Clinical trial NCT01229735: Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures
Official title: A Randomized, Open-label, Parallel Group, Multi-center, Comparative, Phase IV Trial of Levetiracetam (LEV) Versus Topiramate (TPM) as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy
Keywords: levetiracetam
topiramate
epilepsy
partial seizures
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2010-10-28
Enrollment: 343
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of Subjects Continuing the Allocated Investigational Treatment From the First Study Treatment Intake to Week 52, After the Beginning of Investigational Treatment With Levetiracetam Compared to Topiramate
timeFrame: From Baseline to Week 52
Secondary outcomes:
measure: Number of Subjects With at Least One Adverse Event Reported During the Trial Period From Baseline to Week 52
timeFrame: From Baseline to Week 52
measure: Time From the First Study Treatment Intake to Drug Discontinuation Due to Adverse Event (AE)
timeFrame: From Baseline to Week 52
measure: Median Percent Reduction in the Weekly Partial Onset Seizure (POS) Frequency From Baseline During the Total Treatment Period From Baseline to Week 52
timeFrame: From Baseline to Week 52
measure: Responders Defined as Number of Subjects With at Least 50 % Reduction in the Weekly POS Frequency From Baseline During the Total Treatment Period From Baseline to Week 52
timeFrame: From Baseline to Week 52
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: 14
city: Busan
country: Korea, Republic of
facility: 21
city: Busan
country: Korea, Republic of
facility: 8
city: Busan
country: Korea, Republic of
facility: 9
city: Daegu
country: Korea, Republic of
facility: 12
city: Daegu
country: Korea, Republic of
facility: 13
city: Daejeon
country: Korea, Republic of
facility: 10
city: Daejeon
country: Korea, Republic of
facility: 25
city: Gwangju
country: Korea, Republic of
facility: 15
city: Incheon
country: Korea, Republic of
facility: 7
city: Kyunggi-Do
country: Korea, Republic of
facility: 11
city: Kyunggi-do
country: Korea, Republic of
facility: 19
city: Kyunggi-Do
country: Korea, Republic of
facility: 23
city: Kyunggi-Do
country: Korea, Republic of
facility: 24
city: Seoul
country: Korea, Republic of
facility: 16
city: Seoul
country: Korea, Republic of
facility: 17
city: Seoul
country: Korea, Republic of
facility: 18
city: Seoul
country: Korea, Republic of
facility: 1
city: Seoul
country: Korea, Republic of
facility: 2
city: Seoul
country: Korea, Republic of
facility: 3
city: Seoul
country: Korea, Republic of
facility: 4
city: Seoul
country: Korea, Republic of
facility: 5
city: Seoul
country: Korea, Republic of
facility: 6
city: Ulsan
country: Korea, Republic of
facility: 22
Study officials:
affiliation: 1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: