evetiracetam versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures

• Conditions: Refractory Partial Onset Seizures; MedDRA version: 18.1Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-004402-15-Outside-EU/EEA
• Lead Sponsor: CB Korea Co.,Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-27
• Last Update Posted: 16 November 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

• Male or female subjects from 16 to 80 years, inclusive. Subjects under 20 years may only be included where legally permitted and ethically accepted
• Subjects with refractory epilepsy with partial onset seizure classifiable according to the International League Against Epilepsy (ILAE)
• Subjects having at least 2 partial onset seizures whether or not secondarily generalized during the 8 weeks historical Baseline preceding Visit 1 according to ILAE classification
• Subjects having at least 1 partial onset seizures whether or not secondarily generalized per 4 weeks preceding Visit 2 according to ILAE classification
• Subjects with each interval of partial onset seizures less than 6 weeks during entire 12 weeks (8 weeks preceding Visit 1 and 4 weeks preceding Visit 2)
• Subjects being uncontrolled while treated by 1 to 3 permitted concomitant antiepileptic drugs (AEDs)
• Permitted concomitant AEDs having been stable and at optimal dosage for the subject from at least 4 week before Visit 1 and during 4 weeks preceding Visit 2 and expected to be kept stable during the Treatment Period

Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

• Subjects presenting any generalized epilepsies classified as type II according to the ILAE classification (ref to publication from 1981)
• Subjects suffering from epilepsies and syndromes undetermined whether focal or generalized (classification III according to the ILAE classification)
• Subjects suffering from special syndromes (classification IV according to the ILAE classification)
• History or occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before Visit 2
• Presence of exclusively type IA non-motor seizures
• History or presence of status epilepticus within last 3 months preceding Visit 1 or during Baseline
• History or presence of known pseudo-seizures
• Subjects who are currently on vigabatrin (subjects who received vigabatrin in the past and have a normal visual field test are allowed)
• Subject taking 1 or more of the following medications on a regular basis within 28 days prior to Visit 1: antipsychotics drugs, and psychostimulant (amphetamine derivatives)

Study & Design

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