Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed Epilepsy

This study has been completed.

Sponsor:

Information provided by:

UCB, Inc.

ClinicalTrials.gov Identifier:

NCT00175903

First received: September 9, 2005

Last updated: September 14, 2009

Last verified: September 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

September 14, 2009

Start Date ^ICMJE

February 2005

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

TIME TO WITHDRAWAL OF STUDY MEDICATION AS A COMBINED MEASURE OF EFFICACY AND SAFETY

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00175903 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

EFFICACY:RETENTION RATE; SEIZURE FREEDOM AT 6 AND 12 MONTHS; TIME TO FIRST SEIZURE.

Original Secondary Outcome Measures ^ICMJE

EFFICACY:
- RETENTION RATE
- SEIZURE FREEDOM AT 6 AND 12 MONTHS.
- TIME TO FIRST SEIZURE.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed Epilepsy

Official Title ^ICMJE

A Therapeutic Confirmatory, Open-label, Multi-center, Randomized 2 Parallel Groups, Community-based Trial Studying the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral Tablets 250-500 mg b.i.d.) Compared to Sodium Valproate (1000 to 2000 mg/Day Oral ER Tablets 300-500 mg b.i.d.) and Carbamazepine (600 to 1600 mg/Day Oral CR Tablets 200-400 mg b.i.d.) as Monotherapy in Subjects With Newly Diagnosed Epilepsy.

Brief Summary

Open label, multicenter, international, randomized, parallel group, phase IIIb study comparing the efficacy and safety of levetiracetam to two standard antiepileptic drugs (CBZ and VPA) in patients with newly diagnosed epilepsy in a clinical practice setting.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Epilepsy

Intervention ^ICMJE

Drug: LEVETIRACETAM (UCB)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1701

Completion Date

October 2007

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of epilepsy (all types of seizures) was made during the past year.
Subjects must have had at least two unprovoked seizures in the past 2 years with at least one during the last 6 months.
Female subjects without childbearing potential are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method.

Exclusion Criteria:

Subjects previously allocated to a trial treatment (CBZ, VPA and LEV) used in this trial.
Participation in another clinical trial with an investigational drug or device within 12 weeks of the selection visit (V1), or at any time during this trial.
Pregnant or lactating women.
Presence of known pseudoseizures within the last year.
Uncountable seizures (clusters) or history of convulsive status epilepticus.
Any disorder or condition that may interfere with the absorption, distribution, metabolisation or excretion of drugs.
History of suicide attempt, current suicidal ideation, or other serious psychiatric disorders requiring or having required hospitalization or medication within the previous five years.
Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors.
Presence of a terminal illness or any medical condition that might interfere with the subject's trial participation.

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Romania, Russian Federation, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00175903

Other Study ID Numbers ^ICMJE

N01175, EUDRACT NUMBER: 2004-001339-41

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

UCB, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

UCB Clinical Trial Call Center

UCB, Inc.

Information Provided By

UCB, Inc.

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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