Not yet recruiting

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

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Start of medication
The administration of the test medication, azetukalner, begins. this is provided in a 20 mg capsule form.
The capsule is taken orally (by mouth) once every day.
Step 2
Monitoring of safety and effects
The safety and how well the body tolerates the medication are monitored throughout the long-term treatment period.
Changes in depressive symptoms, which are measured using specific clinical scales, are tracked over time to assess the effectiveness of the azetukalner.

Who can join the trial?

5 criteria

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 trial?

7 criteria

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.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

CHU Grenoble Alpes
Verified
La Tronche, France
Centre Hospitalier Universitaire De Nimes
Verified
Nimes, France
Goethe University Frankfurt
Verified
Frankfurt, Germany

Trial locations

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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.

Azetukalner

What is already known about the treatment

Azetukalner - This medication is taken by mouth in the form of a capsule once per day. Currently being studied in clinical trials, it is being investigated as a potential treatment for depressive episodes in people living with bipolar disorder. This drug works by influencing specific chemical messengers in the brain to help balance mood and stabilize emotions. It is classified as an antiepileptic medication, a category of drugs often used to manage various brain-related conditions.

Investigated diseases

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.