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.

UCB Pharma0 sites1,701 target enrollmentFebruary 2005

ConditionsEpilepsy

InterventionsLevetiracetam Carbamazepine Controlled Release (CBZ-CR)Valproate Extended Release

DrugsLevetiracetam Carbamazepine Controlled Release (CBZ-CR)Valproate Extended Release

Overview

Phase: Phase 3
Intervention: Levetiracetam
Conditions: Epilepsy
Sponsor: UCB Pharma
Enrollment: 1701
Primary Endpoint: Time to withdrawal from study medication (starting at V1) as a measure of combined efficacy and safety
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2005

End Date

October 2007

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

UCB Pharma

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Levetiracetam

Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.

Intervention: Levetiracetam

Older Antepileptic Drugs

Older AEDs consist of CBZ-CR 200 mg and 400 mg and VPA-ER 300 mg and 500 mg.

Intervention: Carbamazepine Controlled Release (CBZ-CR)

Older Antepileptic Drugs

Older AEDs consist of CBZ-CR 200 mg and 400 mg and VPA-ER 300 mg and 500 mg.

Intervention: Valproate Extended Release

Outcomes

Primary Outcomes

Time to withdrawal from study medication (starting at V1) as a measure of combined efficacy and safety

Time Frame: Visit 1 to End of Study (approximately 52 weeks)

Secondary Outcomes

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))