Extension study - Zonisamide in Patients with Partial Epilepsy

• Research type

  Research Study

• Full title

  A randomized, double-blind extension study to assess long-term safety and to explore long-term efficacy of zonisamide as monotherapy in newly diagnosed partial epilepsy

• IRAS ID

  3135

• Sponsor organisation

  Eisai Limited

• Eudract number

  2008-001159-23

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is a double-blind extension of the E2090-E044-310 study (A randomized, multi-centre, double-blind study, to compare the efficacy and safety of zonisamide and carbamazepine as monotherapy, in newly diagnosed partial epilepsy). The purpose of this extension study is to provide continued treatment for subjects completing the E2090-E044-310 study, as well as to assess the long-term safety, efficacy and tolerability of zonisamide.During this extension study, the subject will continue to take the same study drug (zonisamide or carbamazepine) at the same dose as he/she was taking in the original study. When all the patients have completed the E2090-E044-310 study, it will be Ó?unblinded? (this means we will find out which study drug each patient is taking). Subjects found to be taking zonisamide, will continue to take it in this extension study until either zonisamide is marketed in the UK, or until it is decided that no further research will be done on zonisamide in this indication. If zonisamide is not being marketed in the UK, the investigator will need to apply to the Sponsor (Eisai Limited) for compassionate use in order to continue treating the patient. Subjects found to be taking carbamazepine will be discontinued from this study, as this is a marketed product that is available for use. During the extensions study, the subject will need to visit the study doctor every 13 weeks, during which the subject??s seizure diary will be reviewed; questionnaires will be completed to assess the subject??s quality of life; the study doctor will perform a physical and neurological exam, and study medication will be dispensed and returned. If the patient discontinues from the study, a final visit will be performed, followed by a follow-up visit and will receive a phone call 15 days after receiving the final dose.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  08/H0703/71

• Date of REC Opinion

  4 Dec 2008

• REC opinion

  Further Information Favourable Opinion