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Efficacy and Safety Study of BIA 2-093 in Combination With Other Anti-Epileptic Drugs to Treat Partial Epilepsy

NCT00957047 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 395

Last updated 2025-03-25

Study results available
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Summary

The primary objective of the study is to evaluate the efficacy of eslicarbazepine acetate once-daily at doses of 400 mg, 800 mg and 1200 mg compared with placebo as adjunctive therapy in patients with refractory partial epilepsy over a 12-week maintenance period. Patients who complete Part I may enter a 1-year open-label extension.

Conditions

  • Partial Epilepsy

Interventions

DRUG

eslicarbazepine acetate

oral tablets

DRUG

placebo

once daily placebo comparator

DRUG

ESL - Part II

Eslicarbazepine acetate was supplied as scored 800-mg tablets for daily oral administration.

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Principal Investigators

  • Elinor Ben-Menachem, MD · Sahlgren University Hospital, Göteborg, Sweden

  • Alberto Alain Gabbai, MD · Rua Pedro de Toledo 655, Vila Clemento, Sao Paulo, Brazil

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2006-08-31
Completion
2008-01-31

Countries

  • Portugal

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 NCT00957047 on ClinicalTrials.gov