Actively Recruiting
A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
Led by Xenon Pharmaceuticals Inc. · Updated on 2026-03-12
160
Participants Needed
138
Research Sites
224 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
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).
CONDITIONS
Official Title
A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is properly informed of the study and gives written informed consent (or assent with parent/legal guardian consent for adolescents).
- Subject is 12 years of age or older with a BMI of 40 kg/m2 or less at Visit 1.
- Subject has had adequate trials of at least 2 anti-seizure medications at therapeutic doses without sustained seizure freedom.
- Subject has probable or possible primary generalized tonic-clonic seizures for at least 1 year in the setting of generalized epilepsy.
- Subject is approved by The Epilepsy Study Consortium.
- Subject is on a stable dose of 1 to 3 allowable anti-seizure medications for at least 1 month before screening and during the study.
- Subject can keep accurate seizure diaries.
- During the last 56 days before randomization, subject had at least 1 primary generalized tonic-clonic seizure in each 4-week period.
- Seizure diary was completed at least 80% of days during the last 56 days before randomization.
- Subject did not change, stop, or start any new anti-seizure medication during the baseline period and plans to maintain stable doses during the treatment period.
You will not qualify if you...
- Subject had status epilepticus within 12 months before Visit 1.
- Subject has history of repetitive seizures within 12 months before Visit 1 where seizures cannot be counted.
- Subject has history of non-epileptic psychogenic seizures.
- Subject has a diagnosis of focal-onset seizures.
- Subject has or had developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome.
- Subject has seizures caused by drug or alcohol use, infection, cancer, demyelinating disease, degenerative neurological disease, metabolic illness, progressive brain lesion, encephalopathy, or progressive central nervous system disease.
- Subject had neurosurgery for seizures less than 1 year before Visit 1 or radiosurgery less than 2 years before Visit 1.
- Subject has schizophrenia, other psychotic disorders, bipolar disorder, obsessive-compulsive disorder, or serious mental health disorder; or uncontrolled major depression needing medication changes.
- Subject has significant lab abnormalities or medical problems based on exam, vital signs, or ECG, including long QT syndrome or QTcF longer than 450 msec.
- Any personal circumstance preventing adherence to the study protocol.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 138 locations
1
University of Alabama - Strada Patient Care Center, Neurology
Mobile, Alabama, United States, 36604
Actively Recruiting
2
Xenoscience
Phoenix, Arizona, United States, 85004
Actively Recruiting
3
University of Arizona - Health Science Center
Tucson, Arizona, United States, 85724
Actively Recruiting
4
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
5
Brain Science Research Institute
Los Angeles, California, United States, 90025
Actively Recruiting
6
University of California, Irvine - Health Neurology Services
Orange, California, United States, 92868
Actively Recruiting
7
University California, Davis Clinical & Translation Science Center Clinical Research (CCRC)
Sacramento, California, United States, 95817
Withdrawn
8
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
9
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
10
Serenity Research Center, LLC
Miami, Florida, United States, 33176
Actively Recruiting
11
Research Institute of Orlando, LLC
Orlando, Florida, United States, 32806
Terminated
12
Panhandle Research and Medical Clinic
Pensacola, Florida, United States, 32503
Actively Recruiting
13
Medsol Clinical Research Center Harbor Professional Centre
Port Charlotte, Florida, United States, 33952
Actively Recruiting
14
University of South Florida
Tampa, Florida, United States, 33606
Actively Recruiting
15
Encore Medical Research of Weston, LLC
Weston, Florida, United States, 33331
Actively Recruiting
16
Emory Brain Health Center
Atlanta, Georgia, United States, 30329
Actively Recruiting
17
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30342
Actively Recruiting
18
Georgia Neurology & Sleep Medicine Associates
Suwanee, Georgia, United States, 30024
Withdrawn
19
Hawaii Pacific Neuroscience, Comprehensive Epilepsy Center
Honolulu, Hawaii, United States, 96817
Actively Recruiting
20
Consultants in Epilepsy and Neurology, PLLC
Boise, Idaho, United States, 83702
Actively Recruiting
21
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62794
Actively Recruiting
22
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Withdrawn
23
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
24
Bluegrass Epilepsy Research, LLC
Lexington, Kentucky, United States, 40504
Actively Recruiting
25
University of Kentucky Albert B. Chandler Hospital (UK Healthcare)
Lexington, Kentucky, United States, 40536
Actively Recruiting
26
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
27
MedStar Franklin Square Medical Center
Baltimore, Maryland, United States, 21237
Actively Recruiting
28
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States, 20817
Actively Recruiting
29
Medstar Georgetown University Hospital
Clinton, Maryland, United States, 20735
Actively Recruiting
30
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States, 02467
Actively Recruiting
31
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
Actively Recruiting
32
University of Michigan Hospitals
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
33
Wayne State University
Detroit, Michigan, United States, 48201
Actively Recruiting
34
Michigan State University Department of Neurology
East Lansing, Michigan, United States, 48824
Actively Recruiting
35
Spectrum Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
36
Saint Louis University Medical School
St Louis, Missouri, United States, 14624
Actively Recruiting
37
Northeast Regional Epilepsy Group
Hackensack, New Jersey, United States, 07601
Actively Recruiting
38
Dent Neurosciences Research Facility
Amherst, New York, United States, 14226
Terminated
39
SUNY Upstate Medical University
Syracuse, New York, United States, 13201
Actively Recruiting
40
Five Towns Neurology
Woodmere, New York, United States, 11598
Withdrawn
41
Atrium Health
Charlotte, North Carolina, United States, 28203
Actively Recruiting
42
Onsite Clinical Solutions, LLC
Charlotte, North Carolina, United States, 28211
Actively Recruiting
43
Duke University Clinical Research
Durham, North Carolina, United States, 27710
Actively Recruiting
44
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27104
Actively Recruiting
45
Summa Health Clinical Research Center
Akron, Ohio, United States, 44304
Actively Recruiting
46
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
47
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
48
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Actively Recruiting
49
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
50
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
51
UPMC Comprehensive Epilepsy Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
52
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
Withdrawn
53
ANESC Research
El Paso, Texas, United States, 79912
Actively Recruiting
54
UTHealth Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
55
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
56
University of Utah Clinical Neurosciences Center
Salt Lake City, Utah, United States, 84132
Actively Recruiting
57
Sentara Neurology Specialists
Virginia Beach, Virginia, United States, 23456
Actively Recruiting
58
University of Washington, Regional Epilepsy Center at Harborview Medical Center
Seattle, Washington, United States, 98104
Actively Recruiting
59
Advocate Aurora Research institute, St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Actively Recruiting
60
Hospital General de Agudos J.M. Ramos Mejia
Buenos Aires, Argentina, 1221
Actively Recruiting
61
STAT Research S.A.
Buenos Aires, Argentina, C1023AAB
Actively Recruiting
62
Hospital Italiano
Buenos Aires, Argentina, C1181ACH
Actively Recruiting
63
Sanatorio del Sur S.A
San Miguel de Tucumán, Argentina, 4000
Actively Recruiting
64
Southern Neurology
Kogarah, New South Wales, Australia, 2217
Withdrawn
65
Mater Misericordiae Ltd
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
66
The Alfred Hospital
Melbourne, VC, Australia, 3004
Actively Recruiting
67
Austin Health Pharmacy Clinical Trials
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
68
St Vincent's Hospital Melbourne, Clinical Neurosciences
Melbourne, Victoria, Australia, 3065
Actively Recruiting
69
The Royal Melbourne Hospital
Parkville, Australia, 3050
Actively Recruiting
70
University Hospital Innsbruck
Innsbruck, Austria, 6020
Actively Recruiting
71
Universitaetsklinik fuer Kinder
Linz, Austria, 4021
Actively Recruiting
72
Universitätsklinik für Neurologie
Salzburg, Austria, 5020
Actively Recruiting
73
Universitätsklinik für Neurologie, Medizinische Universität Wien
Vienna, Austria, 1090
Actively Recruiting
74
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Actively Recruiting
75
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Actively Recruiting
76
Multiprofile hospital for active treatment Puls AD
Blagoevgrad, Bulgaria, 2700
Actively Recruiting
77
MHATNP 'Sveti Naum' EAD
Sofia, Bulgaria, 1113
Actively Recruiting
78
First University Multiprofile Hospital for Active Treatment Sofia Sv. Joan Krastitel
Sofia, Bulgaria, 1142
Withdrawn
79
Center for Neurologic Research
Lethbridge, Alberta, Canada, T1J 0N9
Actively Recruiting
80
Children and Women's Health Centre of BC (BC Children's Hospital)
Vancouver, British Columbia, Canada, V6H 3V4
Actively Recruiting
81
London Health Sciences Center
London, Ontario, Canada, N6A5A5
Actively Recruiting
82
Le Centre Hospitalier de l'Universite' de Montreal (CHUM)
Montreal, Quebec, Canada, H2X 0C1
Actively Recruiting
83
Centro de investigación Clinica UC-CICUC
Santiago, Chile
Actively Recruiting
84
Clinical Hospital Center Osijek
Osijek, Croatia, 310 00
Withdrawn
85
Clinical Hospital Center Rijeka
Rijeka, Croatia, 510 00
Withdrawn
86
University Hospital Center Zagreb
Zagreb, Croatia, 100 00
Withdrawn
87
Fakultni nemocnice v Motole Neurologicka klinika 2. LF UK a FN Motol
Prague, Czechia, 150 06
Withdrawn
88
CHU de Lille, Hôpital Roger Salengro - Neurophysiologie clinique
Lille, France, 59037
Actively Recruiting
89
Hopital Neurologique Pierre Wertheimer, Hospices Civils de Lyon
Lyon, France, 9003
Actively Recruiting
90
Hôpital Fondation A. de Rothschild
Paris, France, 75019
Actively Recruiting
91
CHU de Rennes - Hôpital Pontchaillou
Rennes, France, 35033
Actively Recruiting
92
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, France, 67098
Actively Recruiting
93
Universitätsklinikum Aachen
Aachen, Germany, D-52074
Actively Recruiting
94
Vivantes Humboldt Klinikum
Berlin, Germany, 13509
Withdrawn
95
Bethel Epilepsy Centre
Bielefeld, Germany, 33617
Actively Recruiting
96
Universitätsklinikum Frankfurt
Frankfurt, Germany, 60528
Actively Recruiting
97
Epilepsiezentrum im Neuozentrum
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
98
Philipps-Universität Marburg
Marburg, Germany, 35043
Actively Recruiting
99
Klinikum der Universität München
München, Germany, 81377
Actively Recruiting
100
Epilepsiezentrum Kleinwachau gemeinnützige GmbH
Radeberg, Germany, 01454
Withdrawn
101
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Actively Recruiting
102
Universitätsklinikum Ulm
Ulm, Germany, 89081
Actively Recruiting
103
Hadassah University Medical Center
Jerusalem, Israel, 9112001
Actively Recruiting
104
The Chaim Sheba Medical Center
Ramat Gan, Israel, 6265601
Actively Recruiting
105
Kaplan Medical Center
Rehovot, Israel, 7661041
Actively Recruiting
106
The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Actively Recruiting
107
Azienda Ospedaliero Universitaria Ospedali Riuniti Ancona
Ancona, Italy, 60126
Withdrawn
108
Università Degli Studi Gabriele d'Annunzio Di Chieti
Chieti, Italy, 66100
Actively Recruiting
109
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56126
Actively Recruiting
110
Ospedalo Pediatrico Bambino Gesu
Roma, Italy, 00165
Actively Recruiting
111
Policlinico Umberto I
Roma, Italy, 185
Actively Recruiting
112
Grupo Medico Camino SC
Mexico City, Mexico, 03310
Actively Recruiting
113
Human Science Research Trials S. de R.L. de C.V.
Mexico City, Mexico, 14050
Actively Recruiting
114
Neurociencias Estudios Clínicos S.C
Sinaloa, Mexico, 80020
Actively Recruiting
115
Kempenhaeghe
Heeze, Netherlands, 5591BL VE
Actively Recruiting
116
Centrum Medyczne Neuromed
Bydgoszcz, Poland, 85-163
Actively Recruiting
117
COPERNICUS Podmiot Leczniczy Sp. z o.o.
Gdansk, Poland, 80-803
Actively Recruiting
118
Novo-Med Zielinski I Wspolnicy Sp. J.
Katowice, Poland, 40-584
Actively Recruiting
119
NZOZ Neuromed M. i M.
Lublin, Poland, 20-064
Withdrawn
120
Twoja Przychodnia Nowosolskie Centrum Medyczne
Nowa Sól, Poland, 67-100
Actively Recruiting
121
Centro Hospitalar Universitário de Coimbra (CHUC)
Coimbra, Portugal, 3000-075
Actively Recruiting
122
Hospital da Senhora da Oliveira
Guimarães, Portugal, 4835-044
Actively Recruiting
123
Centro Hospitalar Lisboa Ocidental, Hospital Egas Moniz
Lisbon, Portugal, 1349-019
Actively Recruiting
124
Centre Hospitalar Universitario de Lisboa Norte (CHULN)
Lisbon, Portugal, 1649-035
Actively Recruiting
125
Unidade Local de Saúde de Matosinhos
Matosinhos Municipality, Portugal, 4450-024
Actively Recruiting
126
Centro Hospitalar Universitário de Santo António
Porto, Portugal, 4050-342
Actively Recruiting
127
Centro Hospitalar de Entre o Douro e Vouga
Santa Maria da Feira, Portugal, 4520-211
Actively Recruiting
128
Hospital Universitario 12 de Octubre
Madrid, Spain, 280 41
Actively Recruiting
129
Hospital Universitario Vithas Madrid La Milagrosa
Madrid, Spain, 28010
Withdrawn
130
Hospital Regional Universitario de Málaga
Málaga, Spain, 29010
Withdrawn
131
Hospital Clinico Universitario de Valladolid
Valladolid, Spain, 47003
Withdrawn
132
Hospital Clinico Viña del Mar
Valparaíso, Spain, 2520612
Actively Recruiting
133
University Hospital of Wales
Cardiff, Wales, United Kingdom, CF14 4XW
Actively Recruiting
134
Mid Yorkshire Hospitals NHS Trust
Wakefield, West Yorkshire, United Kingdom, WF1 4DG
Actively Recruiting
135
St George's University Hospitals NHS Foundation Trust
London, United Kingdom, SW17 0QT
Actively Recruiting
136
University College London Hospitals NHS Foundation Trust
London, United Kingdom, WC1N 3BG
Actively Recruiting
137
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Actively Recruiting
138
Salford Royal NHS Foundation Trust - Greater Manchester Neuroscience Centre (GMNC)
Salford, United Kingdom, M6 8HD
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
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