Focal Onset SeizuresPhase 3X-TOLE2NCT05614063
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures
A Phase 3 study testing XEN1101 in people with Focal Onset Seizures, run by Xenon Pharmaceuticals Inc. at 125 sites in 18 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal Onset Seizures
- What is being tested?
- XEN1101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 380 participants
- Where
- 125 sitesin 18 countries
- Study dates
- 18 Nov 2022to 3 Feb 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study
- Diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy (2017). Subject must have had adequate trials of at least 2 ASMs, which were given (and tolerated) at adequate therapeutic doses, without achieving sustained seizure freedom.
- Treatment with a stable dose of 1 to 3 allowable current ASMs for at least one month prior to screening, during baseline, and throughout the duration of the DBP
- Able to keep accurate seizure diaries
Who cannot join
- Previously documented electroencephalogram which shows any pattern not consistent with focal etiology of seizures.
- History of focal aware non-motor seizures only, non-epileptic psychogenic seizure, primary generalized seizure, developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome.
- Seizures secondary to drug or alcohol use, ongoing infection, neoplasia, demyelinating disease, degenerative neurological disease, metabolic illness, progressive structural lesion, encephalopathy, or progressive central nervous system (CNS) disease.
- History of status epilepticus or repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted.
- History of neurosurgery for seizures <1 year prior to Visit 1, or radiosurgery <2 years prior to enrollment.
- Any medical condition or personal circumstance that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study or prevents adherence to the protocol.
Trial locations and contacts
125 sites in 18 countries.
125 sites in 18 countries
United States56 sites
Summa Health
Akron, Ohio, 44304
University of Michigan
Ann Arbor, Michigan, 48109
Emory Brain Health Center
Atlanta, Georgia, 30329
Anschutz Health Sciences
Aurora, Colorado, 80011
Austin Epilepsy Care Center (AECC)
Austin, Texas, 78758
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
Consultants in Epilepsy and Neurology
Boise, Idaho, 83702
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dent Neurosciences Research Center
Buffalo, New York, 14226
Minneapolis Clinic of Neurology
Burnsville, Minnesota, 55337
Onsite Clinical Solutions, LLC
Charlotte, North Carolina, 28211
MedStar Georgetown University Hospital
Clinton, Maryland, 20735
Duke Neurology
Durham, North Carolina, 27713
Michigan State University
East Lansing, Michigan, 48824
ANESC Research
El Paso, Texas, 79912
Cornwell Health
Grand Rapids, Michigan, 49506
Northeast Epilepsy Group
Hackensack, New Jersey, 07601
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817
UT Physicians Epilepsy Clinic
Houston, Texas, 77030
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
Clinical Trials, Inc
Little Rock, Arkansas, 72205
Brain Science Research Institute
Los Angeles, California, 90025
Serenity Research
Miami, Florida, 33176
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Strada Patient Care Center
Mobile, Alabama, 36604
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
Research Institute of Orlando, LLC
Orlando, Florida, 32806
Panhandle Research & Medical Clinic
Pensacola, Florida, 32503
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Temple University Hospital
Philadelphia, Pennsylvania, 19140-4105
Xenoscience
Phoenix, Arizona, 85004
Medsol Clinical Research Center
Port Charlotte, Florida, 33952
Providence Brain & Spine Institute
Portland, Oregon, 97225
Meridian Clinical Research, LLC
Raleigh, North Carolina, 27607
Carilion Clinic - Neurology
Roanoke, Virginia, 24013
University of California, David Clinical & Translational Science Center Clinical Research (CCRC)
Sacramento, California, 95817
UT Health San Antonio
San Antonio, Texas, 78229
MaineHealth Neurology - Scarborough
Scarborough, Maine, 04074
University of Washington Main Hospital
Seattle, Washington, 98104
Saint Louis University Medical School - Neurosciences Clinical Research Unit
St Louis, Missouri, 63104
Washington University, St. Louis
St Louis, Missouri, 63110
SUNY Upstate Medical University
Syracuse, New York, 13210
University of South Florida
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10467-2401
University of Arizona, Health Sciences Center
Tucson, Arizona, 85724
Sentara Neurology Specialists
Virginia Beach, Virginia, 23456
Encore Medical Research of Weston, LLC
Weston, Florida, 33021
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
Spain10 sites
Unitat d'Assaigs Clínics. Servei de Farmàcia
Barcelona, 08036
Hospital Ramón y Cajal
Madrid, 28034
Hospital Ruber Internacional
Madrid, 28034
Hospital Vithas La Milagrosa
Madrid, 28034
Hospital Clinico San Carlos
Madrid, 28040
IIS-Fundacion Jimenez Diaz/Farmacia
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Regional De Malaga
Málaga, 29010
Hospital Universitario y Politecnico La Fe
Valencia, 46026
Hospital Clínico Universitario Valladolid
Valladolid, 47003
Australia9 sites
The University of Queensland (UQ) - Mater Research Institute (MRI)
Brisbane, Queensland, 4101
Royal Prince Alfred Hospital (RAPH)
Camperdown, New South Wales, 2050
St Vincent's Hospital Melbourne
Fitzroy, Melbourne, 3065
Austin Health Pharmacy Clinical Trials
Heidelberg, Victoria, 3079
The Alfred Hospital (Alfred Health)
Melbourne, Victoria, 3004
The Royal Melbourne Hospital
Melbourne, 3052
Prince of Wales Hospital
Sydney, New South Wales, 2031
Southern Neurology
Sydney, New South Wales, 2217
Westmead Hospital
Westmead, New South Wales, 2145
Argentina8 sites
INECO and Favoloro Fundation
Buenos Aires, 1060
Hospital General de Agudos J.M. Ramos Mejia
Buenos Aires, 1221
Hospital De Alta Complejidad en Red el Cruce Nestor Kirchner - SAMIC
Buenos Aires, B1888AAE
STAT Research S.A.
Buenos Aires, C1023AAB
Hospital Italiano
Buenos Aires, C1199ABB
CENyR
Caba, C1424
Hospital Córdoba
Córdoba, CP 5000
Sanatorio del Sur S.A.
San Miguel de Tucumán, 4000
Germany8 sites
Epilepsy Center Bethel
Bielefeld, 33617
Universitatsklinikum Bonn
Bonn
Epilepsiezentrum Frankfurt Rhein-Main
Frankfurt, 60528
University Medical Center Freiburg
Freiburg im Breisgau, 79106
Philipps-Universität Marburg
Marburg, 35043
LMU Munich, Department of Neurology
Munich, 81277
Universitätsklinikum Tübingen
Tübingen, 72076
Universitatsklinik fur neurologie, universitats - und Rehabilitationskliniken Ulm
Ulm, 89081
United Kingdom7 sites
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B152GW
University Hospital of Wales
Cardiff, CF144XW
Leeds Teaching Hospitals NHS Trust
Leeds, LS1 3EX
St. George's Hospital NHS Foundation Trust
London, SW17 0QT
Royal London Hospital for Integrated Medicine
London, WC1N 3HR
John Radcliffe Hospital
Oxford, OX3 9DU
Northern Care Alliance NHS Foundation Trust, Salford Care Organisation
Salford, M6 8HD
Italy4 sites
Istituto delle Scienze Neurologiche di Bologna
Bologna, 40139
Università Degli Studi Gabriele d'Annunzio Di Chieti
Pescara, 66100
Azienda Ospedaliero Universitaria Pisana
Pisa, 56100
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Rome, 00186
Poland4 sites
Centrum Medyczne Neuromed
Bydgoszcz, 85-163
NZOZ Novo-Med
Katowice, 40-650
Twoja Przychodnia NCM
Nowa Sól, 67-100
Neurosphera Sp. z o.o.
Warsaw, 02-829
Canada3 sites
Center For Neurologic Research
Lethbridge, Alberta, T1J 0N9
London Health Sciences Centre
London, Ontario, N6A 5A5
Le Centre Hospitalier de l'Universite' de Montreal (CHUM)
Montreal, Quebec, H2X3E4
Portugal3 sites
Unidade Local de Saúde de São João
Porto, 4200-450
Hospital Pedro Hispano
Porto, 4464-513
Centro Hospitalar de Entre o Douro e Vouga
Santa Maria da Feira, 4520-220
Chile2 sites
Centro de investigación Clinica UC
Santiago, 833073
Hospital Clínico Vina del Mar
Viña del Mar, 2520612
Georgia2 sites
American Hospital Network LLC
Tbilisi, 0121
Institute of Neurology and Neuropsychology
Tbilisi, 0186
Latvia2 sites
Pauls Stradina Clinical university hospital
Riga, LV-1002
Riga East University Hospital
Riga, LV-1024
Mexico2 sites
Human Science Research Trials S. de R.L. de C.V.
Mexico City, 14050
Neurocencias Esudios Clinicos SC
Sinaloa, 80020
New Zealand2 sites
University of Auckland
Auckland, 1023
Waikato Hospital
Hamilton, 3204
About this study
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
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.
Read the detailed description
Approximately 360 subjects will be randomized in a blinded manner to one of two active treatment groups or placebo in a 1:1:1 fashion (XEN1101 25 mg : 15 mg : Placebo). Eligible subjects will have up to 9.5 weeks of baseline to assess frequency of seizures, followed by 12 weeks of blinded treatment. In order to be included in the study, subjects must be treated with a stable dose of 1 to 3 allowable antiseizure medications (ASMs) for at least one month prior to screening, during baseline, and throughout the double-blind treatment period (DBP) of the study. During the DBP, subjects will be instructed to orally take XEN1101 or placebo once daily with an evening meal.
Subjects who complete the 12-week DBP will have the opportunity to qualify and enroll in a separate open-label extension (OLE) study for continued treatment with XEN1101. Subjects who do not enroll in the OLE will enter a 8-week post treatment follow-up period.
- Conditions
- Focal Onset Seizures
- Being tested
- XEN1101, Placebo
- Keywords
- Epilepsy
- Medical subject headings
- Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XEN1101Drug
Also called Azetukalner
XEN1101 Capsules
PlaceboDrug
Placebo Capsules
| Study group | Role | What they receive |
|---|---|---|
| XEN1101 25 mg/day | Experimental | XEN1101 25 mg/day Receives: Drug: XEN1101 |
| XEN1101 15 mg/day | Experimental | XEN1101 15 mg/day Receives: Drug: XEN1101 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median percent change (MPC) in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo.
Measured: From baseline through to the double blind period (week 12)
Secondary outcomes (4)
Proportion of subjects experiencing ≥50% reduction in monthly (28 days) focal seizure frequency from baseline through the DBP for XEN1101 versus placebo.
Measured: From baseline through to the double blind period (week 12)
MPC in weekly (7 days) focal seizure frequency from baseline to Week 1 for XEN1101 versus placebo.
Measured: From baseline through to the week 1
Proportion of subjects experiencing "at least much improved" (including "much" and "very much improved") in Patient Global Impression of Change (PGI-C).
Measured: From baseline through to the double blind period (week 12)
To assess adverse events as criteria for safety and tolerability of XEN1101
Measured: From screening through to 56 days post-final dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start18 Nov 2022
- Primary completion12 Jan 2026
- Study completion3 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal Onset SeizuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xenon Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Xenon Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614063
- Sponsor's protocol ID
- XPF-010-301
- Other IDs
- 2022-502000-73-00
- Acronym
- X-TOLE2
- Status last verified
- May 2026
- First submitted
- 6 Nov 2022
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05614063
- Acronym / sponsor ID
- X-TOLE2 / XPF-010-301
- Conditions
- Focal Onset Seizures
- Keywords
- Epilepsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Xenon Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 3 Feb 2026 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately 360 subjects will be randomized in a blinded manner to one of two active treatment groups or placebo in a 1:1:1 fashion (XEN1101 25 mg : 15 mg : Placebo). Eligible subjects will have up to 9.5 weeks of baseline to assess frequency of seizures, followed by 12 weeks of blinded treatment. In order to be included in the study, subjects must be treated with a stable dose of 1 to 3 allowable antiseizure medications (ASMs) for at least one month prior to screening, during baseline, and throughout the double-blind treatment period (DBP) of the study. During the DBP, subjects will be instructed to orally take XEN1101 or placebo once daily with an evening meal.
Subjects who complete the 12-week DBP will have the opportunity to qualify and enroll in a separate open-label extension (OLE) study for continued treatment with XEN1101. Subjects who do not enroll in the OLE will enter a 8-week post treatment follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| XEN1101 25 mg/day | Experimental | Drug: XEN1101XEN1101 25 mg/day |
| XEN1101 15 mg/day | Experimental | Drug: XEN1101XEN1101 15 mg/day |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study
- Diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy (2017). Subject must have had adequate trials of at least 2 ASMs, which were given (and tolerated) at adequate therapeutic doses, without achieving sustained seizure freedom.
- Treatment with a stable dose of 1 to 3 allowable current ASMs for at least one month prior to screening, during baseline, and throughout the duration of the DBP
- Able to keep accurate seizure diaries
Key exclusion criteria (6 listed)
- Previously documented electroencephalogram which shows any pattern not consistent with focal etiology of seizures.
- History of focal aware non-motor seizures only, non-epileptic psychogenic seizure, primary generalized seizure, developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome.
- Seizures secondary to drug or alcohol use, ongoing infection, neoplasia, demyelinating disease, degenerative neurological disease, metabolic illness, progressive structural lesion, encephalopathy, or progressive central nervous system (CNS) disease.
- History of status epilepticus or repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted.
- History of neurosurgery for seizures <1 year prior to Visit 1, or radiosurgery <2 years prior to enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XEN1101Also: AzetukalnerXEN1101 Capsules | Drug | XEN1101 15 mg/day, XEN1101 25 mg/day |
| PlaceboPlacebo Capsules | Drug | Placebo |
Primary outcome
Median percent change (MPC) in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo.
Time frame: From baseline through to the double blind period (week 12)
4 secondary outcomes
Proportion of subjects experiencing ≥50% reduction in monthly (28 days) focal seizure frequency from baseline through the DBP for XEN1101 versus placebo.
Time frame: From baseline through to the double blind period (week 12)
MPC in weekly (7 days) focal seizure frequency from baseline to Week 1 for XEN1101 versus placebo.
Time frame: From baseline through to the week 1
Proportion of subjects experiencing "at least much improved" (including "much" and "very much improved") in Patient Global Impression of Change (PGI-C).
Time frame: From baseline through to the double blind period (week 12)
To assess adverse events as criteria for safety and tolerability of XEN1101
Time frame: From screening through to 56 days post-final dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Xenon Pharmaceuticals Inc.
125 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing XEN1101 in people with Focal Onset Seizures, run by Xenon Pharmaceuticals Inc. at 125 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 125 sites in United States, Spain, Australia, Argentina, Germany and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median percent change (MPC) in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo. (time frame: From baseline through to the double blind period (week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.