Clinical trial for Major Depressive Disorder
Official title An Open-Label Study of Azetukalner in Major Depressive Disorder
ClinicalTrials.gov ID: NCT06922110
What this study is testing
What is Azetukalner?
Azetukalner is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for major depressive disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- X-NOVA-OLE is a multicenter, open-label study to evaluate the long-term safety, tolerability, and efficacy of azetukalner as a monotherapy in adult participants who successfully completed an antecedent Phase 3 study of azetukalner in Major Depressive Disorder (MDD).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant successfully completed the treatment period of an antecedent azetukalner Phase 3 study in MDD.
- Participant provides written informed consent to participate in the study, is able to understand the procedures and study requirements, and agrees to...
- Participant is willing to comply with the contraception requirements.
- Male participants must agree not to donate sperm until 3 months after the last dose of study drug. Female participants must agree not to donate ova...
You likely can't join if
- Participant met any of the withdrawal criteria, or discontinued study drug early, or was terminated early from an antecedent study.
- Participant had any protocol deviations in an antecedent azetukalner study that, in the opinion of the investigator, would preclude participation in...
- Participant is unable to comply with study procedures or is inappropriate for the study, as judged by the investigator.
- Participant has any medical condition, personal circumstance, or ongoing AE (from an antecedent study) that, in the opinion of the investigator...
- Female participant who is pregnant, breastfeeding, or planning to become pregnant within 3 months after the last dose of study drug.
- Participant is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for treatment of...
See the full eligibility criteria
- Participant successfully completed the treatment period of an antecedent azetukalner Phase 3 study in MDD.
- 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.
- Participant is willing to comply with the contraception requirements.
- Male participants must agree not to donate sperm until 3 months after the last dose of study drug. Female participants must agree not to donate ova until 3 months after the last dose of study drug.
- Participant met any of the withdrawal criteria, or discontinued study drug early, or was terminated early from an antecedent study.
- Participant had any protocol deviations in an antecedent azetukalner study that, in the opinion of the investigator, would preclude participation in this study.
- Participant is unable to comply with study procedures or is inappropriate for the study, as judged by the investigator.
- 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...
- Female participant who is pregnant, breastfeeding, or planning to become pregnant within 3 months after the last dose of study drug.
- Participant is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for treatment of any medical condition during the study or within 28 days after...
- Participant is judged to have a significant risk for self-harm or suicidal behavior or is considered to be an imminent danger to themself or others, as determined by the C-SSRS or in the opinion of the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Bryant, Arkansas, United States
- Little Rock, Arkansas, United States
- Rogers, Arkansas, United States
- Bellflower, California, United States
- Los Angeles, California, United States
- Oceanside, California, United States
- Orange, California, United States
- San Diego, California, United States
- Sherman Oaks, California, United States
- Torrance, California, United States
- Upland, California, United States
- Walnut Creek, California, United States
- Cromwell, Connecticut, United States
- Hartford, Connecticut, United States
- Coral Gables, Florida, United States
- Coral Springs, Florida, United States
- Fort Myers, Florida, United States
- Gainesville, Florida, United States
- Hialeah, Florida, United States
+ 40 more site(s).
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Bryant, Arkansas, United States; Little Rock, Arkansas, United States; Rogers, Arkansas, United States; Bellflower, California, United States; Los Angeles, California, United States and 54 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.