Eisai−313 Paediatric epilepsy extension study: re-submission
Research type
Research Study
Full title
An open-label extension study following a double-blind, randomised, placebocontrolled, multi-centre study to assess the efficacy and safety of adjunctive zonisamide in paediatric partial onset seizures.
IRAS ID
31194
Contact name
Jayaprakash Gosalakkal
Sponsor organisation
Eisai Ltd
Eudract number
2007−000198−53
Clinicaltrials.gov Identifier
Research summary
Around 10 million children under the age of 15 have epilepsy. It is the most common serious neurological condition, with an annual incidence in developed countries of 50 to 70 cases per 100,000 of the population. Epilepsy is characterised by repeated seizures caused by recurrent, abnormal, and excessive discharges from cerebral neurons. The goals of treatment include: the prevention of seizures, medical management of seizures, and management of the causes and consequences of epilepsy.Pharmacological interventions against epileptic seizures have been available since the introduction of bromides in the nineteenth century. However, there is still a need for an effective, safe, and well-tolerated treatment. The lack of adequate therapy appears to be the most prominent for subjects with partial seizures, where a significant number of subjects fail to achieve satisfactory seizure control with the current anti-epileptic drugs (AEDs) in single drug treatments. Zonisamide is an AED currently approved for the adjunctive use in adults with partial seizures and has a favourable side effect profile.Participants who completed the double-blind study (E2090- E044-312) will be invited to participate in this extension study. The study consists of two main parts - Transition Period (double-blind) and Open Label Period. The study will start with the Transition Period during which participants already on zonisamide will continue on the same dose of zonisamide and those who were taking placebo will be up-titrated to an appropriate dose of zonisamide. After all participants have completed the Transition Period, the study will become open label with every subject on the study receiving zonisamide. The study medication will be taken once daily in the evening.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
09/H0408/98
Date of REC Opinion
20 Jan 2010
REC opinion
Further Information Favourable Opinion