A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
X-TOLE
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 as Adjunctive Therapy in Focal-onset Epilepsy, With an Open-label Extension
2 other identifiers
interventional
325
9 countries
95
Brief Summary
The XEN1101 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of increasing doses of XEN1101 administered as adjunctive treatment in adult patients diagnosed with focal epilepsy, followed by an optional open-label extension (OLE).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2019
Longer than P75 for phase_2
95 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 2, 2019
CompletedFirst Posted
Study publicly available on registry
January 8, 2019
CompletedStudy Start
First participant enrolled
January 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 2, 2021
CompletedResults Posted
Study results publicly available
September 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
ExpectedSeptember 24, 2024
September 1, 2024
2.6 years
January 2, 2019
August 16, 2024
September 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Median Percent Change in Focal Seizure Frequency
Median percent change in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo
From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56)
Secondary Outcomes (2)
50% XEN1101 Response Rate
From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56)
Percent Change in Focal Seizure Frequency Over Time
From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56)
Study Arms (4)
25 mg XEN1101
EXPERIMENTALCapsule filled with 25 mg XEN1101
20 mg XEN1101
EXPERIMENTALCapsule filled with 20 mg XEN1101
10 mg XEN1101
EXPERIMENTALCapsule filled with 10 mg XEN1101
Placebo
PLACEBO COMPARATORPlacebo capsule
Interventions
Eligibility Criteria
You may qualify if:
- Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study
- BMI ≤40 kg/m2
- Diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy \[ILAE\] Classification of Epilepsy (2017)
- Prior neuroimaging within the last 10 years and documentation is available
- Treatment with a stable dose of 1 to 3 allowable current AEDs for at least one month prior to screening, during baseline, and throughout the duration of the DBP
- Must be willing to comply with the contraception requirements
- Males must agree not to donate sperm from the time of the first administration of study drug until 6 months after the last dose. Females must agree not to donate ova from the time of the first administration of study drug until 6 months after the last dose.
- Able to keep accurate seizure diaries
You may not qualify if:
- History of pseudoseizures, psychogenic seizures, primary generalized seizure, or focal aware non-motor seizures only
- Presence or previous history of Lennox-Gastaut syndrome
- Seizures secondary to other diseases or conditions
- History of repetitive seizures within the last 12 months where the individual seizures cannot be counted
- History of neurosurgery for seizures \<1 year prior to enrollment, or radiosurgery \<2 years prior to enrollment
- Schizophrenia and other psychotic disorders, or active suicidal plan/intent in the past 6 months, or a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt
- History or presence of any significant medical or surgical condition or uncontrolled medical illness at screening, or history of cancer within the past 2 years, with the exception of appropriately treated basal cell or squamous cell carcinoma
- Any clinically significant abnormalities on pre-study physical examination, vital signs, laboratory values or ECG indicating a medical problem that would preclude study participation including but not limited to:
- History of presence of long QT syndrome; QTcF \> 450 msec at baseline; family history of sudden death of unknown cause
- History of skin or retinal pigment epithelium abnormalities caused by ezogabine
- Past use of vigabatrin without stable visual fields tested twice over the 12 months after the last dose of vigabatrin (concomitant use of vigabatrin is not allowed)
- If felbamate is used as a concomitant AED, patients must be taking it for at least 2 years, with a stable dose for 2 months (or no less than 49 days) and acceptable hematology and LFT history and values prior to Screening. If received in the past, felbamate must have been discontinued 2 months (or no less than 49 days) prior to Screening.
- Have had multiple drug allergies or a severe drug reaction to an AED(s), including dermatological (e.g., Stevens-Johnson syndrome), hematological, or organ toxicity reactions
- Current use of a ketogenic diet
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xenon Pharmaceuticals Inc.lead
- Novotech Health Holdings Pte. Ltd.collaborator
Study Sites (95)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Strada Patient Care Center
Mobile, Alabama, 36604, United States
Xenoscience, Inc.
Phoenix, Arizona, 85004, United States
Clinical Trials, Inc.
Little Rock, Arkansas, 72205, United States
Altman Clinical Translational Research Institute (ACTRI)
La Jolla, California, 92037, United States
California Pacific Medical Center (CPMC) - Sutter Pacific Epilepsy Program
San Francisco, California, 94109, United States
University of Colorado Hospital Anschutz Outpatient Pavilion
Aurora, Colorado, 80045, United States
University of Florida Jacksonville
Jacksonville, Florida, 32209, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Visionary Investigators Network
Miami, Florida, 33133, United States
Don Clinical Research Center
Miami, Florida, 33136, United States
The Neurology Research Group, LLC.
Miami, Florida, 33176, United States
Research Institute of Orlando, LLC
Orlando, Florida, 32806, United States
Medsol Clinical Research Center
Port Charlotte, Florida, 33952, United States
Tallahassee Neurological Clinic
Tallahassee, Florida, 32308, United States
University of South Florida
Tampa, Florida, 33606, United States
Georgia Neurology and Sleep Medicine Associate
Suwanee, Georgia, 30024, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817, United States
Consultants in Epilepsy and Neurology, PLLC
Boise, Idaho, 83702, United States
Northwestern Medical Group, Department of Neurology
Chicago, Illinois, 60611, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Bluegrass Epilepsy Research
Lexington, Kentucky, 40504, United States
Maine Medical Partners Neurology
Scarborough, Maine, 04074, United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, 20817, United States
Boston Neuro Research Center
South Dartmouth, Massachusetts, 02747, United States
Minneapolis Clinic of Neurology, Ltd.
Golden Valley, Minnesota, 55422, United States
Minnesota Epilepsy Group, P. A.
Saint Paul, Minnesota, 55102, United States
Northeast Regional Epilepsy Group
Hackensack, New Jersey, 07601, United States
Institute of Neurology and Neurosurgery at Saint Barnabas
Livingston, New Jersey, 07039, United States
Northeast Regional Epilepsy Group
Morristown, New Jersey, 07960, United States
Dent Neurosciences Research Center
Amherst, New York, 14226, United States
NYU Langone Medical Center/NYU School of Medicine
New York, New York, 10016, United States
Northwell Health - Lenox Hill
New York, New York, 10075, United States
SUNY Upstate Medical University Institute for Human Performance
Syracuse, New York, 13210, United States
Five Towns Neuroscience Research
Woodmere, New York, 11598, United States
Asheville Neurology Specialists, PA
Asheville, North Carolina, 28806, United States
UC Gardner Neuroscience Institute
Cincinnati, Ohio, 45219, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
University of Toledo Medical Center
Toledo, Ohio, 43606, United States
Providence Neurological Specialties East
Portland, Oregon, 97213, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Comprehensive Epilepsy Center
Philadelphia, Pennsylvania, 19107, United States
Allegheny Neurological Associates
Pittsburgh, Pennsylvania, 15212, United States
Vanderbilt Epilepsy Clinic
Nashville, Tennessee, 37232, United States
Austin Epilepsy Care Center
Austin, Texas, 78758, United States
James W. Aston Ambulatory Care Center
Dallas, Texas, 75390, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900, United States
University of Utah Health Clinical Neurosciences Center
Salt Lake City, Utah, 84132, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Virginia Commonwealth University
Richmond, Virginia, 23219, United States
Carilion Neurology Clinic
Roanoke, Virginia, 24016, United States
Winchester Neurological Consultants
Winchester, Virginia, 22601, United States
UW Medicine Valle Medical Center
Renton, Washington, 98055, United States
University of Washington School of Medicine, Regional Epilepsy Center at Harborview Medical Center
Seattle, Washington, 98104, United States
Children's and Women's Health Centre of British Columbia (BC Children's Hospital)
Vancouver, British Columbia, V6H 3V4, Canada
London Health Sciences Center
London, Ontario, N6A 5A5, Canada
University Health Network-Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
LLC Arensia Exploratory Medicine
Tbilisi, 0112, Georgia
Epilepsiezentrum Berlin-Brandenburg
Berlin, 10365, Germany
Bethel Epilepsy Centre
Bielefeld, 33617, Germany
Univ.-Klinik Bonn, Klinik und Poliklinik fur Epileptologie
Bonn, 53127, Germany
Universitatsklinikym Frankfurt
Frankfurt, 60528, Germany
Universitatsklinikum Freiburg, Neurozentrum/Epilepsiezentrum
Freiburg im Breisgau, 79106, Germany
University Hospital Munster (UKM)
Münster, 48149, Germany
Klinikum Osnabruck
Osnabrück, 49076, Germany
Krankenhaus Barmherzige Brueder Regensburg
Regensburg, 93049, Germany
University of Tubingen-Dept. of Neurology and Epileptology
Tübingen, 72076, Germany
IRCCS- Istituto delle Scienze Neurologiche, Bellaria Hospital
Bologna, 40139, Italy
Dipartimento Scienze Mediche e Chirurgiche, Universita Magna Graecia di Catanzaro
Catanzaro, 88100, Italy
Fondazione IRCCS Istituto Neurologico C. Besta
Milan, 20133, Italy
IRCCS Istituto Neurologico Nazionale C. Mondino
Pavia, 27100, Italy
Azienda Ospedaliera Universita' Pisana
Pisa, 56124, Italy
Azienda Ospedaliera "Bianchi-Melacrino-Morelle"di Reggio Calabria
Reggio Calabria, 89123, Italy
Policlinico di Roma Umberto I
Roma, 00185, Italy
PMSI Republican Clinical Hospital, ARENSIA Exploratory Medicine
Chisinau, 2025, Moldova
Hospital Virgen Macarena
Seville, Andalusia, 41009, Spain
Centro de Neurologia Avanzada
Seville, Andalusia, 41013, Spain
Hospital Germans Trias I Pujol
Badalona, Barcelona, 08916, Spain
Clínica Universidad Navarra
Pamplona, Navarre, 31008, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Universitario Vall d'Hebron
Barcelona, 08035, Spain
Hospital Vithas La Salud
Granada, 18008, Spain
Hospital U. Ramón y Cajal
Madrid, 28034, Spain
Hospital Ruber Internacional
Madrid, 28036, Spain
Hospital U. Clínico San Carlos
Madrid, 28040, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Regional Universitario de Málaga
Málaga, 29010, Spain
Hospital Universitario y Politécnico La Fe
Valencia, 46026, Spain
Hospital Clínico Universitario Valladolid
Valladolid, 47003, Spain
Medical Center of Limited Liability Company "Harmoniya Krasy"
Kyiv, 01135, Ukraine
Institute of Neurological Sciences
Glasgow, Scotland, G514TF, United Kingdom
University Hospital of Wales
Cardiff, Wales, CF14 4XW, United Kingdom
King's College Hospital NHS Foundation Trust
London, SE5 9RS, United Kingdom
St. George's University Hospitals NHS Foundation Trust
London, SW17 0QT, United Kingdom
Related Publications (1)
French JA, Porter RJ, Perucca E, Brodie MJ, Rogawski MA, Pimstone S, Aycardi E, Harden C, Qian J, Rosenblut CL, Kenney C, Beatch GN; X-TOLE Study Group. Efficacy and Safety of XEN1101, a Novel Potassium Channel Opener, in Adults With Focal Epilepsy: A Phase 2b Randomized Clinical Trial. JAMA Neurol. 2023 Nov 1;80(11):1145-1154. doi: 10.1001/jamaneurol.2023.3542.
PMID: 37812429RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Affairs
- Organization
- Xenon Pharmaceuticals Inc.
Study Officials
- STUDY DIRECTOR
Study Director
Xenon Pharmaceuticals Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2019
First Posted
January 8, 2019
Study Start
January 30, 2019
Primary Completion
September 2, 2021
Study Completion (Estimated)
October 1, 2028
Last Updated
September 24, 2024
Results First Posted
September 24, 2024
Record last verified: 2024-09