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SKATE: Safety of Keppra as Adjunctive Therapy in Epilepsy
NCT00643500Phase 4
Key facts
- Status
- Completed
- Start
- Jan 2002
- Primary completion
- May 2003
- Sponsor
- UCB
- Modality
- Small Molecules
- Drugs
- levetiracetam
- Conditions
- epilepsy
01
Overview
Phase 4, open-label, single-arm trial of levetiracetam in epilepsy, sponsored by UCB. Primary endpoints: Adverse event rates at 16 weeks, Seizure counts at 16 weeks and 1 more. Started Jan 2002; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Levetiracetam Add-on
Levetiracetam administered as adjunctive therapy to patients with partial-onset seizures.
03
Who it enrols
Patients older than 16 years with partial onset seizures (with or without secondary generalization) taking at least one concomitant marketed anti-epileptic drug.
04
Endpoints
Primary
Adverse event rates
Seizure counts
Quality of Life
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