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

UCB

Status and phase: Completed; Phase 3

Conditions: Epilepsy

Treatments: Drug: Carbamazepine Controlled Release (CBZ-CR); Drug: Levetiracetam; Drug: Valproate Extended Release

Study type: Interventional

Funder types: Industry

Identifiers

NCT00175903

2004-001339-41 (EudraCT Number)

N01175

Details and patient eligibility

About

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.

Enrollment: 1,701 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,701 participants in 2 patient groups

Levetiracetam

Experimental group

Description:

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

Treatment:

Drug: Levetiracetam

Older Antepileptic Drugs

Active Comparator group

Description:

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

Treatment:

Drug: Carbamazepine Controlled Release (CBZ-CR)

Drug: Valproate Extended Release