Eslicarbazepine acetate monotherapy in newly diagnosed focal epilepsy

• Research type

  Research Study

• Full title

  BIA-2093-311: Efficacy and safety of eslicarbazepine acetate (BIA 2-093) as monotherapy for patients with newly diagnosed partial-onset seizures: A double-blind, randomized, active-controlled, parallel-group, multicenter clinical study

• IRAS ID

  29675

• Contact name

  Manny Bagary

• Sponsor organisation

  BIAL - Portela & Ca, S.A.

• Eudract number

  2009-011135-13

• ISRCTN Number

  n/a

• Research summary

  This is a study in 900 subjects aged 18 and over who have been newly diagnosed with partial onset seizures related to epilepsy. The study consists of a screening visit, a one week titration period, a one week stabilisation period at full dose and a 26 week treatment period. Subjects may continue into an extension period until database lock in 2013 if they are seizure free during their final treatment period. Subjects will enter the study at dose level A and may be up-titrated to dose level B and dose level C if they suffer from seizures during the treatment period at the previous dose. Four weeks after the end of treatment patients will attend the clinic for a follow up visit. Dose level ATitration period: Eslicarbazepine (ESL) 400mg Once Daily (OD), Carbazepine (CBZ) 200mg Once Daily Stabilisation/treatment period: ESL 800mg OD plus placebo OD, CBZ 200mg Twice Daily (BD)If seizure during treatment period - titrate to dose level BDose level BTitration period: ESL 1200mg OD plus placebo OD, CBZ 300mg BDStabilisation/treatment period: ESL 1200mg OD plus placebo OD, CBZ 400mg BDIf seizure during treatment period titrate to dose level CDose level CTitration period: ESL 1600mg OD plus placebo OD, CBZ 500mg BDStabilisation/treatment period: ESL 1600mg OD plus placebo OD, CBZ 600mg BDIf seizure during treatment period subject must be withdrawn from study extension period: ESL or CBZ at final treatment period dose until database lock (November 2013). Subjects suffering seizures during the final treatment period at dose level C or during the extension period they will be withdrawn. ESL is an OD medication and CBZ is given BD - a placebo will be given for the second dose in the ESL group and also for the CBZ group at titration level A and dose level B in order to maintain the study blind.

• REC name

  North East - York Research Ethics Committee

• REC reference

  10/H0903/29

• Date of REC Opinion

  13 Sep 2010

• REC opinion

  Further Information Favourable Opinion