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

NCT00855738 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2021-01-25

Study results available
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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.

Conditions

  • Focal Epilepsy

Interventions

DRUG

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

Sponsors & Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-06-30
Completion
2009-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00855738 on ClinicalTrials.gov