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

UCB

Status and phase: Completed; Phase 4

Conditions: Epilepsy

Treatments: Drug: Levetiracetam; Drug: Topiramate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01229735

N01353

Details and patient eligibility

About

To assess the long-term effects of levetiracetam on retention rate in subjects with refractory partial onset seizure that are not fully controlled with 1 to 3 concomitant antiepileptic drugs, compared to topiramate as add-on therapy during 52 weeks.

Enrollment: 343 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

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 V1 according to ILAE classification
• Subjects having at least 1 partial onset seizures whether or not secondarily generalized per 4 weeks preceding V2 according to ILAE classification
• Subjects with each interval of partial onset seizures less than 6 weeks during entire 12 weeks (8 weeks preceding V1 and 4 weeks preceding V2)
• Subjects being uncontrolled while treated by 1 to 3 permitted concomitant AEDs.
• Permitted concomitant AEDs having been stable and at optimal dosage for the subject from at least 4 week before V1 and during 4 weeks preceding V2 and expected to be kept stable during the Treatment Period.

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 V2.
• Presence of exclusively type IA non-motor seizures.
• History or presence of status epilepticus within last 3 months preceding V1 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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343 participants in 2 patient groups

Levetiracetam

Experimental group

Description:

250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks

Treatment:

Drug: Levetiracetam

Topiramate

Active Comparator group

Description:

25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks

Treatment:

Drug: Topiramate