A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures
Public ClinicalTrials.gov record NCT05614063. 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 Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The X-TOLE2 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.
Study identification
- NCT ID
- NCT05614063
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 380 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
- Nov 18, 2022 (Actual)
- Primary completion
- Jan 12, 2026 (Actual)
- Completion
- Feb 3, 2026 (Actual)
- Last update posted
- May 14, 2026
2022 – 2026
United States locations
- U.S. sites
- 56
- U.S. states
- 28
- U.S. cities
- 50
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Strada Patient Care Center | Mobile | Alabama | 36604 | — |
| Xenoscience | Phoenix | Arizona | 85004 | — |
| University of Arizona, Health Sciences Center | Tucson | Arizona | 85724 | — |
| Clinical Trials, Inc | Little Rock | Arkansas | 72205 | — |
| Brain Science Research Institute | Los Angeles | California | 90025 | — |
| University of California, David Clinical & Translational Science Center Clinical Research (CCRC) | Sacramento | California | 95817 | — |
| Anschutz Health Sciences | Aurora | Colorado | 80011 | — |
| Serenity Research | Miami | Florida | 33176 | — |
| Research Institute of Orlando, LLC | Orlando | Florida | 32806 | — |
| Panhandle Research & Medical Clinic | Pensacola | Florida | 32503 | — |
| Medsol Clinical Research Center | Port Charlotte | Florida | 33952 | — |
| University of South Florida | Tampa | Florida | 33606 | — |
| Encore Medical Research of Weston, LLC | Weston | Florida | 33021 | — |
| Emory Brain Health Center | Atlanta | Georgia | 30329 | — |
| Hawaii Pacific Neuroscience | Honolulu | Hawaii | 96817 | — |
| Consultants in Epilepsy and Neurology | Boise | Idaho | 83702 | — |
| Indiana University, IU Health Partners, Adult Neurology Clinic | Indianapolis | Indiana | 46202 | — |
| The University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Bluegrass Epilepsy Research, LLC | Lexington | Kentucky | 40504 | — |
| University of Kentucky, Dept. of Neurology | Lexington | Kentucky | 40536-0284 | — |
| MaineHealth Neurology - Scarborough | Scarborough | Maine | 04074 | — |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | — |
| Medstar Franklin Square Medical Center | Baltimore | Maryland | 21237 | — |
| Mid-Atlantic Epilepsy and Sleep Center | Bethesda | Maryland | 20817 | — |
| MedStar Georgetown University Hospital | Clinton | Maryland | 20735 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Michigan State University | East Lansing | Michigan | 48824 | — |
| Cornwell Health | Grand Rapids | Michigan | 49506 | — |
| Minneapolis Clinic of Neurology | Burnsville | Minnesota | 55337 | — |
| Saint Louis University Medical School - Neurosciences Clinical Research Unit | St Louis | Missouri | 63104 | — |
| Washington University, St. Louis | St Louis | Missouri | 63110 | — |
| Northeast Epilepsy Group | Hackensack | New Jersey | 07601 | — |
| Dent Neurosciences Research Center | Buffalo | New York | 14226 | — |
| NYU Comprehensive Epilepsy Center (CEC) | New York | New York | 10016 | — |
| Weill Cornell Medicine/ New York-Presbyterian Hospital | New York | New York | 10021 | — |
| Mount Sinai Medical Center | New York | New York | 10029 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| Montefiore Medical Center | The Bronx | New York | 10467-2401 | — |
| Onsite Clinical Solutions, LLC | Charlotte | North Carolina | 28211 | — |
| Duke Neurology | Durham | North Carolina | 27713 | — |
| Meridian Clinical Research, LLC | Raleigh | North Carolina | 27607 | — |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | — |
| Summa Health | Akron | Ohio | 44304 | — |
| Providence Brain & Spine Institute | Portland | Oregon | 97225 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140-4105 | — |
| Austin Epilepsy Care Center (AECC) | Austin | Texas | 78758 | — |
| ANESC Research | El Paso | Texas | 79912 | — |
| UT Physicians Epilepsy Clinic | Houston | Texas | 77030 | — |
| UT Health San Antonio | San Antonio | Texas | 78229 | — |
| Carilion Clinic - Neurology | Roanoke | Virginia | 24013 | — |
| Sentara Neurology Specialists | Virginia Beach | Virginia | 23456 | — |
| University of Washington Main Hospital | Seattle | Washington | 98104 | — |
| Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | — |
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 69 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05614063, 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 May 14, 2026 · Synced Oct 31, 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 NCT05614063 live on ClinicalTrials.gov.