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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Anticonvulsants; Etiracetam; Gabapentin; Lamotrigine; Levetiracetam; Pregabalin; Tiagabine; Topiramate; Zonisamide

Criteria

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.