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Efficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial Epilepsy

NCT00957372 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2014-07-02

Study results available
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Summary

The primary objective was to evaluate the efficacy of eslicarbazepine acetate (ESL) administered once daily at 1200 mg or 800 mg, compared with placebo as adjunctive therapy in patients with refractory partial epilepsy over a 12-week maintenance period.

Conditions

  • Partial Epilepsy

Interventions

DRUG

eslicarbazepine acetate

oral tablet, 800 mg or 1200 mg once daily

DRUG

placebo (Part I)

once daily placebo comparator

DRUG

ESL - Open-label Extension (Part II)

Part II was a 1-year open-label extension for patients who had completed Part I. Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Principal Investigators

  • Antonio Gil-Nagel, MD · Hospital Ruber Internacional La Masó 38, Mirasierra 28034 Madrid, Spain

  • Jose Lopes-Lima, MD · Hospital Santo António Largo Prof. Abel Salazar, 4099-001 Porto, Portugal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • Portugal

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00957372 on ClinicalTrials.gov