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Efficacy and Safety of Eslicarbazepine Acetate as Monotherapy for Patients With Newly Diagnosed Partial-onset Seizures

NCT01162460 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 815

Last updated 2016-09-29

No results posted yet for this study

Summary

The purpose of this study is to investigate the efficacy and safety of eslicarbazepine acetate (BIA 2-093) as monotherapy for patients with newly diagnosed partial-onset seizures.

Conditions

Interventions

DRUG

Eslicarbazepine acetate (BIA 2-093)

Week 1 and 2 either 400mg/day Eslicarbazepine acetate (ESL) or 200mg/day Carbamazepine controlled release(CBZ-CR); Week 3 onwards either 800mg/day Eslicarbazepine acetate or 400mg/day CBZ-CR; this dose then to be maintained unless a subject has a seizure. Subjects experiencing a seizure will have their assigned treatment dose increased to ESL 1200mg/day or CBZ 800mg/day. Should a subject have another seizure, their assigned treatment is to be increased to ESL 1600mg/day or CBZ 1200mg/day. Subjects who remain seizure free for 26 weeks at any dose in an Evaluation Period will continue to receive the allocated treatment under double-blind conditions.

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • Portugal

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Entities

Diseases

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 NCT01162460 on ClinicalTrials.gov