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Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures - NCT00988429-(Clinical Trial 676604)



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City:  Voorhees
State:  
NJ
Zip Code:
Conditions: Partial Epilepsy
Purpose: The purpose of this study is to determine whether Eslicarbazepine acetate (BIA 2-093)is an effective adjunct therapy in the treatment of refractory partial seizures
Study summary: The efficacy of Eslicarbazepine acetate (BIA 2-093)will be evaluated at doses of 800 mg and 1200 mg once daily over a 12-week maintenance period. This is a 2-part study. Part I will follow a parallel-group, randomised, placebo-controlled design and will consist of an 8-week baseline period, followed by a double-blind 2-week titration period and a 12-week maintenance period. At the end of the 8-week baseline period, patients will be randomly assigned to one of three treatment groups in a 1:1:1 ratio: Placebo (Group 1; n=120), Eslicarbazepine acetate 800 mg QD (Group 2; n=120) and Eslicarbazepine acetate 1200 mg QD (Group 3; n=120). Patients who complete Part I may enter a 1-year open-label extension (Part II) with Eslicarbazepine acetate, starting with a dose of 800 mg QD for one month. Thereafter, investigators can titrate the dose upwards or downwards.
Criteria: Inclusion Criteria: - Diagnosis of epilepsy for at least 12 months prior to screening - At least 4 partial-onset seizures in the 4 weeks prior to screening - Currently taking 1 or 2 AEDs - Aged 16+ years Exclusion Criteria: - Only simple partial seizures with no motor symptomatology - Primarily generalised seizures - Known progressive neurological disorders - Currently taking oxcarbazepine
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Data Source: ClinicalTrials.gov
Date Processed: January 6, 2011
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