Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05614063




Registration number
NCT05614063
Ethics application status
Date submitted
6/11/2022
Date registered
14/11/2022
Date last updated
14/05/2024

Titles & IDs
Public title
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures
Scientific 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
Secondary ID [1] 0 0
2022-502000-73-00
Secondary ID [2] 0 0
XPF-010-301
Universal Trial Number (UTN)
Trial acronym
X-TOLE2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Focal Onset Seizures 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - XEN1101
Treatment: Drugs - Placebo

Experimental: XEN1101 25 mg/day - XEN1101 25 mg/day

Experimental: XEN1101 15 mg/day - XEN1101 15 mg/day

Placebo Comparator: Placebo - Placebo


Treatment: Drugs: XEN1101
XEN1101 Capsules

Treatment: Drugs: Placebo
Placebo Capsules
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Median percent change (MPC) in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo.
Timepoint [1] 0 0
From baseline through to the double blind period (week 12)
Secondary outcome [1] 0 0
Proportion of subjects experiencing =50% reduction in monthly (28 days) focal seizure frequency from baseline through the DBP for XEN1101 versus placebo.
Timepoint [1] 0 0
From baseline through to the double blind period (week 12)
Secondary outcome [2] 0 0
MPC in weekly (7 days) focal seizure frequency from baseline to Week 1 for XEN1101 versus placebo.
Timepoint [2] 0 0
From baseline through to the week 1
Secondary outcome [3] 0 0
Proportion of subjects experiencing "at least much improved" (including "much" and "very much improved") in Patient Global Impression of Change (PGI-C).
Timepoint [3] 0 0
From baseline through to the double blind period (week 12)
Secondary outcome [4] 0 0
To assess adverse events as criteria for safety and tolerability of XEN1101
Timepoint [4] 0 0
From screening through to 56 days post-final dose.

Eligibility
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

- 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
MelbourneNSW,QLD,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital (RAPH) - Camperdown
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
The University of Queensland (UQ) - Brisbane
Recruitment hospital [5] 0 0
Austin Health Pharmacy Clinical Trials - Heidelberg
Recruitment hospital [6] 0 0
Southern Neurology - Kogarah
Recruitment hospital [7] 0 0
Alfred Health - Melbourne
Recruitment hospital [8] 0 0
The Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4101 - Brisbane
Recruitment postcode(s) [5] 0 0
3079 - Heidelberg
Recruitment postcode(s) [6] 0 0
2217 - Kogarah
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
3052 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Hawaii
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United States of America
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Idaho
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kentucky
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United States of America
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Maine
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United States of America
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Maryland
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United States of America
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Massachusetts
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Michigan
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Minnesota
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Missouri
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New Jersey
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Texas
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Virginia
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Washington
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United States of America
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Wisconsin
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Bulgaria
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Blagoevgrad
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Bulgaria
State/province [30] 0 0
Sofia
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Canada
State/province [31] 0 0
Alberta
Country [32] 0 0
Canada
State/province [32] 0 0
Ontario
Country [33] 0 0
Canada
State/province [33] 0 0
Quebec
Country [34] 0 0
Italy
State/province [34] 0 0
Bologna
Country [35] 0 0
Italy
State/province [35] 0 0
Pisa
Country [36] 0 0
Italy
State/province [36] 0 0
Rome
Country [37] 0 0
Poland
State/province [37] 0 0
Bydgoszcz
Country [38] 0 0
Poland
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Katowice
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Poland
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Lublin
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Málaga
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Spain
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Valencia
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Spain
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Valladolid
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United Kingdom
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Birmingham
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United Kingdom
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Cardiff
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United Kingdom
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Dundee
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United Kingdom
State/province [48] 0 0
Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Xenon Pharmaceuticals Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Worldwide Clinical Trials
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The X-TOLE2 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05614063
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Xenon Pharmaceuticals Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Xenon Medical Affairs
Address 0 0
Country 0 0
Phone 0 0
1-604-484-3300
Fax 0 0
Email 0 0
XenonCares@xenon-pharma.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05614063