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Study on the Treatment of Elderly Patients With Older and Newer Antiepileptic Drugs

NCT00438451 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 361

Last updated 2013-02-28

Study results available
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Summary

In this clinical trial patients with newly diagnosed focal epilepsy aged 60 years or older receive three different antiepileptic drugs in a double-blind, randomized design over a period of 58 weeks. All drugs are licensed for the treatment of epilepsy. The primary endpoint of this study will be retention rate at 58-weeks, since it reflects both efficacy and tolerability.

Conditions

  • Focal Epilepsy

Interventions

DRUG

Levetiracetam

LEV 250 mg capusles: week 1 and 2 0-0-1, week 3 and 4 1-0-1, week 5: 1-0-2, week 6: 2-0-2. Patients may take 2 to 12 per day (500 - 3000 mg)during maintenance.

DRUG

Carbamazepine

CBZ 100 mg capusles: week 1 and 2: 0-0-1, week 3 and 4: 1-0-1, week 5: 1-0-2, week 6: 2-0-2. Patients may take 2 to 12 per day (200 - 1200 mg) during maintenance depending on tolerance and efficacy.

DRUG

Lamotrigine

LTG 25 mg encapsulated: week 1 and 2: 0-0-1, week 3 and 4: 1-0-1, week 5: 1-0-2, week 6: 2-0-2. Patients may take 2 to 12 caps. per day (50 - 300 mg)during maintenance depending on tolerance and efficacy.

Sponsors & Collaborators

  • UCB Pharma GmbH

    collaborator INDUSTRY

  • Johannes Gutenberg University Mainz

    lead OTHER

Principal Investigators

  • Konrad J Werhahn, MD · Johannes Gutenberg University, Department od Neurology

  • Günter Kraemer, MD · Swiss Epilepy Centre

  • Eugen Trinka, MD · Medical University of Salzburg, Department of Neurology, Austria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2010-07-31
Completion
2011-08-31

Countries

  • Germany

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 NCT00438451 on ClinicalTrials.gov