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An Open-label Study of Azetukalner in Bipolar I or II Depression
EU CTIS ID: 2025-522872-10-00
What this study is testing
To assess the safety and tolerability of long-term treatment with 20 mg azetukalner once daily in participants with bipolar depression.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Participant successfully completed the treatment period in a Phase 3 antecedent study evaluating azetukalner in participants with bipolar depression
- 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.
- 3. Participant is willing to comply with the protocol contraception requirements, as defined in the protocol.
You likely can't join if
- 1. Participant met any of the withdrawal criteria, discontinued study drug early, or was terminated early from an antecedent study.
- 2. Participant had any protocol deviations in an antecedent study that, in the opinion of the investigator, would preclude participation in this study.
- 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.
- 4. Female participant who is pregnant, breastfeeding, or planning to become pregnant.
- 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.
- 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.
See the full eligibility criteria
- 1. Participant successfully completed the treatment period in a Phase 3 antecedent study evaluating azetukalner in participants with bipolar depression
- 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.
- 3. Participant is willing to comply with the protocol contraception requirements, as defined in the protocol.
- 1. Participant met any of the withdrawal criteria, discontinued study drug early, or was terminated early from an antecedent study.
- 2. Participant had any protocol deviations in an antecedent study that, in the opinion of the investigator, would preclude participation in this study.
- 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.
- 4. Female participant who is pregnant, breastfeeding, or planning to become pregnant.
- 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.
- 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.
- 7. Participant 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.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Serbia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Serbia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.