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Clinical Trials in Germany / NCT03796962
Active, not recruiting Phase 2

A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy

NCT03796962 · tracked via the Priya Life Science Germany tracker
Phase
Phase 2
Started
2019-01-30
Last updated
2024-09-24

Condition(s) studied

Focal Epilepsy

Investigational drug(s) / intervention(s)

XEN1101 →

XEN1101: Oral dose

Study 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).

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)

Trial sites (95)

FacilityCityRegionStatus
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.

More Xenon Pharmaceuticals Inc. trials in Germany

Other trials for the same condition

Official registry record

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.

View NCT03796962 on ClinicalTrials.gov ↗ ← All trials in Germany