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A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures

PHASE3RECRUITING

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Study details:

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in subjects diagnosed with generalized epilepsy and experiencing probable or possible PGTCS (with or without other subtypes of generalized seizures), and taking 1 to 3 anti-seizure medications (ASMs). Eligible subjects will be randomly assigned 1:1 to XEN1101 or placebo: subjects aged ≥ 18 years will receive XEN1101 25 mg or placebo, and subjects aged ≥12 years and \<18 years will receive either XEN1101 15 mg, 25 mg, or placebo. Randomization will be stratified based on region, age group, and background use of CYP3A4-inducer ASMs.

Eligible subjects will have up to 9. 5 weeks durations to assess the baseline frequency of seizures, followed by a double-blind treatment period (DBP) where subjects will receive 12 weeks of blinded treatment. 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 enroll in a separate open-label-extension (OLE) study for continued treatment with XEN1101. Subjects who do not enroll in the OLE will enter an 8 week post-treatment follow-up period.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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.

Subject is ≥12 years of age with a BMI ≤40 kg/m2 at Visit 1.

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.

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).

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.

Subject is able to keep accurate seizure diaries.

Exclusion criteria

Subject has had status epilepticus within the 12 months prior to Visit 1.

Subject has history of repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted.

Subject has a history of non-epileptic psychogenic seizures.

Subject has a concomitant diagnosis of FOS.

Subject has presence or history of a developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome.

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.

Subject has history of neurosurgery for seizures <1 year prior to Visit 1, or radiosurgery <2 years prior to Visit 1.

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.

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.

Any personal circumstance that, in the opinion of the investigator, prevents adherence to the protocol.

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Eligibility

Age eligible for study : 12 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-02-14

Primary completion: 2025-06-01

Study completion finish: 2025-10-01

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT05667142

Intervention or treatment

DRUG: XEN1101

DRUG: Placebo

DRUG: XEN1101

Conditions

• Primary Generalized Tonic-Clonic Seizures

Image related to Primary Generalized Tonic-Clonic Seizures

Condition: Primary Generalized Tonic-Clonic Seizures
DRUG: XEN1101 and other drugs
Kogarah, New South Wales, Australia and more
Sponsor: Xenon Pharmaceuticals Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Southern Neurology

Research sites nearby

Select from list below to view details:

Southern Neurology
Kogarah, New South Wales, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Not Specified, Australia
Mater Misericordiae Ltd
South Brisbane, Queensland, Australia

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?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: XEN1101 25 mg/day XEN1101 25 mg/day	DRUG: XEN1101 XEN1101 capsules
PLACEBO_COMPARATOR: Placebo Placebo	DRUG: Placebo Placebo capsules
EXPERIMENTAL: XEN1101 15 mg/day XEN1101 15 mg/day	DRUG: XEN1101 XEN1101 capsules

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Median percent change (MPC) in monthly (28 days) PGTCS frequency	Median percent change (MPC) in monthly (28 days) PGTCS frequency from baseline through the DBP for XEN1101 versus placebo.	Baseline through DBP (Week 12)

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Proportion of subjects	Proportion of subjects experiencing ≥50% reduction in monthly (28 days) PGTCS frequency from baseline through the DBP for XEN1101 versus placebo.	Baseline through DBP (Week 12)
Proportion of subjects	Proportion of subjects experiencing PGTCS freedom from baseline through the DBP for XEN1101 versus placebo.	Baseline through Week 12

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures