A study to evaluate the safety and effectiveness of azetukalner in patients with bipolar depression

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What is this study about?

This study focuses on individuals experiencing Bipolar Depression, which refers to periods of intense sadness or low mood that occur as part of Bipolar Disorder. This condition is characterized by shifts in mood, energy, and activity levels. The research aims to assess the safety and how well a person can tolerate a long-term treatment using the medication azetukalner, which is provided in the form of a 20 mg oral capsule.

During the study, participants will take one dose of XPF-010 every day. The process involves monitoring how the body reacts to the medication over an extended period to ensure it is safe for continued use. The study is open-label, meaning that both the researchers and the participants will know which medication is being administered.

Who Can Join the Study?

You have previously finished the treatment part of an earlier Phase 3 study, which is a large-scale clinical test used to check if a medicine is safe and works well.
You have bipolar depression, which is a type of mood disorder where a person experiences periods of very low mood (depression) along with periods of abnormally high energy or mood.
You are able to give written informed consent, meaning you have read the study information, understand what will happen, and have signed a document to show you agree to join.
You are able to understand all the steps of the study and the rules you must follow.
You agree to use contraception, which refers to methods used to prevent pregnancy, as instructed by the study rules.

Who Cannot Join the Study?

People who have previously stopped taking a study drug early, were removed from a previous study, or met the rules for leaving a past study.
People who did not follow the rules of a previous study in a way that the researcher believes makes it unsafe or difficult for them to join this study.
People with any health problem, personal situation, or an adverse event (an unexpected or harmful medical occurrence) from a previous study that the researcher believes creates too much risk or makes it impossible to follow the study rules.
Women who are pregnant, breastfeeding, or who are planning to become pregnant.
People who plan to join another study using a different investigational drug (a medicine being tested for the first time) or plan to use an experimental medical device during the study or within 28 days after the study ends.
People who the researcher believes are at a high risk of self-harm (hurting themselves) or suicidal behavior (thoughts or actions of ending one’s life), or those who are considered a danger to themselves or others.
People who have had an active plan or intention to end their life, as determined by specific screening questions or the researcher’s medical assessment.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Hospital Universitario De Salamanca	Salamanca	Spain
Hospital Clinico San Carlos	Madrid	Spain
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Medical Center Hera EOOD	Sofia	Bulgaria
Centre Hospitalier Universitaire De Nimes	Nimes	France
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Diagnostics-Consultancy Center Mladost M Varna OOD	Varna	Bulgaria
Medical Center Saint Naum EOOD	Sofia	Bulgaria
Hospital Alvaro Cunqueiro	Vigo	Spain
Servei De Salut De Les Illes Balears	Palma	Spain
Multi-profile Hospital for Active Treatment Heart and Brain EAD	Pleven	Bulgaria
Diagnostichno-Konsultativen Centar XI-Sofia ЕООД	Sofia	Bulgaria
Multiprofile Hospital For Active Treatment Dr. Hristo Stambolski EOOD	Kazanlak	Bulgaria
Instituto De Investigaciones Neuropsiquiatricas Doctor Lopez Ibor S.A.	Madrid	Spain
Dxvlnofdj Rzerlyudd	Douai	France
Cdmukh Fnm Msyajj Hxnbah Vkepzw Evzu	Vratsa	Bulgaria
Utsgvznisjyasqxfdpwsw Mcrqsggr Aje	Munster	Germany
Gcxtuj Uxcxmtblmj Fmaridjeu	Frankfurt	Germany
Sdudc Pmjyvsedpyq Hkcnwayz &nmihkm Lyjcxo	Lovech	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Not yet recruiting	30.06.2026
France	Not recruiting	30.06.2026
Germany	Not yet recruiting	30.06.2026
Spain	Not yet recruiting	30.06.2026

Trial locations

Investigated drugs:

Azetukalner

Azetukalner is an oral medication being studied to see how safe and effective it is for people experiencing depressive episodes associated with bipolar disorder.

Bipolar depression – This condition involves periods of intense sadness and low energy that occur as part of bipolar disorder. It is characterized by mood swings that shift between emotional highs and lows. During these episodes, an individual may experience a loss of interest in activities and a lack of motivation. The condition fluctuates in severity and can occur in both bipolar I and bipolar II types. Over time, these depressive phases may repeat or vary in duration.

Trial ID:

2025-522872-10-00

Protocol code:

XPF-010-B302

NCT ID:

NCT07217860

Trial Phase:

Therapeutic confirmatory (Phase III)

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A study to evaluate the safety and effectiveness of azetukalner in patients with bipolar depression

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?