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

NCT00988429 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 653

Last updated 2021-05-19

Study results available
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Summary

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

Conditions

  • Partial Epilepsy

Interventions

DRUG

800 mg QD Eslicarbazepine acetate

Oral, 800 mg QD, 2-week titration period and 12-week maintenance period

DRUG

1200 mg QD Eslicarbazepine acetate

Oral, 1200 mg QD, 2-week titration followed by 12-week maintenance period

DRUG

Placebo

Placebo tablet given QD

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    collaborator INDUSTRY

  • Bial - Portela C S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-02
Primary Completion
2012-01-12
Completion
2012-01-12

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Canada
  • Cyprus
  • France
  • Germany
  • Greece
  • Italy
  • Poland

Study Locations

More Related Trials

Entities

Drugs

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 NCT00988429 on ClinicalTrials.gov