A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
Condition(s) studied
Investigational drug(s) / intervention(s)
XEN1101: XEN1101 capsules
Placebo: Placebo capsules
Study summary
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in primary generalized tonic-clonic seizures (PGTCS).
Eligibility
Primary outcome measure(s)
- Median percent change (MPC) in monthly (28 days) PGTCS frequency — Baseline through DBP (Week 12)
Median percent change (MPC) in monthly (28 days) PGTCS frequency from baseline through the DBP for XEN1101 versus placebo.
Trial sites (138)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama - Strada Patient Care Center, Neurology | Mobile | Alabama | Recruiting |
| Xenoscience | Phoenix | Arizona | Recruiting |
| University of Arizona - Health Science Center | Tucson | Arizona | Recruiting |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | Recruiting |
| Brain Science Research Institute | Los Angeles | California | Recruiting |
| University of California, Irvine - Health Neurology Services | Orange | California | Recruiting |
| University California, Davis Clinical & Translation Science Center Clinical Research (CCRC) | Sacramento | California | Withdrawn |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | Withdrawn |
| Mayo Clinic Florida | Jacksonville | Florida | Recruiting |
| Serenity Research Center, LLC | Miami | Florida | Recruiting |
| Research Institute of Orlando, LLC | Orlando | Florida | Terminated |
| Panhandle Research and Medical Clinic | Pensacola | Florida | Recruiting |
| Medsol Clinical Research Center Harbor Professional Centre | Port Charlotte | Florida | Recruiting |
| University of South Florida | Tampa | Florida | Recruiting |
| Encore Medical Research of Weston, LLC | Weston | Florida | Recruiting |
| Emory Brain Health Center | Atlanta | Georgia | Recruiting |
| Children's Healthcare of Atlanta | Atlanta | Georgia | Recruiting |
| Georgia Neurology & Sleep Medicine Associates | Suwanee | Georgia | Withdrawn |
| Hawaii Pacific Neuroscience, Comprehensive Epilepsy Center | Honolulu | Hawaii | Withdrawn |
| Consultants in Epilepsy and Neurology, PLLC | Boise | Idaho | Recruiting |
| Southern Illinois University School of Medicine | Springfield | Illinois | Recruiting |
| Indiana University School of Medicine | Indianapolis | Indiana | Withdrawn |
| University of Kansas Medical Center | Kansas City | Kansas | Recruiting |
| Bluegrass Epilepsy Research, LLC | Lexington | Kentucky | Recruiting |
| University of Kentucky Albert B. Chandler Hospital (UK Healthcare) | Lexington | Kentucky | Recruiting |
| University of Maryland Medical Center | Baltimore | Maryland | Recruiting |
| MedStar Franklin Square Medical Center | Baltimore | Maryland | Recruiting |
| Mid-Atlantic Epilepsy and Sleep Center | Bethesda | Maryland | Recruiting |
| Medstar Georgetown University Hospital | Clinton | Maryland | Recruiting |
| Brigham and Women's Hospital | Chestnut Hill | Massachusetts | Recruiting |
| UMass Memorial Medical Center | Worcester | Massachusetts | Withdrawn |
| University of Michigan Hospitals | Ann Arbor | Michigan | Recruiting |
| Wayne State University | Detroit | Michigan | Recruiting |
| Michigan State University Department of Neurology | East Lansing | Michigan | Recruiting |
| Spectrum Health | Grand Rapids | Michigan | Recruiting |
| Saint Louis University Medical School | St Louis | Missouri | Recruiting |
| Northeast Regional Epilepsy Group | Hackensack | New Jersey | Recruiting |
| Dent Neurosciences Research Facility | Amherst | New York | Terminated |
| SUNY Upstate Medical University | Syracuse | New York | Recruiting |
| Five Towns Neurology | Woodmere | New York | Withdrawn |
+ 98 more sites — see the full list on the official registry below.
More Xenon Pharmaceuticals Inc. trials in Italy
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 NCT05667142 on ClinicalTrials.gov ↗ ← All trials in Italy