Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
Lead Sponsor:
Xenon Pharmaceuticals Inc.
Collaborating Sponsors:
Novotech Health Holdings Pte. Ltd.
Conditions:
Focal Epilepsy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
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, safet...
Eligibility Criteria
Inclusion
- Key
- 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
- 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:
- History of presence of long QT syndrome; QTcF \> 450 msec at baseline; family history of sudden death of unknown cause
- 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
Key Trial Info
Start Date :
January 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2028
Estimated Enrollment :
325 Patients enrolled
Trial Details
Trial ID
NCT03796962
Start Date
January 30 2019
End Date
October 1 2028
Last Update
September 24 2024
Active Locations (95)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Strada Patient Care Center
Mobile, Alabama, United States, 36604
3
Xenoscience, Inc.
Phoenix, Arizona, United States, 85004
4
Clinical Trials, Inc.
Little Rock, Arkansas, United States, 72205