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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05718817




Registration number
NCT05718817
Ethics application status
Date submitted
13/01/2023
Date registered
8/02/2023
Date last updated
27/12/2024

Titles & IDs
Public title
An Open-label Study of XEN1101 in Epilepsy
Scientific title
A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of XEN1101 in Subjects Diagnosed with Epilepsy
Secondary ID [1] 0 0
XPF-010-304
Universal Trial Number (UTN)
Trial acronym
X-TOLE4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Focal Epilepsy 0 0
Tonic-Clonic 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

Experimental: XEN1101 15 or 25 mg/day - XEN1101 15 or 25 mg/day


Treatment: Drugs: XEN1101
XEN1101 capsules
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The adverse events
Timepoint [1] 0 0
From the start of treatment in the OLE study through 8 weeks after the last dose.
Secondary outcome [1] 0 0
Change in monthly seizure rate
Timepoint [1] 0 0
From baseline through the active extension treatment (Week 156).
Secondary outcome [2] 0 0
Proportion of responders
Timepoint [2] 0 0
From baseline through the active extension treatment (Week 156).
Secondary outcome [3] 0 0
Change in Clinical Global Impression of Severity (CGI-S)
Timepoint [3] 0 0
From baseline through the active extension treatment (Week 156).
Secondary outcome [4] 0 0
Change in Patient Global Impression of Severity (PGI-S)
Timepoint [4] 0 0
From baseline through the active extension treatment (Week 156).
Secondary outcome [5] 0 0
Change in Quality of Life in Epilepsy Inventory (QOLIE-31)
Timepoint [5] 0 0
From baseline through the active extension treatment (Week 156).

Eligibility
Key inclusion criteria
1. Subject must be properly informed of the nature and risks of the study and give informed consent in writing prior to entering the study (for adult subjects) and for adolescent subject's parent/legal guardian and subject gives informed consent or assent in writing prior to entering the study.
2. Subject must have successfully completed the DBP and have not terminated early from Study X-TOLE2, X-TOLE3, or X-ACKT, met all eligibility requirements, and had no important protocol deviations (in the opinion of the sponsor) or AEs (in the opinion of the investigator) that would preclude the subject's entry into the long-term extension study.
3. In the opinion of the investigator, the subject is able to understand verbal and written instructions and will adhere to all study schedules and requirements.
4. Subject is able to keep accurate seizure diaries.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject met any of the withdrawal criteria while in Study X-TOLE2, X-TOLE3, or X-ACKT.
2. Subject has any medical condition, personal circumstance, or ongoing AE (from Study X-TOLE2, X-TOLE3, or X-ACKT) that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study, or prevents adherence to the protocol.
3. Subject is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for treatment of epilepsy or any other medical condition during the study and until 28 days after completion of this study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
25/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2028
Actual
Sample size
Target
880
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Austin Health Pharmacy Clinical Trials - Heidelberg
Recruitment hospital [3] 0 0
Southern Neurology - Kogarah
Recruitment hospital [4] 0 0
Alfred Hospital Neurology CT Dept of Neuroscience - Melbourne
Recruitment hospital [5] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [6] 0 0
Westmead Hospital Dept. of Neurology Epilepsy Unit - Westmead
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
30004 - Melbourne
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment postcode(s) [6] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Hawaii
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maine
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Utah
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
United States of America
State/province [21] 0 0
Wisconsin
Country [22] 0 0
Argentina
State/province [22] 0 0
Buenos Aires
Country [23] 0 0
Argentina
State/province [23] 0 0
Florencio Varela
Country [24] 0 0
Argentina
State/province [24] 0 0
Tucumán
Country [25] 0 0
Austria
State/province [25] 0 0
Innsbruck
Country [26] 0 0
Bulgaria
State/province [26] 0 0
Blagoevgrad
Country [27] 0 0
Bulgaria
State/province [27] 0 0
Sofia
Country [28] 0 0
Canada
State/province [28] 0 0
Alberta
Country [29] 0 0
Chile
State/province [29] 0 0
Santiago
Country [30] 0 0
Croatia
State/province [30] 0 0
Zagreb
Country [31] 0 0
Czechia
State/province [31] 0 0
Prague
Country [32] 0 0
Germany
State/province [32] 0 0
Frankfurt
Country [33] 0 0
Germany
State/province [33] 0 0
Ulm
Country [34] 0 0
Hungary
State/province [34] 0 0
Budapest
Country [35] 0 0
Israel
State/province [35] 0 0
Jerusalem
Country [36] 0 0
Israel
State/province [36] 0 0
Tel Aviv
Country [37] 0 0
Italy
State/province [37] 0 0
Bologna
Country [38] 0 0
Poland
State/province [38] 0 0
Bydgoszcz
Country [39] 0 0
Poland
State/province [39] 0 0
Gdansk
Country [40] 0 0
Poland
State/province [40] 0 0
Lublin
Country [41] 0 0
Poland
State/province [41] 0 0
Nowa Sól
Country [42] 0 0
Poland
State/province [42] 0 0
Warsaw
Country [43] 0 0
Portugal
State/province [43] 0 0
Coimbra
Country [44] 0 0
Portugal
State/province [44] 0 0
Guimarães
Country [45] 0 0
Portugal
State/province [45] 0 0
Porto
Country [46] 0 0
Portugal
State/province [46] 0 0
Santa Maria Da Feira
Country [47] 0 0
Spain
State/province [47] 0 0
Baracaldo
Country [48] 0 0
Spain
State/province [48] 0 0
Barcelona
Country [49] 0 0
Spain
State/province [49] 0 0
Madrid
Country [50] 0 0
Spain
State/province [50] 0 0
Málaga
Country [51] 0 0
Spain
State/province [51] 0 0
Valencia
Country [52] 0 0
Spain
State/province [52] 0 0
Valladolid
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Birmingham
Country [54] 0 0
United Kingdom
State/province [54] 0 0
London

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
This study will evaluate the long term safety, tolerability, PK, and efficacy of XEN1101 in subjects with Focal Onset Seizures (FOS) or Primary Generalized Tonic-Clonic Seizures (PGTCS) for the treatment of seizures for up to 3 years.
Trial website
https://clinicaltrials.gov/study/NCT05718817
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05718817