Zonisamide vs placebo in elderly patients with epilepsy

• Research type

  Research Study

• Full title

  A randomised, double blind, placebo-controlled study to evaluate the safety and tolerability and to explore the efficacy of zonisamide as add-on therapy in elderly patients with refractory partial seizures

• IRAS ID

  5149

• Sponsor organisation

  Eisai Global Clinical Development

• Eudract number

  2006-002516-10

• ISRCTN Number

  n/a

• Research summary

  Zonisamide (zon-is-a-mide) is currently approved to treat a certain form of epileptic seizures called partial seizures when given with other anti-epileptic drugs in adults. The aim of this study is to find out if zonisamide affects memory and concentration in elderly patients and whether zonisamide may make patients feel tired. The study also aims to find out how well zonisamide works in older patients and to gather more information on the safety of taking zonisamide.This trial will consist of 2 treatment groups. One group will receive zonisamide plus their currrent treatment and the other group will receive placebo plus their current treatment. Neither the patient nor the study doctors will know which patients will be receiving zonisamide and which will be receiving placebo.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  08/H1306/148

• Date of REC Opinion

  4 Dec 2008

• REC opinion

  Further Information Favourable Opinion