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

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: Carbamazepine; Etiracetam; Levetiracetam; Piracetam; Valproic Acid

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