A multicenter study to evaluate the safety, tolerability and efficacy of XEN1101 as additional therapy to standard treatment in focal epilepsy.

Phase 1

• Conditions: Adult focal (partial onset) epilepsy; MedDRA version: 20.0 Level: LLT Classification code 10065337 Term: Focal epilepsy System Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-003221-29-ES
• Lead Sponsor: Xenon Pharmaceuticals Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-22
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 300

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 <35 kg/m2
- Diagnosis (=2 years) of focal epilepsy according to the International League Against Epilepsy [ILAE] Classification of Epilepsy (2017)
- 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 study
- Must be willing to comply with the contraception requirements
- Able to keep accurate seizure diaries
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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
- 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 =49 days and acceptable hematology and LFT values (or discontinued felbamate 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified