Phase 4
Completed N=251
Open Label Safety and Efficacy Study of Levetiracetam in Patients With Epilepsy
Epilepsy, Partial
Source: ClinicalTrials.gov NCT00160654 ↗
Enrolled (actual)
251
Serious AEs
6.0%
Results posted
Aug 2020
Primary outcomePrimary: Number of Patients With Adverse Events (AEs) — 184 Participants
◆ Published Evidence
Established
22citations · ~1 / year
Efficacy and safety of levetiracetam as adjunctive therapy in adult patients with uncontrolled partial epilepsy: the Asia SKATE II Study.
Summary
Community based study assessing safety and efficacy of levetiracetam in partial onset seizures.
The optimal dose in daily clinical practice will be used.
Linked Publications
-
Efficacy and safety of levetiracetam as adjunctive therapy in adult patients with uncontrolled partial epilepsy: the Asia SKATE II Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adverse Events (AEs) |
184 | — |
| SECONDARY Percentage Change From Historical Baseline in Partial (Type I) Seizure Frequency Per Week Over the Treatment Period |
-48.34 | — |
| SECONDARY Percentage Change From Historical Baseline in Total (Type I+II+III) Seizure Frequency Per Week Over the Treatment Period |
-46.43 | — |
| SECONDARY Percentage of Participants With 50% Response in Seizure Frequency Per Week at Week 16 |
47.7; 48.1 | — |
| SECONDARY Percentage of Participants With 100% Response in Seizure Frequency Per Week at Week 16 |
20.2; 20.2 | — |
| SECONDARY Percentage of Patients With Categorized Change From Baseline in Severity of Illness |
34.1; 25.3; 16.5; 17.7; 3.2; 2.8 | — |
| SECONDARY Retention Rate at Week 16 |
85.3 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with epilepsy experiencing partial seizures, whether or not secondarily generalized.
- Subjects must present between 3 and 42 partial seizures over the three months prior to protocol Visit 1.
- Use of one (1), but no more than two (2) concomitant marketed antiepileptic drugs (AEDs) at the time of trial entry.
Exclusion Criteria
- Subjects on vigabatrin, whose visual field has not been assessed as per recommendation of the manufacturer, i.e. every 6 months.
- Presence of known pseudoseizures within the last year.
- Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors.
- Uncountable seizures (clusters) or history of convulsive status epilepticus within the last five years.
Data sourced from ClinicalTrials.gov (NCT00160654) and the linked publication. 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. Informational only — not medical advice.