X-TOLE
Research type
Research Study
Full 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.
IRAS ID
258769
Contact name
Khalid Hamandi
Contact email
Sponsor organisation
Xenon Pharmaceuticals Inc
Eudract number
2018-003221-29
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
0, 0
Duration of Study in the UK
5 years, 3 months, 30 days
Research summary
This is a phase 2, multicentre, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and tolerability of increasing doses of study drug XEN1101 being administered as adjunctive treatment in adult patient diagnosed with focal epilepsy.
Focal (or partial) seizures account for 60-70% of seizures in adults with epilepsy. Currently available anti-epileptic drugs act only by a limited number of mechanisms of action. XEN1101 study drug is a novel, small molecule, selective potassium channel positive allosteric modulator being developed for the treatment of partial onset (focal) epilepsy. This mechanism has been clinically proven to be effective for treatment of partial onset seizures in adults with epilepsy. XEN1101 has been investigated at single doses of 5, 15, 20, 25 and 30 mg, as well as multiple doses of 15 or 25 mg once daily for up to 10 days in healthy volunteers and has reported to be well tolerated.
In this Phase 2 study approximately 50-100 patients will be assigned per treatment arm. Study population for this trial will be male and female patients between 18-75 years of age, diagnosed with focal epilepsy. Study duration per patient is estimated to be 26 weeks or approximately 5-6 months. Number of patients screened is approximately 400 considering screen failures and drop-outs. 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). The masking is double; patients and Investigators will be blind to treatment allocation. Randomization will be stratified by background use versus non-use of a CYP3A4 inducer medication (e.g., any of carbamazepine, eslicarbazepine, oxcarbazepine, phenytoin, topiramate or phenobarbital).
This clinical trial is sponsored by Xenon Pharmaceuticals Inc. The study will enrol approximately 25 patients at 6 sites in the UK.
REC name
London - Brent Research Ethics Committee
REC reference
19/LO/0357
Date of REC Opinion
21 May 2019
REC opinion
Further Information Favourable Opinion