Eisai-312 Paediatric epilepsy study A1 04/02/08

• Research type

  Research Study

• Full title

  A double-blind, randomised, placebo-controlled multi-centre study to assess the efficacy and safety of adjunctive zonisamide in paediatric partial onset seizures

• Sponsor organisation

  Eisai Limited

• Eudract number

  2006-002515-27

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Around 50 million people in theworld have epilepsy, of which approximately 10 million are children under theage of 15. It is the most common serious neurological condition, with an annualincidence in developed countries of 50 to 70 cases per 100,000 of thepopulation. Epilepsy is characterised by repeated seizures caused by recurrent,abnormal, and excessive discharges from cerebral neurons. Seizures may betriggered by the central nervous system (CNS), infections, fever, tumours,toxins, vascular disease, degenerative disease, trauma, or the cause may beunknown. In a small number of paediatric subjects seizures occur in the settingof a defined syndrome, sometimes with (presumed) genetic origin. The goals oftreatment include: the prevention of seizures, medical management of seizures,and management of the causes and consequences of epilepsy. Pharmacologicalinterventions against epileptic seizures have been available since theintroduction of bromides in the nineteenth century. However, there is still aneed for an effective, safe, and well-tolerated treatment. The lack of adequatetherapy appears to be the most prominent for subjects with partial seizures,where a significant number of subjects fail to achieve satisfactory seizurecontrol with the current anti-epileptic drugs (AEDs) in single drug treatments.Zonisamide is an AED currently approved for the adjunctive use in adults withpartial seizures and has a favourable side effect profile. Therefore this trialis conducted to evaluate the efficacy and safety of zonisamide in the paediatricpopulation with partial seizures. Each participant will be in the study for amaximum duration of 32 weeks. They will Zonisamide or placebo capsules everynight. They will take between 1 and 5 capsules each time, depending on how oldthey are.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  08/H0408/135

• Date of REC Opinion

  24 Nov 2008

• REC opinion

  Further Information Favourable Opinion