PARIS, France (May 17, 2003) - First interim results from UCB Pharma's ongoing Phase IV SKATE (Safety of KEPPRA as Adjunctive Therapy in Epilepsy) study shows favourable rates of efficacy for KEPPRA (levetiracetam) in a broad population of difficult to treat patients. Phase IV studies are considered to be close to clinical practice and specifically explore the safety of a treatment that has been registered for a particular indication. In this case the results of the SKATE study, similarly to the KEEPER study (the US equivalent Phase IV trial), show a high proportion of patients with partial onset seizures experienced an overall significant clinical improvement when treated with KEPPRA. The SKATE study showed that seizure frequency was reduced by half or more in 49% of patients
1. This efficacy was confirmed across different partial seizure types
1 and in addition, the results also showed a substantial seizure freedom rate of 17.2% over the entire study duration (sixteen weeks). It makes KEPPRA a good candidate for possibly becoming a first-choice add-on antiepileptic drug (AED).
The interim results were based on data from 731 patients recruited from nine countries; Belgium, Czech Republic, Germany, Finland, France, Netherlands, Switzerland, UK and Argentina with 117 investigators.
SKATE study design
The SKATE trial is a Phase IV, open-label, multi-centre trial studying the safety and efficacy of KEPPRA as an adjunctive therapy in adult patients with uncontrolled partial seizures, which began in April 2000. The interim results were based on a 16-week treatment period in a broad population of refractory patients, with between one and fourteen partial-onset seizures per month, averaged over the three month-period preceding the selection visit.
SKATE Study Results
Patient demographics
The mean age of patients involved in the SKATE study was 38.4 years and the mean duration of time t
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Contact: Elizabeth Park
elizabeth.park@ketchum.com
44-207-611-3624
Ketchum
17-May-2003
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