Official Title: “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.”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2007

Intervention(s) in this Clinical Trial

• Drug: LEVETIRACETAM (UCB)

Primary Measures

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

Secondary Measures

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

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

SONJA BUYLE, MD Study Director UCB  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00175903

Study ID Number: N01175

ClinicalTrials.gov Identifier: NCT00175903

Health Authority: Austria: Federal Ministry for Health and Women