Abstract |
The Safety of Keppra as Adjunctive Therapy in Epilepsy (SKATE) study aimed to evaluate the safety and efficacy of levetiracetam ( Keppra, LEV) as add-on therapy for refractory partial seizures in clinical practice. This Phase IV, 16-week, open-label study recruited patients > or =16-year old with treatment-resistant partial seizures. LEV (1000 mg/day) was added to a stable concomitant antiepileptic drug regimen. LEV dosage was adjusted based on seizure control and tolerability to a maximum of 3000 mg/day. 1541 patients (intent-to-treat population) were recruited including 1346 (87.3%) who completed the study and 77.0% who declared further continuing on LEV after the trial. Overall, 50.5% of patients reported at least one adverse event that was considered related to LEV treatment. The most frequently reported drug-related adverse events were mild-to-moderate somnolence, fatigue, dizziness and headache. Serious adverse events considered related to LEV occurred in 1.0% of patients. 7.5% of patients reported adverse events as the most important reason for study drug discontinuation. The median reduction from baseline in the frequency of all seizures was 50.2%; 15.8% of patients were seizure free; 50.1% had seizure frequency reduction of > or =50%. At the end of the study, 60.4% of patients were considered by the investigator to show marked or moderate improvement. There was a significant improvement in health-related quality of life as assessed with the QOLIE-10-P (total score increasing from 55.6 to 61.6; p<0.001). This community-based study suggests that LEV is well tolerated and effective as add-on therapy for refractory partial seizures in adults. These data provide supportive evidence for the safety and efficacy of LEV demonstrated in the pivotal Phase III placebo-controlled studies.
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Authors | Bernhard J Steinhoff, Ernest R Somerville, Wim Van Paesschen, Philippe Ryvlin, Isabelle Schelstraete |
Journal | Epilepsy research
(Epilepsy Res)
Vol. 76
Issue 1
Pg. 6-14
(Aug 2007)
ISSN: 0920-1211 [Print] Netherlands |
PMID | 17681453
(Publication Type: Clinical Trial, Phase IV, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anticonvulsants
- Levetiracetam
- Piracetam
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Topics |
- Adolescent
- Adult
- Anticonvulsants
(therapeutic use)
- Drug Administration Schedule
- Drug Therapy, Combination
- Epilepsies, Partial
(drug therapy)
- Female
- Health Status
- Humans
- International Cooperation
- Levetiracetam
- Male
- Middle Aged
- Piracetam
(analogs & derivatives, therapeutic use)
- Quality of Life
- Residence Characteristics
- Retrospective Studies
- Single-Blind Method
- Treatment Outcome
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