A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice

Viatris

Status and phase

Completed

Phase 4

Conditions

Focal Epilepsy

Treatments

Drug: Gabapentin, Lamotrigine, Levetiracetam, Pregabalin, Oxcarbacepine, Tiagabine, Topiramate, Zonisamide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00855738

LICEO STUDY

A0081144

Details and patient eligibility

About

Assessment of the efficacy under daily clinical conditions of the new antiepileptic drugs (AEDs) gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine and topiramate, used as first-choice combination therapy (bitherapy) in patients with focal epilepsy.

Enrollment

111 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Aged 18 years or older.
Diagnosis of focal epilepsy.
Previous failure of one or more AEDs used in monotherapy.
Background treatment with an antiepileptic drug.
The investigator has considered that the patient must start treatment with some of the seven new AEDs in combination therapy: lamotrigine, levetiracetam, gabapentin, oxcarbazepine, pregabalin, tiagabine and/or topiramate.
History of seizures in the patient in the past 3 months.
The patient or legal guardian must be able to understand the characteristics of the study and fill in the seizure diaries.
Written informed consent.

Exclusion criteria

Inability to comply with the study requirements.
Diagnosis of generalized epilepsy or inability to establish if focal or generalized.
Presence of serious or uncontrolled systemic disease, serious psychiatric disease or progressive neurological disease.
History of alcoholism, drug addiction, or abuse of medicines in the past two years.
Psychogenic seizures in the two years prior to inclusion in the study.