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A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy (X-TOLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03796962
Recruitment Status : Active, not recruiting
First Posted : January 8, 2019
Last Update Posted : April 19, 2024
Sponsor:
Collaborator:
Novotech Health Holdings Pte. Ltd.
Information provided by (Responsible Party):
Xenon Pharmaceuticals Inc.

Study Description
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Brief Summary:
The XEN1101 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of increasing doses of XEN1101 administered as adjunctive treatment in adult patients diagnosed with focal epilepsy, followed by an optional open-label extension (OLE).

Condition or disease Intervention/treatment Phase
Focal Epilepsy Drug: XEN1101 Phase 2

Detailed Description:
The XEN1101 Phase 2 clinical trial is designed as a randomized, double-blind, placebo-controlled, multicenter study with an optional open-label extension (OLE) to evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive treatment in adult patients aged 18 to 75 years diagnosed with focal epilepsy. Approximately 300 patients will be randomized in a blinded manner to one of three active treatment groups or placebo in a 2:1:1:2 fashion (XEN1101 25 mg : 20 mg : 10 mg : Placebo). After screening, patients will have 8 weeks of baseline to assess frequency of seizures, followed by 8 weeks of treatment and a 6-week post treatment follow-up period. In order to be included in the study, patients must already be treated with a stable dose of 1 to 3 allowable current anti-epileptic drugs for at least one month prior to screening, during baseline, and throughout the double-blind portion (DBP) of the study. During the treatment period, patients will be given XEN1101 or placebo once daily in the evening. An OLE will be available to eligible patients who complete the DBP. All patients will receive a 20 mg daily dose of XEN1101 during this extension period.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 325 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 as Adjunctive Therapy in Focal-onset Epilepsy, With an Open-label Extension
Actual Study Start Date : January 30, 2019
Actual Primary Completion Date : September 2, 2021
Estimated Study Completion Date : October 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arms and Interventions
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Arm Intervention/treatment
Experimental: 25 mg XEN1101
Capsule filled with 25 mg XEN1101
 Drug: XEN1101
Oral dose
Experimental: 20 mg XEN1101
Capsule filled with 20 mg XEN1101
 Drug: XEN1101
Oral dose
Experimental: 10 mg XEN1101
Capsule filled with 10 mg XEN1101
 Drug: XEN1101
Oral dose
Placebo Comparator: Placebo
Placebo capsule
 Drug: XEN1101
Oral dose


Outcome Measures
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Primary Outcome Measures :
  1. To assess the efficacy of XEN1101 compared to placebo on focal seizure frequency (e.g., median percent change in focal seizure frequency) in adults with focal epilepsy taking 1-3 antiepileptic drugs (AEDs) in the double-blind treatment period (DBP) [ Time Frame: From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56) ]
    Median percent change in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo

  2. To assess the safety and tolerability of XEN1101 (e.g., adverse events) in adults with focal epilepsy taking 1-3 AEDs [ Time Frame: From screening (up to 28 days prior to baseline) through to 42 days post-final dose ]
    To assess adverse events as criteria for safety and tolerability


Secondary Outcome Measures :
  1. To evaluate the 50% XEN1101 response rates in comparison to placebo in the DBP [ Time Frame: From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56) ]
    Responders are defined as patients experiencing ≥50% reduction in monthly (28 days) focal seizure frequency from baseline to DBP

  2. To evaluate trends in focal seizure frequency over time in the DBP [ Time Frame: From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56) ]
    Percent change from baseline in weekly focal seizure frequency for each week in the DBP


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • BMI ≤40 kg/m2
  • Diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy [ILAE] Classification of Epilepsy (2017)
  • Prior neuroimaging within the last 10 years and documentation is available
  • Treatment with a stable dose of 1 to 3 allowable current AEDs for at least one month prior to screening, during baseline, and throughout the duration of the DBP
  • Must be willing to comply with the contraception requirements
  • Males must agree not to donate sperm from the time of the first administration of study drug until 6 months after the last dose. Females must agree not to donate ova from the time of the first administration of study drug until 6 months after the last dose.
  • Able to keep accurate seizure diaries

Key Exclusion Criteria:

  • History of pseudoseizures, psychogenic seizures, primary generalized seizure, or focal aware non-motor seizures only
  • Presence or previous history of Lennox-Gastaut syndrome
  • Seizures secondary to other diseases or conditions
  • History of repetitive seizures within the last 12 months where the individual seizures cannot be counted
  • History of neurosurgery for seizures <1 year prior to enrollment, or radiosurgery <2 years prior to enrollment
  • Schizophrenia and other psychotic disorders, or active suicidal plan/intent in the past 6 months, or a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt
  • History or presence of any significant medical or surgical condition or uncontrolled medical illness at screening, or history of cancer within the past 2 years, with the exception of appropriately treated basal cell or squamous cell carcinoma

  • Any clinically significant abnormalities on pre-study physical examination, vital signs, laboratory values or ECG indicating a medical problem that would preclude study participation including but not limited to:

    1. History of presence of long QT syndrome; QTcF > 450 msec at baseline; family history of sudden death of unknown cause
    2. History of skin or retinal pigment epithelium abnormalities caused by ezogabine
  • Past use of vigabatrin without stable visual fields tested twice over the 12 months after the last dose of vigabatrin (concomitant use of vigabatrin is not allowed)
  • If felbamate is used as a concomitant AED, patients must be taking it for at least 2 years, with a stable dose for 2 months (or no less than 49 days) and acceptable hematology and LFT history and values prior to Screening. If received in the past, felbamate must have been discontinued 2 months (or no less than 49 days) prior to Screening.
  • Have had multiple drug allergies or a severe drug reaction to an AED(s), including dermatological (e.g., Stevens-Johnson syndrome), hematological, or organ toxicity reactions
  • Current use of a ketogenic diet
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03796962


Locations
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Sponsors and Collaborators
Xenon Pharmaceuticals Inc.
Novotech Health Holdings Pte. Ltd.
Investigators
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Study Director: Study Director Xenon Pharmaceuticals Inc.
More Information
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Responsible Party: Xenon Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03796962    
Other Study ID Numbers: XPF-008-201
2018-003221-29 ( EudraCT Number )
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: April 19, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xenon Pharmaceuticals Inc.:
Epilepsy
Additional relevant MeSH terms:
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Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases