Status:
UNKNOWN
Second-Line Treatment Choice for Epilepsy
Lead Sponsor:
Dutch Epilepsy Clinics Foundation
Conditions:
Adults With Tonic Clonic Seizures and/or Partial Seizures
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Most patients are prescribed valproate as their first antiepileptic drug. It is unknown which is the best second-line drug when patients do not become seizure free on valproate. This has led the Dutch...
Detailed Description
The purpose of the project is to compare several antiepileptic drugs given to adult patients with epilepsy after they have not become seizure free on valproate as a first-line antiepileptic drug. The ...
Eligibility Criteria
Inclusion
- Adult patients with generalized tonic-clonic, complex partial and/or simple partial seizures. The seizures should be well-defined according to the International Classification of Epileptic Seizures (1). Therefore, an accurate history and adequate neurophysiological data should be present in each case in order to confirm the diagnosis.
- Patients on valproate monotherapy who are not seizure free at at the maximal dose they can tolerate.
- Patients should be able to understand the patient information concerning the study and be able to give informed consent.
Exclusion
- Patients who failed on VPA monotherapy because of other causes than lack of seizure control at a maximally tolerated dose (unable to tolerate the lowest maintenance dose of VPA, idiosyncratic reactions, non-compliance)
- Absence seizures or juvenile myoclonic epilepsy
- Acute or progressive neurological disorders
- Alcohol or other substance abuse
- History of severe psychiatric illness
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
June 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00208520
Start Date
July 1 2003
End Date
June 1 2007
Last Update
September 12 2006
Active Locations (1)
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1
Dutch Epilepsy Clinics Foundation
Zwolle, Netherlands, 8025 BV