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A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy (X-TOLE)

Primary Purpose

Focal Epilepsy

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
XEN1101
Sponsored by
Xenon Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Focal Epilepsy focused on measuring Epilepsy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Strada Patient Care Center
  • Xenoscience, Inc.
  • Clinical Trials, Inc.
  • Altman Clinical Translational Research Institute (ACTRI)
  • California Pacific Medical Center (CPMC) - Sutter Pacific Epilepsy Program
  • University of Colorado Hospital Anschutz Outpatient Pavilion
  • University of Florida Jacksonville
  • Mayo Clinic Florida
  • Visionary Investigators Network
  • Don Clinical Research Center
  • The Neurology Research Group, LLC.
  • Research Institute of Orlando, LLC
  • Medsol Clinical Research Center
  • Tallahassee Neurological Clinic
  • University of South Florida
  • Georgia Neurology and Sleep Medicine Associate
  • Hawaii Pacific Neuroscience
  • Consultants in Epilepsy and Neurology, PLLC
  • Northwestern Medical Group, Department of Neurology
  • University of Kansas Medical Center
  • Bluegrass Epilepsy Research
  • Maine Medical Partners Neurology
  • Mid-Atlantic Epilepsy and Sleep Center
  • Boston Neuro Research Center
  • Minneapolis Clinic of Neurology, Ltd.
  • Minnesota Epilepsy Group, P. A.
  • Northeast Regional Epilepsy Group
  • Institute of Neurology and Neurosurgery at Saint Barnabas
  • Northeast Regional Epilepsy Group
  • Dent Neurosciences Research Center
  • NYU Langone Medical Center/NYU School of Medicine
  • Northwell Health - Lenox Hill
  • SUNY Upstate Medical University Institute for Human Performance
  • Five Towns Neuroscience Research
  • Asheville Neurology Specialists, PA
  • UC Gardner Neuroscience Institute
  • Miami Valley Hospital
  • University of Toledo Medical Center
  • Providence Neurological Specialties East
  • Hospital of the University of Pennsylvania
  • Thomas Jefferson University Comprehensive Epilepsy Center
  • Allegheny Neurological Associates
  • Vanderbilt Epilepsy Clinic
  • Austin Epilepsy Care Center
  • James W. Aston Ambulatory Care Center
  • The University of Texas Health Science Center at San Antonio
  • University of Utah Health Clinical Neurosciences Center
  • University of Virginia
  • Virginia Commonwealth University
  • Carilion Neurology Clinic
  • Winchester Neurological Consultants
  • UW Medicine Valle Medical Center
  • University of Washington School of Medicine, Regional Epilepsy Center at Harborview Medical Center
  • Children's and Women's Health Centre of British Columbia (BC Children's Hospital)
  • London Health Sciences Center
  • University Health Network-Toronto Western Hospital
  • LLC Arensia Exploratory Medicine
  • Epilepsiezentrum Berlin-Brandenburg
  • Bethel Epilepsy Centre
  • Univ.-Klinik Bonn, Klinik und Poliklinik fur Epileptologie
  • Universitatsklinikym Frankfurt
  • Universitatsklinikum Freiburg, Neurozentrum/Epilepsiezentrum
  • University Hospital Munster (UKM)
  • Klinikum Osnabruck
  • Krankenhaus Barmherzige Brueder Regensburg
  • University of Tubingen-Dept. of Neurology and Epileptology
  • IRCCS- Istituto delle Scienze Neurologiche, Bellaria Hospital
  • Dipartimento Scienze Mediche e Chirurgiche, Universita Magna Graecia di Catanzaro
  • Fondazione IRCCS Istituto Neurologico C. Besta
  • IRCCS Istituto Neurologico Nazionale C. Mondino
  • Azienda Ospedaliera Universita' Pisana
  • Azienda Ospedaliera "Bianchi-Melacrino-Morelle"di Reggio Calabria
  • Policlinico di Roma Umberto I
  • PMSI Republican Clinical Hospital, ARENSIA Exploratory Medicine
  • Hospital Virgen Macarena
  • Centro de Neurologia Avanzada
  • Hospital Germans Trias I Pujol
  • Clínica Universidad Navarra
  • Hospital del Mar
  • Hospital Universitario Vall d'Hebron
  • Hospital Vithas La Salud
  • Hospital U. Ramón y Cajal
  • Hospital Ruber Internacional
  • Hospital U. Clínico San Carlos
  • Hospital Universitario Fundacion Jimenez Diaz
  • Hospital Universitario 12 de Octubre
  • Hospital Regional Universitario de Málaga
  • Hospital Universitario y Politécnico La Fe
  • Hospital Clínico Universitario Valladolid
  • Medical Center of Limited Liability Company "Harmoniya Krasy"
  • Institute of Neurological Sciences
  • University Hospital of Wales
  • King's College Hospital NHS Foundation Trust
  • St. George's University Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

25 mg XEN1101

20 mg XEN1101

10 mg XEN1101

Placebo

Arm Description

Capsule filled with 25 mg XEN1101

Capsule filled with 20 mg XEN1101

Capsule filled with 10 mg XEN1101

Placebo capsule

Outcomes

Primary Outcome Measures

To assess the efficacy of XEN1101 compared to placebo on focal seizure frequency (e.g., median percent change in focal seizure frequency) in adults with focal epilepsy taking 1-3 antiepileptic drugs (AEDs) in the double-blind treatment period (DBP)
Median percent change in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo
To assess the safety and tolerability of XEN1101 (e.g., adverse events) in adults with focal epilepsy taking 1-3 AEDs
To assess adverse events as criteria for safety and tolerability

Secondary Outcome Measures

To evaluate the 50% XEN1101 response rates in comparison to placebo in the DBP
Responders are defined as patients experiencing ≥50% reduction in monthly (28 days) focal seizure frequency from baseline to DBP
To evaluate trends in focal seizure frequency over time in the DBP
Percent change from baseline in weekly focal seizure frequency for each week in the DBP

Full Information

First Posted
January 2, 2019
Last Updated
January 12, 2023
Sponsor
Xenon Pharmaceuticals Inc.
Collaborators
Novotech Health Holdings Pte. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03796962
Brief Title
A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
Acronym
X-TOLE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 30, 2019 (Actual)
Primary Completion Date
September 2, 2021 (Actual)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xenon Pharmaceuticals Inc.
Collaborators
Novotech Health Holdings Pte. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
The XEN1101 Phase 2 clinical trial is designed as a randomized, double-blind, placebo-controlled, multicenter study with an optional open-label extension (OLE) to evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive treatment in adult patients aged 18 to 75 years diagnosed with focal epilepsy. Approximately 300 patients will be randomized in a blinded manner to one of three active treatment groups or placebo in a 2:1:1:2 fashion (XEN1101 25 mg : 20 mg : 10 mg : Placebo). After screening, patients will have 8 weeks of baseline to assess frequency of seizures, followed by 8 weeks of treatment and a 6-week post treatment follow-up period. In order to be included in the study, patients must already be treated with a stable dose of 1 to 3 allowable current anti-epileptic drugs for at least one month prior to screening, during baseline, and throughout the double-blind portion (DBP) of the study. During the treatment period, patients will be given XEN1101 or placebo once daily in the evening. A five year OLE will be available to eligible patients who complete the DBP. All patients will receive a 20 mg daily dose of XEN1101 during this extension period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focal Epilepsy
Keywords
Epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
325 (Actual)

8. Arms, Groups, and Interventions

Arm Title
25 mg XEN1101
Arm Type
Experimental
Arm Description
Capsule filled with 25 mg XEN1101
Arm Title
20 mg XEN1101
Arm Type
Experimental
Arm Description
Capsule filled with 20 mg XEN1101
Arm Title
10 mg XEN1101
Arm Type
Experimental
Arm Description
Capsule filled with 10 mg XEN1101
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule
Intervention Type
Drug
Intervention Name(s)
XEN1101
Intervention Description
Oral dose
Primary Outcome Measure Information:
Title
To assess the efficacy of XEN1101 compared to placebo on focal seizure frequency (e.g., median percent change in focal seizure frequency) in adults with focal epilepsy taking 1-3 antiepileptic drugs (AEDs) in the double-blind treatment period (DBP)
Description
Median percent change in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo
Time Frame
From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56)
Title
To assess the safety and tolerability of XEN1101 (e.g., adverse events) in adults with focal epilepsy taking 1-3 AEDs
Description
To assess adverse events as criteria for safety and tolerability
Time Frame
From screening (up to 28 days prior to baseline) through to 42 days post-final dose
Secondary Outcome Measure Information:
Title
To evaluate the 50% XEN1101 response rates in comparison to placebo in the DBP
Description
Responders are defined as patients experiencing ≥50% reduction in monthly (28 days) focal seizure frequency from baseline to DBP
Time Frame
From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56)
Title
To evaluate trends in focal seizure frequency over time in the DBP
Description
Percent change from baseline in weekly focal seizure frequency for each week in the DBP
Time Frame
From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Xenon Pharmaceuticals Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Strada Patient Care Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Xenoscience, Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Clinical Trials, Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Altman Clinical Translational Research Institute (ACTRI)
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
California Pacific Medical Center (CPMC) - Sutter Pacific Epilepsy Program
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
University of Colorado Hospital Anschutz Outpatient Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Florida Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Visionary Investigators Network
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Don Clinical Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
The Neurology Research Group, LLC.
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Research Institute of Orlando, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Medsol Clinical Research Center
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Tallahassee Neurological Clinic
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Georgia Neurology and Sleep Medicine Associate
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
Hawaii Pacific Neuroscience
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Consultants in Epilepsy and Neurology, PLLC
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Northwestern Medical Group, Department of Neurology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Bluegrass Epilepsy Research
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Maine Medical Partners Neurology
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Mid-Atlantic Epilepsy and Sleep Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Boston Neuro Research Center
City
South Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Minneapolis Clinic of Neurology, Ltd.
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Minnesota Epilepsy Group, P. A.
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Northeast Regional Epilepsy Group
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Institute of Neurology and Neurosurgery at Saint Barnabas
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Northeast Regional Epilepsy Group
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Dent Neurosciences Research Center
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
NYU Langone Medical Center/NYU School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Northwell Health - Lenox Hill
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
SUNY Upstate Medical University Institute for Human Performance
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Five Towns Neuroscience Research
City
Woodmere
State/Province
New York
ZIP/Postal Code
11598
Country
United States
Facility Name
Asheville Neurology Specialists, PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28806
Country
United States
Facility Name
UC Gardner Neuroscience Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
University of Toledo Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Providence Neurological Specialties East
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University Comprehensive Epilepsy Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Allegheny Neurological Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Vanderbilt Epilepsy Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Austin Epilepsy Care Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
James W. Aston Ambulatory Care Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
The University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
Facility Name
University of Utah Health Clinical Neurosciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Carilion Neurology Clinic
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Facility Name
Winchester Neurological Consultants
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
UW Medicine Valle Medical Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
Facility Name
University of Washington School of Medicine, Regional Epilepsy Center at Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Children's and Women's Health Centre of British Columbia (BC Children's Hospital)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Name
London Health Sciences Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
University Health Network-Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
LLC Arensia Exploratory Medicine
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
Epilepsiezentrum Berlin-Brandenburg
City
Berlin
ZIP/Postal Code
10365
Country
Germany
Facility Name
Bethel Epilepsy Centre
City
Bielefeld
ZIP/Postal Code
33617
Country
Germany
Facility Name
Univ.-Klinik Bonn, Klinik und Poliklinik fur Epileptologie
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Universitatsklinikym Frankfurt
City
Frankfurt
ZIP/Postal Code
60528
Country
Germany
Facility Name
Universitatsklinikum Freiburg, Neurozentrum/Epilepsiezentrum
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
University Hospital Munster (UKM)
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Klinikum Osnabruck
City
Osnabrück
ZIP/Postal Code
49076
Country
Germany
Facility Name
Krankenhaus Barmherzige Brueder Regensburg
City
Regensburg
ZIP/Postal Code
93049
Country
Germany
Facility Name
University of Tubingen-Dept. of Neurology and Epileptology
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
IRCCS- Istituto delle Scienze Neurologiche, Bellaria Hospital
City
Bologna
ZIP/Postal Code
40139
Country
Italy
Facility Name
Dipartimento Scienze Mediche e Chirurgiche, Universita Magna Graecia di Catanzaro
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Fondazione IRCCS Istituto Neurologico C. Besta
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
IRCCS Istituto Neurologico Nazionale C. Mondino
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliera Universita' Pisana
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Azienda Ospedaliera "Bianchi-Melacrino-Morelle"di Reggio Calabria
City
Reggio Calabria
ZIP/Postal Code
89123
Country
Italy
Facility Name
Policlinico di Roma Umberto I
City
Roma
ZIP/Postal Code
00185
Country
Italy
Facility Name
PMSI Republican Clinical Hospital, ARENSIA Exploratory Medicine
City
Chisinau
ZIP/Postal Code
2025
Country
Moldova, Republic of
Facility Name
Hospital Virgen Macarena
City
Sevilla
State/Province
Andalusia
ZIP/Postal Code
41009
Country
Spain
Facility Name
Centro de Neurologia Avanzada
City
Sevilla
State/Province
Andalusia
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Germans Trias I Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Clínica Universidad Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Vithas La Salud
City
Granada
ZIP/Postal Code
18008
Country
Spain
Facility Name
Hospital U. Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Ruber Internacional
City
Madrid
ZIP/Postal Code
28036
Country
Spain
Facility Name
Hospital U. Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Regional Universitario de Málaga
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario y Politécnico La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Clínico Universitario Valladolid
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Facility Name
Medical Center of Limited Liability Company "Harmoniya Krasy"
City
Kyiv
ZIP/Postal Code
01135
Country
Ukraine
Facility Name
Institute of Neurological Sciences
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G514TF
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
St. George's University Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy

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