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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 Status
Hospital Universitario De Salamanca Salamanca Spain
Technische Universitaet Dresden Dresden Germany
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Moxdspa Cguehf Hdhr Ejvj Sofia Bulgaria
Hrwnttfp Cxmokzi Saz Cqqveq Madrid Spain
Uokchogegbegcgvemllzn Mzxqmgze Arm Munster Germany
Ckrjbl Hcdnimayfjo Ugrjvfntdhqcq De Nypfa Nimes France
Sronpi Dt Shdpq Dn Lvu Infki Bvndfhh Palma Spain
Mzuqqnw Cqqtsu Souaa Nbyg Eehm Sofia Bulgaria
Djuysfzlp Rnumjuzpn Douai France
Mgxedkgldugy Hqdoobbr Fhi Aiobpw Tyxhmlofg Dbk Hjdstj Svbzbhjiqq Eefh Kazanlak Bulgaria
Idpfmnzqu Dj Istfpdywmbkdkxv Nlrhfojivruqjrsray Denhmy Lgiyp Ixxa Smzz Madrid Spain
Gykfob Uyvoyqeswm Fxykesxiy Frankfurt Germany
Hxbkscfx Aeydgt Cesqlzqvc Vigo Spain
Corxav Fsm Mthlbu Hlvwvl Viivhy Edkr Vratsa Bulgaria
Dlyexsuevuphuyzevllvsyr Cjirgy Msjtemx M Vxsve Oko Varna Bulgaria
Mvhpvvwhaxhci Hsewcnpk fpo Addost Ttttwogol Hzsdk abh Bytdt Efw Pleven Bulgaria
Sommw Ptmnrbtfhni Hmgufben &xfzcft Lqmflc Lovech Bulgaria
Dwxfunwpcnjwltqyltdkhrwichp Cpwpzj Xrwlpbty Еzpn Sofia Bulgaria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

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

Trial locations

Investigated Drugs:

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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