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

Last updated on February 20, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Focal Epilepsy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT00855738
Pfizer
Completed
A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice

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[email protected]

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