An Open-Label Study of Azetukalner in Major Depressive Disorder
Public ClinicalTrials.gov record NCT06922110. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of Azetukalner in Major Depressive Disorder
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT06922110
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 460 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 18, 2025 (Actual)
- Primary completion
- Jan 2027 (Estimated)
- Completion
- Mar 2027 (Estimated)
- Last update posted
- Oct 13, 2026
2025 – 2027
United States locations
- U.S. sites
- 69
- U.S. states
- 21
- U.S. cities
- 61
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ima Clinical Research - Phoenix | Phoenix | Arizona | 85012 | — |
| Sanro Clinical Research Group, Llc | Bryant | Arkansas | 72022 | — |
| Woodland International Research Group | Little Rock | Arkansas | 72211 | — |
| Woodland Research Northwest | Rogers | Arkansas | 72758 | — |
| Cenexel Cit - Bellflower | Bellflower | California | 90706 | — |
| Irvine Clinical Research | Irvine | California | 92614 | — |
| Calneuro Research Group, Inc. | Los Angeles | California | 90025 | — |
| Excell Research Inc. | Oceanside | California | 92056 | — |
| Atp Clinical Research | Orange | California | 92866 | — |
| Nrc Research Institute | Orange | California | 92868 | — |
| Artemis Institute For Clinical Research - San Diego | San Diego | California | 92123 | — |
| Cenexel Cnr - Sherman Oaks | Sherman Oaks | California | 91403-2131 | — |
| Cenexel Cns - Torrance | Torrance | California | 90501 | — |
| Pacific Clinical Research Management | Upland | California | 91786 | — |
| Sunwise Clinical Research | Walnut Creek | California | 94596 | — |
| Ct Clinical Research Associates | Cromwell | Connecticut | 06416 | — |
| Institute of Living - Clinical Trials Unit | Hartford | Connecticut | 06106 | — |
| Pharmasouth Research | Coral Gables | Florida | 33146 | — |
| Cns Clinical Research - Coral Springs | Coral Springs | Florida | 33067 | — |
| Gulfcoast Clinical Research Center | Fort Myers | Florida | 33912 | — |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | — |
| Neoclinical Research | Hialeah | Florida | 33016 | — |
| Clinical Neuroscience Solutions Llc. | Jacksonville | Florida | 32256 | — |
| Accel Research Sites - Lakeland | Lakeland | Florida | 33803 | — |
| Accel Research Sites - St. Petersburg-Largo | Largo | Florida | 33777 | — |
| Harmony Clinical Research Inc | North Miami Beach | Florida | 33162 | — |
| Clinical Neuroscience Solutions Llc | Orlando | Florida | 32801 | — |
| Combined Research Orlando Phase I-Iv | Orlando | Florida | 32807 | — |
| Panhandle Research and Medical Clinic | Pensacola | Florida | 32502 | — |
| Equipath Health and Research Tampa Bay, Llc | Riverview | Florida | 33578 | — |
| Advanced Discovery Research, Llc | Atlanta | Georgia | 30318 | — |
| Synexus - Atlanta | Atlanta | Georgia | 30328 | — |
| DelRicht Research | Atlanta | Georgia | 30329 | — |
| Cenexel Iresearch - Atlanta | Decatur | Georgia | 30030 | — |
| Psych Atlanta, Pc | Marietta | Georgia | 30060 | — |
| Cenexel Iresearch - Savannah | Savannah | Georgia | 31405 | — |
| IMA Clinical Research | Chicago | Illinois | 60634 | — |
| Advanced Quality Medical Research, LLC | Orland Park | Illinois | 60462 | — |
| Pharmasite Research Inc. | Baltimore | Maryland | 21208-6605 | — |
| Adams Clinical - Boston | Boston | Massachusetts | 02116 | — |
| Boston Clinical Trials Llc | Boston | Massachusetts | 02131 | — |
| Elixia MA, LLC | Springfield | Massachusetts | 01103 | — |
| Adams Clinical - Watertown | Watertown | Massachusetts | 02472 | — |
| Vitalix Clinical - Worcester | Worcester | Massachusetts | 01608 | — |
| Psychiatric Care and Research Center | O'Fallon | Missouri | 63368 | — |
| St. Charles Psychiatric Associates - Midwest Research Group | Saint Charles | Missouri | 63304 | — |
| Ima Clinical Research - Las Vegas | Las Vegas | Nevada | 89102 | — |
| Redbird Research | Las Vegas | Nevada | 89119 | — |
| Center For Emotional Fitness | Cherry Hill | New Jersey | 08002 | — |
| Global Medical Institutes - Princeton Medical Institute | Princeton | New Jersey | 08540 | — |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | — |
| Integrative Clinical Trials, Llc | Brooklyn | New York | 11229 | — |
| Bioscience Research Llc. | Mount Kisco | New York | 10549 | — |
| Fieve Clinical Research (Fcr), Inc. | New York | New York | 10017-1921 | — |
| Ima Clinical Research - Nyc Uptown | New York | New York | 10128 | — |
| Richmond Behavioral Associates | Staten Island | New York | 10314 | — |
| Magnolia Clinical Research | Cary | North Carolina | 27511 | — |
| New Hope Clinical Research | Charlotte | North Carolina | 28211 | — |
| Insight Clinical Trials Llc | Independence | Ohio | 44131 | — |
| Pahl Pharmaceutical Professionals Llc | Oklahoma City | Oklahoma | 73112 | — |
| Sooner Clinical Research | Oklahoma City | Oklahoma | 73116 | — |
| Lehigh Center For Clinical Research | Allentown | Pennsylvania | 18103 | — |
| Adams Clinical Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Clinical Neuroscience Solutions, LLC | Memphis | Tennessee | 38119 | — |
| Austin Clinical Trial Partners | Austin | Texas | 78737 | — |
| Delricht Research - Plano | Plano | Texas | 75024 | — |
| Grayline Research Center | Wichita Falls | Texas | 76309 | — |
| Boeson Research Pvu | Provo | Utah | 84604 | — |
| Core Clinical Research | Everett | Washington | 98201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06922110, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 13, 2026 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06922110 live on ClinicalTrials.gov.