A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)

April 18, 2024 updated by: Xenon Pharmaceuticals Inc.

A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures

The X-TOLE3 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Approximately 360 subjects will be randomized in a blinded manner to one of two active treatment groups or placebo in a 1:1:1 fashion (XEN1101 25 mg : 15 mg : Placebo). Eligible subjects will have up to 9.5 weeks of baseline to assess frequency of seizures, followed by 12 weeks of blinded treatment. In order to be included in the study, subjects must be treated with a stable dose of 1 to 3 allowable antiseizure medications (ASMs) for at least one month prior to screening, during baseline, and throughout the double-blind treatment period (DBP) of the study. During the DBP, subjects will be instructed to orally take XEN1101 or placebo once daily with an evening meal.

Subjects who complete the 12-week DBP will have the opportunity to qualify and enroll in a separate open-label extension (OLE) study for continued treatment with XEN1101. Subjects who do not enroll in the OLE will enter a 8-week post treatment follow-up period.

Study Type

Interventional

Enrollment (Estimated)

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Recruiting
        • STAT Resarch S.A.
  • Austria
      • Innsbruck, Austria
        • Recruiting
        • University Hospital Innsbruck
  • Chile
      • Santiago, Chile, 7620157
        • Recruiting
        • Clínica Universidad de los Andes
      • Santiago, Chile, 833073
        • Recruiting
        • Centro de Investigacion Clinica UC
      • Viña Del Mar, Chile
        • Recruiting
        • Hospital Clinico Vina del Mar
  • Croatia
      • Osijek, Croatia, 31000
        • Recruiting
        • University Hospital Center Osijek
      • Zagreb, Croatia, 10000
        • Recruiting
        • University Hospital Center Zagreb
      • Zagreb, Croatia, 10000
        • Recruiting
        • Poliklinika Bonifarm
  • Czechia
      • Hradec Králové, Czechia
        • Recruiting
        • EUC Hradec Kralove Clinic
      • Prague, Czechia, 150 06
        • Recruiting
        • Nemocnicni lekarna FN Motol / Motol University Hospital
      • Prague, Czechia
        • Recruiting
        • FORBELI s.r.o.
  • Italy
      • Ancona, Italy, 60126
        • Recruiting
        • Ospedali Riuniti di Ancona
  • Poland
      • Gdańsk, Poland
        • Recruiting
        • COPERNICUS Podmiot Leczniczy
      • Lublin, Poland, 20-064
        • Recruiting
        • NZOZ Neuromed M. i M. Nastaj Sp. P.
      • Nowa Sól, Poland, 67-100
        • Recruiting
        • Twoja Przychodnia Nowosolskie Centrum Medyczne
      • Warsaw, Poland, 02-172
        • Recruiting
        • MTZ Clinical Research Powered by Pratia
  • Portugal
      • Coimbra, Portugal
        • Recruiting
        • Centro Hospitalar Universitário de Coimbra - CHUC
      • Guimarães, Portugal, 4835-044
        • Recruiting
        • Hospital da Senhora da Oliveira
      • Lisbon, Portugal
        • Recruiting
        • Centro Hospitalar Lisboa Ocidental
      • Lisbon, Portugal, 1649-035
        • Recruiting
        • Centro Hospitalar de Lisboa Norte
      • Porto, Portugal, 4099-001
        • Recruiting
        • Centro Hospitalar Universitario de Santo Antonio
      • Porto, Portugal, 4464-513
        • Recruiting
        • Hospital Pedro Hispano
      • Santa Maria Da Feira, Portugal, 520-211
        • Recruiting
        • Centro Hospitalar de Entre o Douro e Vouga
  • Spain
      • Barakaldo, Spain, 48903
        • Recruiting
        • Hospital Universitario Cruces
  • United States
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • University of California Irvine Health
    • Illinois
      • Springfield, Illinois, United States, 62794
        • Recruiting
        • Southern Illinois University School of Medicine
    • New York
      • Woodmere, New York, United States, 11598
        • Recruiting
        • Five Towns Neuroscience Research
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah Clinical Neurosciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study
  • Diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy (2017). Subject must have had adequate trials of at least 2 ASMs, which were given (and tolerated) at adequate therapeutic doses, without achieving sustained seizure freedom.
  • Treatment with a stable dose of 1 to 3 allowable current ASMs for at least one month prior to screening, during baseline, and throughout the duration of the DBP
  • Able to keep accurate seizure diaries

Exclusion Criteria:

  • Previously documented electroencephalogram which shows any pattern not consistent with focal etiology of seizures.
  • History of focal aware non-motor seizures only, non-epileptic psychogenic seizure, primary generalized seizure, developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome.
  • Seizures secondary to drug or alcohol use, ongoing infection, neoplasia, demyelinating disease, degenerative neurological disease, metabolic illness, progressive structural lesion, encephalopathy, or progressive central nervous system (CNS) disease.
  • History of status epilepticus or repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted.
  • History of neurosurgery for seizures <1 year prior to Visit 1, or radiosurgery <2 years prior to enrollment.
  • Any medical condition or personal circumstance that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study or prevents adherence to the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo Capsules
Experimental: XEN1101 25 mg/day
Drug: XEN1101
XEN1101 Capsules
Experimental: XEN1101 15 mg/day
Drug: XEN1101
XEN1101 Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Median percent change (MPC) in focal seizure frequency from baseline to DBP for XEN1101 versus placebo.
Time Frame: From baseline through to the double blind period (week 12).
From baseline through to the double blind period (week 12).

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects experiencing ≥50% reduction in focal seizure frequency from baseline through the DBP for XEN1101 versus placebo.
Time Frame: From baseline through to the double blind period (week 12).
From baseline through to the double blind period (week 12).
MPC in weekly (7 days) focal seizure frequency from baseline to Week 1 for XEN1101 versus placebo.
Time Frame: From baseline through to the week 1.
From baseline through to the week 1.
Proportion of subjects experiencing "at least much improved" (including "much" and "very much improved") in Patient Global Impression of Change (PGI-C).
Time Frame: From baseline through to the double blind period (week 12).
From baseline through to the double blind period (week 12).
To assess adverse events as criteria for safety and tolerability of XEN1101.
Time Frame: From screening through to 56 days post-final dose
From screening through to 56 days post-final dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xenon Pharmaceuticals Inc.

Collaborators

Worldwide Clinical Trials

Investigators

  • Study Director: Xenon Medical Director, Xenon Pharmaceuticals Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2023

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 26, 2023

First Submitted That Met QC Criteria

February 6, 2023

First Posted (Actual)

February 8, 2023

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XPF-010-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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