Phase 4
N=343
Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures
Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT01229735 ↗Enrolled (actual)
343
Serious AEs
7.3%
Results posted
Feb 2016
Primary outcome: Primary: 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 — 59.1; 56.6 percentage of subjects — p==0.7007
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Levetiracetam (Drug); Topiramate (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- UCB Korea Co., Ltd.
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
59.1; 56.6 | =0.7007 |
| SECONDARY Number of Subjects With at Least One Adverse Event Reported During the Trial Period From Baseline to Week 52 |
125; 128 | — |
| SECONDARY Time From the First Study Treatment Intake to Drug Discontinuation Due to Adverse Event (AE) |
NA; NA | — |
| SECONDARY Median Percent Reduction in the Weekly Partial Onset Seizure (POS) Frequency From Baseline During the Total Treatment Period From Baseline to Week 52 |
74.47; 67.86 | — |
| SECONDARY 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 |
120; 107 | — |
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)
Data sourced from ClinicalTrials.gov (NCT01229735). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.