The SKATE study: an open-label community-based study of levetiracetam as add-on therapy for adults with uncontrolled partial epilepsy

Details

Serval ID
serval:BIB_6C0BD1EBD551
Type
Article: article from journal or magazin.
Collection
Publications
Title
The SKATE study: an open-label community-based study of levetiracetam as add-on therapy for adults with uncontrolled partial epilepsy
Journal
Epilepsy Res
Author(s)
Steinhoff B. J., Somerville E. R., Van Paesschen W., Ryvlin P., Schelstraete I.
ISSN
0920-1211 (Print)
ISSN-L
0920-1211
Publication state
Published
Issued date
08/2007
Volume
76
Number
1
Pages
6-14
Language
english
Notes
Steinhoff, Bernhard J
Somerville, Ernest R
Van Paesschen, Wim
Ryvlin, Philippe
Schelstraete, Isabelle
eng
Clinical Trial, Phase IV
Multicenter Study
Research Support, Non-U.S. Gov't
Netherlands
Epilepsy Res. 2007 Aug;76(1):6-14. doi: 10.1016/j.eplepsyres.2007.06.002. Epub 2007 Aug 6.
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.
Keywords
Adolescent, Adult, Anticonvulsants/*therapeutic use, Drug Administration Schedule, Drug Therapy, Combination, Epilepsies, Partial/*drug therapy, Female, Health Status, Humans, International Cooperation, Male, Middle Aged, Piracetam/*analogs & derivatives/therapeutic use, Quality of Life, *Residence Characteristics, Retrospective Studies, Single-Blind Method, Treatment Outcome
Pubmed
Create date
29/11/2018 13:37
Last modification date
20/08/2019 15:26
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