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EXTENT: EXtended Tolerability and Efficacy of a Novel Formulation of Oxcarbazepine in a Trial in Partial Epilepsy

NCT00391534 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2010-04-15

No results posted yet for this study

Summary

This study is intended to investigate the safety and efficacy of a novel formulation of oxcarbazepine that is released more slowly than the current formulation. The study medication will be used as a treatment against partial epilepsy.

Conditions

  • Partial Epilepsy

Interventions

DRUG

modified release formulation of oxcarbazepine (OXC MR)

Patients who are pre-treated with a total daily dose of exactly 900 or exactly 1200 mg or exactly 1500 mg oxcarbazepine (as OXC IR) will increase dosage of OXC by 300 mg to a daily dose of 1200 mg / 1500 mg / 1800 mg OXC MR. Dosage will be titrated to a maximum tolerated total daily dose, maximally to 2700 mg in steps of 300 mg every 6th day.

DRUG

immediate release formulation of oxcarbazepine (OXC IR)

Patients who are pre-treated with a total daily dose of exactly 900 or exactly 1200 mg or exactly 1500 mg oxcarbazepine (as OXC IR) will increase dosage of OXC by 300 mg to a daily dose of 1200 mg / 1500 mg / 1800 mg OXC IR (divided in two daily doses). Dosage will be titrated to a maximum tolerated total daily dose, maximally to 2700 mg in steps of 300 mg every 6th day.

Sponsors & Collaborators

  • FGK Clinical Research GmbH

    collaborator INDUSTRY

  • Desitin Arzneimittel GmbH

    lead INDUSTRY

Principal Investigators

  • Christian E. Elger, Prof. MD · Klinik für Epileptologie, Universität Bonn, Bonn, Germany

  • Martina Wangemann, Dr. · Desitin Arzneimittel GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • Germany

Study Locations

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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 NCT00391534 on ClinicalTrials.gov