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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Key Inclusion Criteria:
* 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
Key Exclusion Criteria:
* 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:
1. History of presence of long QT syndrome; QTcF \> 450 msec at baseline; family history of sudden death of unknown cause
2. 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
Primary outcome measure(s)
Median Percent Change in Focal Seizure Frequency — From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56) Median percent change in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo
Trial sites (95)
Facility
City
Region
Status
University of Alabama at Birmingham
Birmingham
Alabama
Strada Patient Care Center
Mobile
Alabama
Xenoscience, Inc.
Phoenix
Arizona
Clinical Trials, Inc.
Little Rock
Arkansas
Altman Clinical Translational Research Institute (ACTRI)
La Jolla
California
California Pacific Medical Center (CPMC) - Sutter Pacific Epilepsy Program
San Francisco
California
University of Colorado Hospital Anschutz Outpatient Pavilion
Aurora
Colorado
University of Florida Jacksonville
Jacksonville
Florida
Mayo Clinic Florida
Jacksonville
Florida
Visionary Investigators Network
Miami
Florida
Don Clinical Research Center
Miami
Florida
The Neurology Research Group, LLC.
Miami
Florida
Research Institute of Orlando, LLC
Orlando
Florida
Medsol Clinical Research Center
Port Charlotte
Florida
Tallahassee Neurological Clinic
Tallahassee
Florida
University of South Florida
Tampa
Florida
Georgia Neurology and Sleep Medicine Associate
Suwanee
Georgia
Hawaii Pacific Neuroscience
Honolulu
Hawaii
Consultants in Epilepsy and Neurology, PLLC
Boise
Idaho
Northwestern Medical Group, Department of Neurology
Chicago
Illinois
University of Kansas Medical Center
Kansas City
Kansas
Bluegrass Epilepsy Research
Lexington
Kentucky
Maine Medical Partners Neurology
Scarborough
Maine
Mid-Atlantic Epilepsy and Sleep Center
Bethesda
Maryland
Boston Neuro Research Center
South Dartmouth
Massachusetts
Minneapolis Clinic of Neurology, Ltd.
Golden Valley
Minnesota
Minnesota Epilepsy Group, P. A.
Saint Paul
Minnesota
Northeast Regional Epilepsy Group
Hackensack
New Jersey
Institute of Neurology and Neurosurgery at Saint Barnabas
Livingston
New Jersey
Northeast Regional Epilepsy Group
Morristown
New Jersey
Dent Neurosciences Research Center
Amherst
New York
NYU Langone Medical Center/NYU School of Medicine
New York
New York
Northwell Health - Lenox Hill
New York
New York
SUNY Upstate Medical University Institute for Human Performance
Syracuse
New York
Five Towns Neuroscience Research
Woodmere
New York
Asheville Neurology Specialists, PA
Asheville
North Carolina
UC Gardner Neuroscience Institute
Cincinnati
Ohio
Miami Valley Hospital
Dayton
Ohio
University of Toledo Medical Center
Toledo
Ohio
Providence Neurological Specialties East
Portland
Oregon
+ 55 more sites — see the full list on the official registry below.
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.
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