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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2009-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Focal Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1.0

Group Type OTHER

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

Intervention Type DRUG

* Gabapentin: up to 3.600 mg/d
* Lamotrigine: up to 400 mg/d
* Levetiracetam: up to 3.000 mg/d
* Pregabalin: up to 600 mg/d
* Oxcarbazepine: up to 2.400 mg/d
* Tiagabine: up to 30 mg/d
* Topiramate: up to 400 mg/d
* Zonisamide: up to 500 mg/d

Interventions

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

* Gabapentin: up to 3.600 mg/d
* Lamotrigine: up to 400 mg/d
* Levetiracetam: up to 3.000 mg/d
* Pregabalin: up to 600 mg/d
* Oxcarbazepine: up to 2.400 mg/d
* Tiagabine: up to 30 mg/d
* Topiramate: up to 400 mg/d
* Zonisamide: up to 500 mg/d

Intervention Type DRUG

Other Intervention Names

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Neurontin, Lamictal, Lyrica, Keppra, Topamax, Gabatril, Episen, Zonegran

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No