A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

November 18, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

February 28, 2026

Conditions
Focal Onset Seizures
Interventions
DRUG

XEN1101

XEN1101 Capsules

DRUG

Placebo

Placebo Capsules

Trial Locations (127)

1023

University of Auckland, Auckland

1060

INECO and Favoloro Fundation, Buenos Aires

1221

Hospital General de Agudos J.M. Ramos Mejia, Buenos Aires

2031

Prince of Wales Hospital, Sydney

2050

Royal Prince Alfred Hospital (RAPH), Camperdown

2145

Westmead Hospital, Westmead

2217

Southern Neurology, Sydney

2700

MHAT Puls AD, Blagoevgrad

3004

The Alfred Hospital (Alfred Health), Melbourne

3052

The Royal Melbourne Hospital, Melbourne

3065

St Vincent's Hospital Melbourne, Fitzroy

3079

Austin Health Pharmacy Clinical Trials, Heidelberg

3204

Waikato Hospital, Hamilton

4000

Sanatorio del Sur S.A., San Miguel de Tucumán

4101

The University of Queensland (UQ) - Mater Research Institute (MRI), Brisbane

10016

NYU Comprehensive Epilepsy Center (CEC), New York

10021

Weill Cornell Medicine/ New York-Presbyterian Hospital, New York

10029

Mount Sinai Medical Center, New York

13210

SUNY Upstate Medical University, Syracuse

14050

Human Science Research Trials S. de R.L. de C.V., Mexico City

14226

Dent Neurosciences Research Center, Buffalo

19107

Thomas Jefferson University, Philadelphia

20735

MedStar Health Research Institute, Clinton

20782

Medstar Health Research Institute, Hyattsville

20817

Mid-Atlantic Epilepsy and Sleep Center, Bethesda

21201

University of Maryland Medical Center, Baltimore

23456

Sentara Neurology Specialists, Virginia Beach

24013

Carilion Clinic - Neurology, Roanoke

27157

Wake Forest Baptist Health, Winston-Salem

27607

Meridian Clinical Research, LLC, Raleigh

27713

Duke Neurology, Durham

28034

Hospital Ramón y Cajal, Madrid

Hospital Ruber Internacional, Madrid

Hospital Vithas La Milagrosa, Madrid

28040

Hospital Clinico San Carlos, Madrid

IIS-Fundacion Jimenez Diaz/Farmacia, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28211

Onsite Clinical Solutions, LLC, Charlotte

29010

Hospital Regional De Malaga, Málaga

30329

Emory Brain Health Center, Atlanta

32503

Panhandle Research & Medical Clinic, Pensacola

32806

Research Institute of Orlando, LLC, Orlando

33021

Encore Medical Research of Weston, LLC, Weston

33134

Floridian Community Research Center, Coral Gables

33176

Serenity Research, Miami

33606

University of South Florida, Tampa

33617

Epilepsy Center Bethel, Bielefeld

33952

Medsol Clinical Research Center, Port Charlotte

35043

Philipps-Universität Marburg, Marburg

36604

Strada Patient Care Center, Mobile

40139

Istituto delle Scienze Neurologiche di Bologna, Bologna

40504

Bluegrass Epilepsy Research, LLC, Lexington

44304

Summa Health, Akron

46026

Hospital Universitario y Politecnico La Fe, Valencia

46202

Indiana University, IU Health Partners, Adult Neurology Clinic, Indianapolis

47003

Hospital Clínico Universitario Valladolid, Valladolid

48109

University of Michigan, Ann Arbor

48824

Michigan State University, East Lansing

49506

Cornwell Health, Grand Rapids

53215

Aurora St. Luke's Medical Center, Milwaukee

55337

Minneapolis Clinic of Neurology, Burnsville

56100

Azienda Ospedaliero Universitaria Pisana, Pisa

60528

Epilepsiezentrum Frankfurt Rhein-Main, Frankfurt

63104

Saint Louis University Medical School - Neurosciences Clinical Research Unit, St Louis

63110

Washington University, St. Louis, St Louis

66100

Università Degli Studi Gabriele d'Annunzio Di Chieti, Pescara

66160

The University of Kansas Medical Center, Kansas City

72076

Universitätsklinikum Tübingen, Tübingen

72205

Clinical Trials, Inc, Little Rock

77030

UT Physicians Epilepsy Clinic, Houston

78229

UT Health San Antonio, San Antonio

78758

Austin Epilepsy Care Center (AECC), Austin

79106

University Medical Center Freiburg, Freiburg im Breisgau

79912

ANESC Research, El Paso

80011

Anschutz Health Sciences, Aurora

80020

Neurocencias Esudios Clinicos SC, Sinaloa

81277

LMU Munich, Department of Neurology, Munich

83702

Consultants in Epilepsy and Neurology, Boise

85004

Xenoscience, Phoenix

85724

University of Arizona, Health Sciences Center, Tucson

89081

Universitatsklinik fur neurologie, universitats - und Rehabilitationskliniken Ulm, Ulm

90025

Brain Science Research Institute, Los Angeles

95817

University of California, David Clinical & Translational Science Center Clinical Research (CCRC), Sacramento

96817

Hawaii Pacific Neuroscience, Honolulu

97225

Providence Brain & Spine Institute, Portland

98104

University of Washington Main Hospital, Seattle

833073

Centro de investigación Clinica UC, Santiago

2520612

Hospital Clínico Vina del Mar, Viña del Mar

40536-0284

University of Kentucky, Dept. of Neurology, Lexington

04074

MaineHealth Neurology - Scarborough, Scarborough

02115

Brigham and Women's Hospital, Boston

01655

UMass Memorial Medical Center, Worcester

07601

Northeast Epilepsy Group, Hackensack

10467-2401

Montefiore Medical Center, The Bronx

19140-4105

Temple University Hospital, Philadelphia

B1888AAE

Hospital De Alta Complejidad en Red el Cruce Nestor Kirchner - SAMIC, Buenos Aires

C1023AAB

STAT Research S.A., Buenos Aires

C1199ABB

Hospital Italiano, Buenos Aires

C1424

CENyR, Caba

CP 5000

Hospital Córdoba, Córdoba

T1J 0N9

Center For Neurologic Research, Lethbridge

N6A 5A5

London Health Sciences Centre, London

H2X3E4

Le Centre Hospitalier de l'Universite' de Montreal (CHUM), Montreal

160-00

FORBELI s.r.o., Neurologicka ambulance, Prague

0121

American Hospital Network LLC, Tbilisi

0186

Institute of Neurology and Neuropsychology, Tbilisi

Unknown

Universitatsklinikum Bonn, Bonn

D09 YD60

Beaumont Hospital, Dublin

00165

Ospedale Pediatrico Bambino Gesu, Roma

00186

Azienda Ospedaliero-Universitaria Policlinico Umberto I, Rome

LV-1002

Pauls Stradina Clinical university hospital, Riga

LV-1024

Riga East University Hospital, Riga

85-163

Centrum Medyczne Neuromed, Bydgoszcz

40-650

NZOZ Novo-Med, Katowice

67-100

Twoja Przychodnia NCM, Nowa Sól

02-829

Neurosphera Sp. z o.o., Warsaw

4200-450

Unidade Local de Saúde de São João, Porto

4464-513

Hospital Pedro Hispano, Porto

4520-220

Centro Hospitalar de Entre o Douro e Vouga, Santa Maria da Feira

08036

Unitat d'Assaigs Clínics. Servei de Farmàcia, Barcelona

B152GW

University Hospitals Birmingham NHS Foundation Trust, Birmingham

CF144XW

University Hospital of Wales, Cardiff

LS1 3EX

Leeds Teaching Hospitals NHS Trust, Leeds

SW17 0QT

St. George's Hospital NHS Foundation Trust, London

WC1N 3HR

Royal London Hospital for Integrated Medicine, London

OX3 9DU

John Radcliffe Hospital, Oxford

M6 8HD

Northern Care Alliance NHS Foundation Trust, Salford Care Organisation, Salford

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Worldwide Clinical Trials

OTHER

lead

Xenon Pharmaceuticals Inc.

INDUSTRY