Status:
COMPLETED
A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Focal Epilepsy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 fi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT00855738
Start Date
May 1 2007
End Date
June 1 2009
Last Update
January 25 2021
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