS Authorization Date
- 28-04-2026
Trial design
open-label, none/not specified-controlled Phase III trial across 22 sites in Bulgaria, France, Germany and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 320
- Trial Duration For Participant
- 420
Eligibility
Recruits 320 Vulnerable population selected. Inclusion requires written informed consent: "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." Subject information and informed consent forms are provided (multiple language versions listed in trial documents). No specific assent or minor-consent procedures are described in the available data..
- Pregnancy Exclusion
- 4. Female participant who is pregnant, breastfeeding, or planning to become pregnant.
- Vulnerable Population
- Vulnerable population selected. Inclusion requires written informed consent: "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." Subject information and informed consent forms are provided (multiple language versions listed in trial documents). No specific assent or minor-consent procedures are described in the available data.
Inclusion criteria
- {"criterion_text":"- 1. Participant successfully completed the treatment period in a Phase 3 antecedent study evaluating azetukalner in participants with bipolar depression\n- 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.\n- 3. Participant is willing to comply with the protocol contraception requirements, as defined in the protocol."}
Exclusion criteria
- {"criterion_text":"- 1. Participant met any of the withdrawal criteria, discontinued study drug early, or was terminated early from an antecedent study.\n- 2. Participant had any protocol deviations in an antecedent study that, in the opinion of the investigator, would preclude participation in this study.\n- 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.\n- 4. Female participant who is pregnant, breastfeeding, or planning to become pregnant.\n- 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.\n- 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.\n- 7.\tParticipant 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 endpoints
- {"endpoint_text":"- Severity and frequency of TEAEs, SAEs, AESIs and ECIs","definition_or_measurement_approach":"Severity and frequency of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs) and events of clinical interest (ECIs) as reported and recorded during the study."}
Secondary endpoints
- {"endpoint_text":"- Change from baseline in the MADRS total score over time.","definition_or_measurement_approach":"Change from baseline measured using the MADRS (Montgomery–Åsberg Depression Rating Scale) total score over time."}
- {"endpoint_text":"- Change in CGI-S score over time.","definition_or_measurement_approach":"Change over time measured using the Clinical Global Impression - Severity (CGI-S) score."}
- {"endpoint_text":"- Change from baseline in the SHAPS total score over time.","definition_or_measurement_approach":"Change from baseline measured using the SHAPS (Snaith-Hamilton Pleasure Scale) total score over time."}
Recruitment
- Planned Sample Size
- 320
- Recruitment Window Months
- 37
- Consent Approach
- Participants must provide written informed consent: "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." Subject information and informed consent forms are provided and listed in the trial documents in multiple languages (examples include English, Bulgarian, German, French, Spanish, Polish). There is a specific ICF for a pregnant partner listed. No assent or minor-consent procedures are described.
Geography
- Total Number Of Sites
- 22
- Total Number Of Participants
- 70
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 14-04-2026
- Latest Decision Or Authorization Date
- 04-05-2026
- Processing Time Days
- 20
- Number Of Sites
- 9
- Number Of Participants
- 30
Sites
- Site Name
- Center For Mental Health Vratsa EOOD
- Department Name
- Psychiatry
- Principal Investigator Name
- Nadya Emilova Ivanova
- Principal Investigator Email
- nadia_odpzs@abv.bg
- Contact Person Name
- Nadya Emilova Ivanova
- Contact Person Email
- nadia_odpzs@abv.bg
- Site Name
- Diagnostics-Consultancy Center Mladost M Varna OOD
- Department Name
- Psychiatry
- Principal Investigator Name
- Hristo Vasilev Kozhuharov
- Principal Investigator Email
- christokojuharov@abv.bg
- Contact Person Name
- Hristo Vasilev Kozhuharov
- Contact Person Email
- christokojuharov@abv.bg
- Site Name
- State Psychiatric Hospital Lovech
- Department Name
- Psychiatry
- Principal Investigator Name
- Lyudmil Zdravkov Tumbev
- Principal Investigator Email
- tumbev.dpb.lovech@abv.bg
- Contact Person Name
- Lyudmil Zdravkov Tumbev
- Contact Person Email
- tumbev.dpb.lovech@abv.bg
- Site Name
- University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
- Department Name
- Psychiatry
- Principal Investigator Name
- Maya Yordanova Stoimenova-Popova
- Principal Investigator Email
- dr.maya.stoimenova@gmail.com
- Contact Person Name
- Maya Yordanova Stoimenova-Popova
- Contact Person Email
- dr.maya.stoimenova@gmail.com
- Site Name
- Diagnostichno-Konsultativen Centar XI-Sofia ЕООД
- Department Name
- Psychiatry
- Principal Investigator Name
- Tina Ivanova Blajeva
- Principal Investigator Email
- tina_blajeva@yahoo.com
- Contact Person Name
- Tina Ivanova Blajeva
- Contact Person Email
- tina_blajeva@yahoo.com
- Site Name
- Multiprofile Hospital For Active Treatment Dr. Hristo Stambolski EOOD
- Department Name
- Psychiatry
- Principal Investigator Name
- Ivan Todorov Dimitrov
- Principal Investigator Email
- itdim@abv.bg
- Contact Person Name
- Ivan Todorov Dimitrov
- Contact Person Email
- itdim@abv.bg
- Site Name
- Diagnostics-Consultancy Center Mladost M Varna OOD
- Department Name
- Psychiatry
- Principal Investigator Name
- Petar Petrov
- Principal Investigator Email
- pmdown@abv.bg
- Contact Person Name
- Petar Petrov
- Contact Person Email
- pmdown@abv.bg
- Site Name
- Medical Center Saint Naum EOOD
- Department Name
- Psychiatry
- Principal Investigator Name
- Assen Jivkov Karadaliev
- Principal Investigator Email
- karadaliev@hotmail.com
- Contact Person Name
- Assen Jivkov Karadaliev
- Contact Person Email
- karadaliev@hotmail.com
- Site Name
- Medical Center Hera EOOD
- Department Name
- Psychiatry
- Principal Investigator Name
- Spiridon Aleksiev Spiridonov
- Principal Investigator Email
- spiridon.aleksiev@gmail.com
- Contact Person Name
- Spiridon Aleksiev Spiridonov
- Contact Person Email
- spiridon.aleksiev@gmail.com
France
- Earliest CTIS Part Ii Submission Date
- 16-03-2026
- Latest Decision Or Authorization Date
- 28-04-2026
- Processing Time Days
- 43
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Psychiatry
- Principal Investigator Name
- Mircea Polosan
- Principal Investigator Email
- mpolosan@chu-grenoble.fr
- Contact Person Name
- Mircea Polosan
- Contact Person Email
- mpolosan@chu-grenoble.fr
- Site Name
- Desbonnet Recherche
- Department Name
- Psychiatry
- Principal Investigator Name
- Desbonnet Philippe
- Principal Investigator Email
- philippe.desbonnet654@orange.fr
- Contact Person Name
- Desbonnet Philippe
- Contact Person Email
- philippe.desbonnet654@orange.fr
- Site Name
- Centre Hospitalier Universitaire De Nimes
- Department Name
- Psychiatry
- Principal Investigator Name
- Fabrice Boulet
- Principal Investigator Email
- fabrice.boulet@chu-nimes.fr
- Contact Person Name
- Fabrice Boulet
- Contact Person Email
- fabrice.boulet@chu-nimes.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 17-04-2026
- Latest Decision Or Authorization Date
- 29-04-2026
- Processing Time Days
- 12
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Technische Universitaet Dresden
- Department Name
- Psychiatry
- Principal Investigator Name
- Philipp Ritter
- Principal Investigator Email
- philipp.ritter@uniklinikum-dresden.de
- Contact Person Name
- Philipp Ritter
- Contact Person Email
- philipp.ritter@uniklinikum-dresden.de
- Site Name
- Universitaetsklinikum Muenster AöR
- Department Name
- Psychiatry
- Principal Investigator Name
- Bernhard Theodor Baune
- Principal Investigator Email
- bernhard.baune@ukmuenster.de
- Contact Person Name
- Bernhard Theodor Baune
- Contact Person Email
- bernhard.baune@ukmuenster.de
- Site Name
- Goethe University Frankfurt
- Department Name
- Psychiatry
- Principal Investigator Name
- Andreas Reif
- Principal Investigator Email
- andreas.reif@med.uni-frankfurt.de
- Contact Person Name
- Andreas Reif
- Contact Person Email
- andreas.reif@med.uni-frankfurt.de
Spain
- Earliest CTIS Part Ii Submission Date
- 13-02-2026
- Latest Decision Or Authorization Date
- 04-05-2026
- Processing Time Days
- 80
- Number Of Sites
- 7
- Number Of Participants
- 20
Sites
- Site Name
- Hospital Universitario Infanta Elena
- Department Name
- Psychiatry
- Principal Investigator Name
- Enrique Baca García
- Principal Investigator Email
- ebaca@fjd.es
- Contact Person Name
- Enrique Baca García
- Contact Person Email
- ebaca@fjd.es
- Site Name
- Instituto De Investigaciones Neuropsiquiatricas Doctor Lopez Ibor S.A.
- Department Name
- Psychiatry
- Principal Investigator Name
- Ignacio Basurte Villamor
- Principal Investigator Email
- i.basurte@lopezibor.com
- Contact Person Name
- Ignacio Basurte Villamor
- Contact Person Email
- i.basurte@lopezibor.com
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Psychiatry
- Principal Investigator Name
- Ángel Luis Montejo González
- Principal Investigator Email
- amontejo@usal.es
- Contact Person Name
- Ángel Luis Montejo González
- Contact Person Email
- amontejo@usal.es
- Site Name
- University Hospital Son Espases
- Department Name
- Psychiatry
- Principal Investigator Name
- Joan Salva Coll
- Principal Investigator Email
- joan.salva@ssib.es
- Contact Person Name
- Joan Salva Coll
- Contact Person Email
- joan.salva@ssib.es
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Psychiatry
- Principal Investigator Name
- Eva María Sánchez Morla
- Principal Investigator Email
- emsmorla@gmail.com
- Contact Person Name
- Eva María Sánchez Morla
- Contact Person Email
- emsmorla@gmail.com
- Site Name
- Hospital Alvaro Cunqueiro
- Department Name
- Psychiatry
- Principal Investigator Name
- José Antonio Campos Pérez
- Principal Investigator Email
- Jose.antonio.campos.perez@sergas.es
- Contact Person Name
- José Antonio Campos Pérez
- Contact Person Email
- Jose.antonio.campos.perez@sergas.es
- Site Name
- Additional site (Institutions listed under Spain trialSites)
- Department Name
- Psychiatry
Sponsor
Primary sponsor
- Full Name
- Xenon Pharmaceuticals Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Canada
Contract research organisations
- Name
- Merit CRO Inc.
- Responsibilities
- Ophthalmologic assessment
- Name
- IQVIA Limited
- Responsibilities
- 8
- Name
- Lotus Clinical Research LLC
- Responsibilities
- 13;5;6
- Name
- Pivotal S.L.
- Responsibilities
- 1;12;13;2;5
- Name
- Altasciences Compagnie Inc.
- Responsibilities
- 4
Third parties
- {"country":"United States","full_name":"Merit CRO Inc.","duties_or_roles":"Ophthalmologic assessment","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"PCI Pharma Services Germany GmbH","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patients’ reimbursement","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Taxi Travel Ticket S.L.","duties_or_roles":"Patients’ reimbursement","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Spain","full_name":"Ipsory S.L.","duties_or_roles":"Patients’ reimbursement","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"7","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Lotus Clinical Research LLC","duties_or_roles":"13;5;6","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Altasciences Compagnie Inc.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Pivotal S.L.","duties_or_roles":"1;12;13;2;5","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- XPF-010
- Active Substance
- AZETUKALNER
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- 1
- Starting Dose
- 20 mg
- Dose Levels
- 20 mg
- Frequency
- Once daily (QD)
- Maximum Dose
- 20 mg
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