Clinical Trials in Mexico / NCT05718817
Enrolling by invitation
Phase 3
An Open-label Study of XEN1101 in Epilepsy
NCT05718817 · tracked via the Priya Life Science Mexico tracker
Condition(s) studied
Focal EpilepsyTonic-Clonic Seizures
Study summary
This study will evaluate the long term safety, tolerability, pharmacokinetics (PK), and efficacy of XEN1101 in subjects with Focal Onset Seizures (FOS) or Primary Generalized Tonic-Clonic Seizures (PGTCS) for the treatment of seizures for up to 6 years.
Eligibility
Inclusion Criteria:
1. Subject must be properly informed of the nature and risks of the study and give informed consent in writing prior to entering the study (for adult subjects) and for adolescent subject's parent/legal guardian and subject gives informed consent or assent in writing prior to entering the study.
2. Subject must have successfully completed the double-blind treatment period (DBP) and have not terminated early from Study X-TOLE2, X-TOLE3, or X-ACKT, met all eligibility requirements, and had no important protocol deviations (in the opinion of the sponsor) or adverse events (AEs) (in the opinion of the investigator) that would preclude the subject's entry into the long-term extension study.
3. In the opinion of the investigator, the subject is able to understand verbal and written instructions and will adhere to all study schedules and requirements.
4. Subject is able to keep accurate seizure diaries.
Exclusion Criteria:
1. Subject met any of the withdrawal criteria while in Study X-TOLE2, X-TOLE3, or X-ACKT.
2. Subject has any medical condition, personal circumstance, or ongoing AE (from Study X-TOLE2, X-TOLE3, or X-ACKT) that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study, or prevents adherence to the protocol.
3. Subject is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for treatment of epilepsy or any other medical condition during the study and until 28 days after completion of this study.
Primary outcome measure(s)
- The adverse events — From the start of treatment in the open-label extension (OLE) study through 8 weeks after the last dose.
To assess the safety and tolerability of XEN1101
Trial sites (152)
| Facility | City | Region | Status |
|---|---|---|---|
| Xenoscience | Phoenix | Arizona | |
| University of Arizona - Health Sciences | Tucson | Arizona | |
| Clinical Trials, Inc | Little Rock | Arkansas | |
| Brain Science Research Institute | Los Angeles | California | |
| UC Irvine Health | Orange | California | |
| University of California, Davis Clinical & Translational Science Center Clinical Research (CCRC) | Sacramento | California | |
| University of Colorado Hospital Anschutz Outpatient Pavilion | Aurora | Colorado | |
| Mayo Clinic Florida | Jacksonville | Florida | |
| Serenity Research Center, LLC | Miami | Florida | |
| Research Institute of Orlando, LLC | Orlando | Florida | |
| Panhandle Research & Medical Clinic | Pensacola | Florida | |
| University of South Florida | Tampa | Florida | |
| Encore Medical Research of Weston, LLC | Weston | Florida | |
| Hawaii Pacific Neuroscience | Honolulu | Hawaii | |
| Consultants in Epilepsy and Neurology | Boise | Idaho | |
| Indiana University School of Medicine | Indianapolis | Indiana | |
| The University of Kansas Medical Center | Kansas City | Kansas | |
| Bluegrass Epilepsy Research, LLC | Lexington | Kentucky | |
| Kentucky Clinic | Lexington | Kentucky | |
| MMP Neurology | Scarborough | Maine | |
| University of Maryland Medical Center | Baltimore | Maryland | |
| Mid-Atlantic Epilepsy and Sleep Center | Bethesda | Maryland | |
| Brigham and Women's Hospital | Boston | Massachusetts | |
| UMass Chan Medical School | Worcester | Massachusetts | |
| University of Michigan Hospitals | Ann Arbor | Michigan | |
| Wayne State University | Detroit | Michigan | |
| Michigan State University | East Lansing | Michigan | |
| Cornwell Health (Spectrum Health Hospitals) | Grand Rapids | Michigan | |
| Minneapolis Clinic of Neurology | Burnsville | Minnesota | |
| Saint Louis University Medical School | St Louis | Missouri | |
| Northeast Epilepsy Group | Hackensack | New Jersey | |
| Dent Neurosciences Research Center | Buffalo | New York | |
| New York University Comprehensive Epilepsy Center | New York | New York | |
| Mount Sinai Health | New York | New York | |
| SUNY Upstate Medical University | Syracuse | New York | |
| Montefiiore Medical Center | The Bronx | New York | |
| Onsite Clinical Solutions | Charlotte | North Carolina | |
| Duke University | Durham | North Carolina | |
| Meridian Clinical Research, LLC | Raleigh | North Carolina | |
| Summa Health | Akron | Ohio |
+ 112 more sites — see the full list on the official registry below.
More Xenon Pharmaceuticals Inc. trials in Mexico
Other trials for the same condition
Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
Active, not recruiting
Long-term Safety and Tolerability of BHV-7000
Enrolling by invitation
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05718817 on ClinicalTrials.gov ↗ ← All trials in Mexico