Actively Recruiting
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)
Led by Xenon Pharmaceuticals Inc. · Updated on 2026-05-14
360
Participants Needed
95
Research Sites
186 weeks
Total Duration
On this page
Sponsors
X
Xenon Pharmaceuticals Inc.
Lead Sponsor
W
Worldwide Clinical Trials
Collaborating Sponsor
AI-Summary
What this Trial Is About
The X-TOLE3 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.
CONDITIONS
Official Title
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed written consent before joining the study
- Have a diagnosis of focal epilepsy for 2 years or more according to ILAE 2017 classification
- Have tried and tolerated at least 2 antiseizure medications at adequate doses without sustained seizure freedom
- Be treated with a stable dose of 1 to 3 allowable antiseizure medications for at least one month before screening, during baseline, and throughout the double-blind treatment period
- Be able to keep accurate seizure diaries
You will not qualify if you...
- Electroencephalogram (EEG) shows patterns not consistent with focal seizures
- History of only focal aware non-motor seizures, psychogenic non-epileptic seizures, primary generalized seizures, or developmental epileptic encephalopathies such as Lennox-Gastaut syndrome
- Seizures caused by drug or alcohol use, infection, tumors, demyelinating or degenerative neurological diseases, metabolic illness, progressive structural brain lesions, encephalopathy, or progressive CNS disease
- History of status epilepticus or frequent seizures in the 12 months before study start where individual seizures cannot be counted
- History of neurosurgery for seizures less than 1 year before study start or radiosurgery less than 2 years before enrollment
- Any medical condition or personal situation that poses unacceptable risk or prevents following the study protocol as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 95 locations
1
Clinical Trials, Inc.
Little Rock, Arkansas, United States, 72205
Actively Recruiting
2
Rancho Research Institute
Downey, California, United States, 90242
Actively Recruiting
3
University of California Los Angeles (UCLA)
Los Angeles, California, United States, 90095
Actively Recruiting
4
University of California Irvine Health
Orange, California, United States, 92868
Actively Recruiting
5
Panhandle Research and Medical Clinic
Gulf Breeze, Florida, United States, 32651
Actively Recruiting
6
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
7
Consultants in Epilepsy and Neurology, PLLC
Boise, Idaho, United States, 83702
Actively Recruiting
8
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62794
Actively Recruiting
9
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States, 20817
Actively Recruiting
10
9D University Health Center
Detroit, Michigan, United States, 48201
Actively Recruiting
11
Northeast Regional Epilepsy Group
Hackensack, New Jersey, United States, 07601
Actively Recruiting
12
Five Towns Neuroscience Research
Woodmere, New York, United States, 11598
Withdrawn
13
Duke University Clinic
Durham, North Carolina, United States, 27705
Actively Recruiting
14
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
15
OhioHealth
Columbus, Ohio, United States, 43214
Actively Recruiting
16
Providence Neurological Specialities
Portland, Oregon, United States, 97225
Actively Recruiting
17
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
18
Austin Epilepsy Care Center
Austin, Texas, United States, 78758
Actively Recruiting
19
University of Utah Clinical Neurosciences Center
Salt Lake City, Utah, United States, 84132
Active, Not Recruiting
20
Hospital Ramos Mejia
Buenos Aires, Argentina, 1221
Active, Not Recruiting
21
Hospital De Alta Complejidad en Red el Cruce
Buenos Aires, Argentina, 1888
Active, Not Recruiting
22
Policlinico Lomas
Buenos Aires, Argentina, B1832BQD
Active, Not Recruiting
23
Instituto de Neurologia Cognitiva (INECO)
Buenos Aires, Argentina, C1060AAF
Active, Not Recruiting
24
Hospital Italiano
Buenos Aires, Argentina, C1199ABB
Active, Not Recruiting
25
Hospital Britanico de Buenos Aires
Buenos Aires, Argentina, C1280AEB
Active, Not Recruiting
26
STAT Resarch S.A.
Buenos Aires, Argentina
Active, Not Recruiting
27
CENyR Centro de Especialidades Neurologicas y Rehabilitacion
C.a.b.a., Argentina, C1424
Active, Not Recruiting
28
FLENI
C.a.b.a., Argentina, C1428DGG
Active, Not Recruiting
29
Hospital Córdoba
Córdoba, Argentina, X5000
Active, Not Recruiting
30
Hospital Central Ramon Carrilo
San Luis, Argentina, 5701
Active, Not Recruiting
31
Sanatori del Sur S.A.
San Miguel de Tucumán, Argentina
Active, Not Recruiting
32
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Active, Not Recruiting
33
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Active, Not Recruiting
34
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Active, Not Recruiting
35
Alfred Hospital
Melbourne, Victoria, Australia, 30004
Active, Not Recruiting
36
Austin Health
Melbourne, Victoria, Australia, 3084
Active, Not Recruiting
37
Royal Melbourne Hospital
Melbourne, Australia, 3050
Active, Not Recruiting
38
University Hospital Innsbruck
Innsbruck, Austria
Actively Recruiting
39
Universitätsklinik für Neurologie
Salzburg, Austria, 5020
Actively Recruiting
40
Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
41
Cliniques Universitaires Saint-Luc (UCL)
Brussels, Belgium, 1200
Actively Recruiting
42
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Actively Recruiting
43
MHATNPsy Sveti Naum EAD
Sofia, Bulgaria, 1113
Active, Not Recruiting
44
Medical center OPHTHA-NEURO
Sofia, Bulgaria, 1172
Withdrawn
45
Clinica Universidad de Los Andes
Santiago, Chile, 7620157
Withdrawn
46
Centro de Investigacion Clinica UC
Santiago, Chile, 833073
Active, Not Recruiting
47
CINSAN
Santiago, Chile, 8431657
Withdrawn
48
Hospital Clínico Viña del Mar
Viña del Mar, Chile
Active, Not Recruiting
49
University Hospital Center Osijek
Osijek, Croatia, 31000
Withdrawn
50
Clinical Hospital Center Rijeka, Klinika za Neurologiju
Rijeka, Croatia, 51000
Withdrawn
51
Poliklinika Bonifarm
Zagreb, Croatia, 10000
Actively Recruiting
52
University Hospital Center Zagreb
Zagreb, Croatia, 10000
Actively Recruiting
53
Poliklinika LF MEDICAL
Zagreb, Croatia, 1000
Actively Recruiting
54
EUC Hradec Kralove Clinic
Hradec Králové, Czechia
Withdrawn
55
Nemocnicni lekarna FN Motol / Motol University Hospital
Prague, Czechia, 150 06
Actively Recruiting
56
Forbeli s.r.o.
Prague, Czechia
Actively Recruiting
57
Kuopio University Hospital
Kuopio, Finland, 70210
Actively Recruiting
58
Hopital Neurologique Pierre Wertheimer
Bron, France, 69500
Actively Recruiting
59
Centre Hospitalier Universitaire de Lille (CHU de Lille)
Lille, France, 59037
Actively Recruiting
60
Hôpital de la Pitié Salpêtrière
Paris, France, 75013
Actively Recruiting
61
Hôpital Fondation A. de Rothschild
Paris, France, 75019
Actively Recruiting
62
Chu de Rennes Hôpital Pontchaillou
Rennes, France, 35033
Actively Recruiting
63
Hôpital de Hautepierre
Strasbourg, France, 67098
Actively Recruiting
64
Universitätsklinikum Aachen
Aachen, Germany, D-52074
Actively Recruiting
65
Krankenhaus Mara gGmbH
Bielefeld, Germany, 33617
Actively Recruiting
66
University Hospital Frankfurt, ZNN - Epilepsy Center Frankfurt Rhine-Main
Frankfurt, Germany, 60528
Actively Recruiting
67
Semmelweis Egyetem, Idegsebészeti és Neurointervenciós Klinika
Budapest, Hungary, 1145
Active, Not Recruiting
68
Hadassah Medical Center
Jerusalem, Israel, 9112001
Actively Recruiting
69
The Chaim Sheba Medical Center
Ramat Gan, Israel, 6265601
Actively Recruiting
70
Kaplan Medical Center
Rehovot, Israel, 76100
Actively Recruiting
71
The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Actively Recruiting
72
Ospedali Riuniti di Ancona
Ancona, Italy, 60126
Withdrawn
73
Università degli studi di Bari Aldo Moro
Bari, Italy, 70124
Actively Recruiting
74
Grupo Medico Camino
Benito Juárez, Mexico
Active, Not Recruiting
75
Human Science Research Trials
Mexico City, Mexico, 14050
Active, Not Recruiting
76
Axis Heilsa S. de R.L. de C.V. Althian
Monterrey, Mexico
Active, Not Recruiting
77
Neurocencias Esudios Clinicos S.C.
Sinaloa, Mexico, 80020
Active, Not Recruiting
78
Kempenhaeghe
Heeze, Netherlands
Actively Recruiting
79
COPERNICUS Podmiot Leczniczy
Gdansk, Poland
Actively Recruiting
80
NZOZ Neuromed M. i M. Nastaj Sp. P.
Lublin, Poland, 20-064
Withdrawn
81
Twoja Przychodnia Nowosolskie Centrum Medyczne
Nowa Sól, Poland, 67-100
Actively Recruiting
82
MTZ Clinical Research Powered by Pratia
Warsaw, Poland, 02-172
Actively Recruiting
83
Neurosphera Sp. z o.o.
Warsaw, Poland, 02-829
Actively Recruiting
84
Centro Hospitalar Universitário de Coimbra - CHUC
Coimbra, Portugal
Actively Recruiting
85
Hospital da Senhora da Oliveira
Guimarães, Portugal, 4835-044
Actively Recruiting
86
Centro Hospitalar de Lisboa Norte
Lisbon, Portugal, 1649-035
Actively Recruiting
87
Centro Hospitalar Lisboa Ocidental
Lisbon, Portugal
Actively Recruiting
88
Centro Hospitalar Universitário de Santo António
Porto, Portugal, 4099-001
Actively Recruiting
89
Hospital Pedro Hispano
Porto, Portugal, 4464-513
Actively Recruiting
90
Centro Hospitalar de Entre o Douro e Vouga
Santa Maria da Feira, Portugal, 520-211
Actively Recruiting
91
ULS de Trás-os-Montes e Alto Douro
Vila Real, Portugal, 5000-508
Actively Recruiting
92
Hospital Universitario Cruces
Barakaldo, Spain, 48903
Actively Recruiting
93
Hospital Unversitario Ramon y Cajal
Madrid, Spain, 28034
Actively Recruiting
94
Hospital Clínico San Carlos
Madrid, Spain, 28040
Actively Recruiting
95
Hospital universitario Fundación Jiménez Díaz
Madrid, Spain, 28040
Actively Recruiting
Research Team
X
Xenon Medical Affairs
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here