Eslicarbazepine Acetate in children with epilepsy

• Research type

  Research Study

• Full title

  Efficacy and safety of Eslicarbazepine Acetate (BIA 2-093) as adjunctive therapy for refractory partial seizures in children: a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical trial.

• IRAS ID

  18487

• Sponsor organisation

  BIAL – Portela & Ca, S.A.

• Eudract number

  2007-001887-55

• ISRCTN Number

  N/A

• Research summary

  This research is a phase III clinical trial to assess the efficacy and safety of Eslicarbazepine Acetate as adjunctive therapy in children and adolescents with refractory partial epilepsy who are treated with anti-epileptic drugs. The clinical trial has two phases, the first is a randomised, double-blind, placebo-controlled, parallel-group phase. The second is an open label extension phase. Participants will have the option to continue receiving the investigational product until marketing authorisation is granted (or clinical development is discontinued) if it is in their best interest.

• REC name

  North East - York Research Ethics Committee

• REC reference

  09/H0903/17

• Date of REC Opinion

  3 Apr 2009

• REC opinion

  Further Information Favourable Opinion