Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures
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|ClinicalTrials.gov Identifier: NCT01229735|
Recruitment Status : Completed
First Posted : October 28, 2010
Results First Posted : February 12, 2016
Last Update Posted : August 15, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: Levetiracetam Drug: Topiramate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||343 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||November 2010|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
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
250 mg and 500 mg levetiracetam tablet 1000 mg/day (500 mg bid) levetiracetam (maximum to 3000 mg/day) Duration: maximum 52 weeks
Other Name: Keppra
Active Comparator: Topiramate
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
25 mg and 100 mg topiramate tablet 100 mg/day(50 mg bid) topiramate (maximum to 400 mg/day) Duration: maximum 52 weeks
- 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 [ Time Frame: From Baseline to Week 52 ]
- Number of Subjects With at Least One Adverse Event Reported During the Trial Period From Baseline to Week 52 [ Time Frame: From Baseline to Week 52 ]
- Time From the First Study Treatment Intake to Drug Discontinuation Due to Adverse Event (AE) [ Time Frame: From Baseline to Week 52 ]
- Median Percent Reduction in the Weekly Partial Onset Seizure (POS) Frequency From Baseline During the Total Treatment Period From Baseline to Week 52 [ Time Frame: From Baseline to Week 52 ]Reduction from baseline was defined as baseline value minus post-baseline value and therefore is the negative of the change from baseline value.
- 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 [ Time Frame: From Baseline to Week 52 ]
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|Ages Eligible for Study:||16 Years to 80 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01229735
|Study Director:||UCB Clinical Trial Call Center||1 877 822 9493 (UCB)|
|Responsible Party:||UCB Korea Co., Ltd.|
|Other Study ID Numbers:||
|First Posted:||October 28, 2010 Key Record Dates|
|Results First Posted:||February 12, 2016|
|Last Update Posted:||August 15, 2017|
|Last Verified:||July 2017|
Central Nervous System Diseases
Nervous System Diseases
Physiological Effects of Drugs