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

Primary Purpose

Focal Onset Seizures

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
XEN1101
Placebo
Sponsored by
Xenon Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

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.

Sites / Locations

  • University of California Irvine HealthRecruiting
  • Southern Illinois University School of MedicineRecruiting
  • Five Towns Neuroscience ResearchRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • University of Utah Clinical Neurosciences CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

XEN1101 25 mg/day

XEN1101 15 mg/day

Placebo

Arm Description

XEN1101 25 mg/day

XEN1101 15 mg/day

Placebo

Outcomes

Primary Outcome Measures

Median percent change (MPC) in focal seizure frequency from baseline to DBP for XEN1101 versus placebo.

Secondary Outcome Measures

Proportion of subjects experiencing ≥50% reduction in focal seizure frequency from baseline through the DBP for XEN1101 versus placebo.
MPC in weekly (7 days) focal seizure frequency from baseline to Week 1 for XEN1101 versus placebo.
Proportion of subjects experiencing "at least much improved" (including "much" and "very much improved") in Patient Global Impression of Change (PGI-C).
To assess adverse events as criteria for safety and tolerability of XEN1101.

Full Information

First Posted
January 26, 2023
Last Updated
September 7, 2023
Sponsor
Xenon Pharmaceuticals Inc.
Collaborators
Worldwide Clinical Trials
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1. Study Identification

Unique Protocol Identification Number
NCT05716100
Brief Title
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2023 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xenon Pharmaceuticals Inc.
Collaborators
Worldwide Clinical Trials

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
XEN1101 25 mg/day
Arm Type
Experimental
Arm Description
XEN1101 25 mg/day
Arm Title
XEN1101 15 mg/day
Arm Type
Experimental
Arm Description
XEN1101 15 mg/day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
XEN1101
Intervention Description
XEN1101 Capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Capsules
Primary Outcome Measure Information:
Title
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).
Secondary Outcome Measure Information:
Title
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).
Title
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.
Title
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).
Title
To assess adverse events as criteria for safety and tolerability of XEN1101.
Time Frame
From screening through to 56 days post-final dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xenon Medical Affairs
Phone
1-604-484-3300
Email
XenonCares@xenon-pharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xenon Medical Director
Organizational Affiliation
Xenon Pharmaceuticals Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of California Irvine Health
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794
Country
United States
Individual Site Status
Recruiting
Facility Name
Five Towns Neuroscience Research
City
Woodmere
State/Province
New York
ZIP/Postal Code
11598
Country
United States
Individual Site Status
Recruiting
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Utah Clinical Neurosciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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