Phase 4
N=251
Open Label Safety and Efficacy Study of Levetiracetam in Patients With Epilepsy
Epilepsy, Partial
Bottom Line
View on ClinicalTrials.gov: NCT00160654 ↗Enrolled (actual)
251
Serious AEs
6.0%
Results posted
Aug 2020
Primary outcome: Primary: Number of Patients With Adverse Events (AEs) — 184 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Levetiracetam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UCB Pharma
- Primary completion
- Dec 2006
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 | — |
Summary
Community based study assessing safety and efficacy of levetiracetam in partial onset seizures.
The optimal dose in daily clinical practice will be used.
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). 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.