Monotherapy With Levetiracetam in Newly Diagnosed Patients Suffering From Epilepsy

November 25, 2013 updated by: UCB Pharma

A Multicenter, Double-blind, Randomized, Parallel Group, Positive-controlled Trial Comparing the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral b.i.d.) to Carbamazepine (400 to 1200 mg/Day Oral b.i.d.), Used as Monotherapy for up to a Maximum of 121 Weeks in Subjects (≥ 16 Years) Newly or Recently Diagnosed as Suffering From Epilepsy, and Experiencing Partial or Generalized Tonic-clonic Seizures

A double-blind trial comparing the efficacy and safety of levetiracetam to carbamazepine used as monotherapy in subjects (≥ 16 years) newly or recently diagnosed as suffering from epilepsy, and experiencing partial or generalized tonic-clonic seizures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

580

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with newly or recently diagnosed epilepsy having experienced unprovoked partial seizures (IA, IB, IC with clear focal origin), or generalized tonic-clonic seizures (without clear focal origin), that are classifiable according to the International Classification of Epileptic Seizures. The discrimination between IC and IIE is not requested for inclusion.
  • Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year preceding randomization out of which at least 1 unprovoked seizure in the 3 months preceding randomization.
  • Subjects with a confirmed diagnosis of epilepsy.
  • Male/female subjects (≥16 years).

Exclusion Criteria:

  • History or presence of seizures of other types than partial (IA, IB, IC, with clear focal origin) and generalized tonic-clonic (without clear focal origin) seizures.
  • History or presence of seizures occurring only in clustered patterns, defined as repeated seizures occurring over a short period of time, i.e. < 20 minutes, with or without function regained between 2 ictal events.
  • History, clinical or EEG finding suggestive of idiopathic generalized epilepsy (IGE) at randomization.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To demonstrate that levetiracetam monotherapy is not inferior to carbamazepine by measuring the proportion of subjects with 6-month seizure freedom in subjects newly diagnosed as suffering from epilepsy.

Secondary Outcome Measures

Outcome Measure
Proportion of subjects with one year seizure freedom; time to first seizure; safety.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (ACTUAL)

July 1, 2005

Study Completion (ACTUAL)

July 1, 2005

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (ESTIMATE)

September 8, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

November 26, 2013

Last Update Submitted That Met QC Criteria

November 25, 2013

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N01061

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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