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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05667142




Registration number
NCT05667142
Ethics application status
Date submitted
19/12/2022
Date registered
28/12/2022

Titles & IDs
Public title
A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic 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 Primary Generalized Tonic-Clonic Seizures
Secondary ID [1] 0 0
2022-502286-16-00
Secondary ID [2] 0 0
XPF-010-303
Universal Trial Number (UTN)
Trial acronym
X-ACKT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Generalized 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
Treatment: Drugs - Placebo
Treatment: Drugs - XEN1101

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

Placebo comparator: Placebo - Placebo

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


Treatment: Drugs: XEN1101
XEN1101 capsules

Treatment: Drugs: Placebo
Placebo capsules

Treatment: Drugs: XEN1101
XEN1101 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) PGTCS frequency
Timepoint [1] 0 0
Baseline through DBP (Week 12)
Secondary outcome [1] 0 0
Proportion of subjects
Timepoint [1] 0 0
Baseline through DBP (Week 12)
Secondary outcome [2] 0 0
Proportion of subjects
Timepoint [2] 0 0
Baseline through Week 12

Eligibility
Key inclusion criteria
1. Subject is properly informed of the nature and risks of the study and gives informed consent in writing prior to entering the study (for adult subjects) and for adolescent subjects parent/legal guardian and subject gives informed consent or assent in writing prior to entering the study.
2. Subject is =12 years of age with a BMI =40 kg/m2 at Visit 1.
3. 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.
4. Subject has probable or possible PGTCS (with or without other subtypes of generalized seizures) for =1 year, in the setting of generalized epilepsy according to the International League Against Epilepsy 2017 classification criteria, and subject is approved by The Epilepsy Study Consortium (TESC).
5. Subject is on a stable dose of 1 to 3 allowable current ASMs for at least 1 month prior to screening (Visit 1), during screening/baseline, and throughout the DBP.
6. 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 has had status epilepticus within the 12 months prior to Visit 1.
2. Subject has history of repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted.
3. Subject has a history of non-epileptic psychogenic seizures.
4. Subject has a concomitant diagnosis of FOS.
5. Subject has presence or history of a developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome.
6. Subject has seizures secondary to drug or alcohol use, ongoing infection, neoplasia, demyelinating disease, degenerative neurological disease, metabolic illness, progressive structural lesion, encephalopathy, or progressive CNS disease.
7. Subject has history of neurosurgery for seizures <1 year prior to Visit 1, or radiosurgery <2 years prior to Visit 1.
8. Subject has schizophrenia and other psychotic disorders (eg, schizophreniform disorder, schizoaffective disorder, psychosis not otherwise specified), bipolar disorder, obsessive-compulsive disorder, or another serious mental health disorder. Subject has uncontrolled unipolar major depression where changes in pharmacotherapy are needed or anticipated during the study.
9. Subject has any clinically significant laboratory abnormalities or clinically significant abnormalities on prestudy physical examination, vital signs, or ECG that, in the judgment of the investigator, indicate a medical problem that would preclude study participation, including but not limited to:

a. History or presence of long QT syndrome; QTcF >450 msec at baseline; family history of sudden death of unknown cause.
10. Any personal circumstance that, in the opinion of the investigator, prevents adherence to the protocol.

The criteria to be eligible for randomization are:

1. During the last 56 days of the baseline period that preceded the randomization visit (Visit 2), subject must have had a sufficient documented seizure frequency of PGTCS, including =1 PGTCS during each of the first and second 4-week periods preceding randomization.
2. Seizure diary was completed a minimum of 80% of all days (ie, =45 days) during the last 56 days of the baseline period that preceded randomization as evidence of adequate compliance.
3. Subject did not change dose of, stop, or initiate any new ASM(s) during the baseline period and plans on maintaining a stable dose of ASM(s) during the DBP.

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
14/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Southern Neurology - Kogarah
Recruitment hospital [2] 0 0
Mater Misericordiae Ltd - South Brisbane
Recruitment hospital [3] 0 0
Melbourne Brain Centre - Heidelberg
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [5] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
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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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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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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Ohio
Country [17] 0 0
United States of America
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Utah
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United States of America
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Washington
Country [21] 0 0
United States of America
State/province [21] 0 0
Wisconsin
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Blagoevgrad
Country [23] 0 0
Bulgaria
State/province [23] 0 0
Sofia
Country [24] 0 0
Canada
State/province [24] 0 0
Alberta
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Croatia
State/province [26] 0 0
Osijek
Country [27] 0 0
Croatia
State/province [27] 0 0
Rijeka
Country [28] 0 0
Croatia
State/province [28] 0 0
Zagreb
Country [29] 0 0
Czechia
State/province [29] 0 0
Prague
Country [30] 0 0
Italy
State/province [30] 0 0
Roma
Country [31] 0 0
Poland
State/province [31] 0 0
Bydgoszcz
Country [32] 0 0
Poland
State/province [32] 0 0
Gdansk
Country [33] 0 0
Poland
State/province [33] 0 0
Lublin
Country [34] 0 0
Poland
State/province [34] 0 0
Nowa Sól
Country [35] 0 0
Portugal
State/province [35] 0 0
Guimarães
Country [36] 0 0
Portugal
State/province [36] 0 0
Lisboa
Country [37] 0 0
Spain
State/province [37] 0 0
Madrid
Country [38] 0 0
Spain
State/province [38] 0 0
Málaga
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Wales

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
Trial website
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
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05667142