Second-Line Treatment Choice for Epilepsy

• Status: Unknown status
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

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 Epilepsy Clinics Foundation (SEIN) to start the SLICE study. Adult patients with partial and/or tonic-clonic seizures, insufficiently responding to valproate, are recruited for this study. These patients are randomized to receive one of three other drugs. Patients wil initially use this drug next to valproate. Neurologists of more than 20 general hospitals en neurologists of SEIN are participating in this study.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dutch Epilepsy Clinics Foundation
• Treatments: Carbamazepine; Etiracetam; Lamotrigine; Levetiracetam

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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