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

Phase 3

Completed

• Conditions: Epilepsy
• Interventions: Drug: Carbamazepine Controlled Release (CBZ-CR); Drug: Levetiracetam; Drug: Valproate Extended Release

• Registration Number: NCT00175903
• Lead Sponsor: UCB Pharma

Brief Summary

Study N01175 was to compare overall effectiveness (efficacy and safety) of levetiracetam (LEV) versus the 2 older antiepileptic drugs (AEDs), sodium valproate extended release (VPA-ER) and carbamazepine controlled release (CBZ-CR) in the treatment of subjects with newly diagnosed epilepsy.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-12
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1701

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Older Antepileptic Drugs	Valproate Extended Release	Older AEDs consist of CBZ-CR 200 mg and 400 mg and VPA-ER 300 mg and 500 mg.
Older Antepileptic Drugs	Carbamazepine Controlled Release (CBZ-CR)	Older AEDs consist of CBZ-CR 200 mg and 400 mg and VPA-ER 300 mg and 500 mg.
Levetiracetam	Levetiracetam	Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.

Primary Outcome Measures

Name	Time	Method
Time to withdrawal from study medication (starting at V1) as a measure of combined efficacy and safety	Visit 1 to End of Study (approximately 52 weeks)

Secondary Outcome Measures

Name	Time	Method
Time to first seizure comparing Levetiracetam versus older Antiepileptic Drugs	Visit 1 to End of Study (approximately 52 weeks)
The retention rate after 6 months comparing Levetiracetam versus the older Antiepileptic Drugs	Visit 1 to Visit 4 (approximately 26 weeks)
The retention rate after 12 months comparing Levetiracetam versus the older Antiepileptic Drugs	Visit 1 to Visit 5 (approximately 52 weeks)
Seizure freedom at 12 months comparing Levetiracetam versus older Antiepileptic Drugs based on based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release	Visit 1 to Visit 5 (approximately 52 weeks)
Seizure freedom at 12 months comparing Levetiracetam versus older Antiepileptic Drugs	Visit 1 to Visit 5 (approximately 52 weeks)
Time to first seizure comparing Levetiracetam versus older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release	Visit 1 to End of Study (approximately 52 weeks)
The time to withdrawal comparing Levetiracetam versus the older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release	Visit 1 to End of Study (approximately 52 weeks)
The retention rate after 6 months comparing Levetiracetam versus older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release	Visit 1 to Visit 4 (approximately 26 weeks)
The retention rate after 12 months comparing Levetiracetam versus older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release	Visit 1 to Visit 5 (approximately 52 weeks)
Seizure freedom at 6 months comparing Levetiracetam versus older Antiepileptic Drugs	Visit 1 to Visit 4 (approximately 26 weeks)
Seizure freedom at 6 months comparing Levetiracetam versus older Antiepileptic Drugs based on based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release	Visit 1 to Visit 4 (approximately 26 weeks)