Second-Line Treatment Choice for Epilepsy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Dutch Epilepsy Clinics Foundation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Dutch Epilepsy Clinics Foundation
ClinicalTrials.gov Identifier:
NCT00208520
First received: September 13, 2005
Last updated: September 11, 2006
Last verified: September 2006
  Purpose

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.


Condition Intervention
Adults With Tonic Clonic Seizures and/or Partial Seizures
Drug: Carbamazepine
Drug: Lamotrigine
Drug: Levetiracetam

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Second-Line Treatment Choice for Epilepsy

Resource links provided by NLM:


Further study details as provided by Dutch Epilepsy Clinics Foundation:

Primary Outcome Measures:
  • Percentage seizure free

Secondary Outcome Measures:
  • adverse effects
  • clinimetric epilepsy scales

Estimated Enrollment: 60
Study Start Date: July 2003
Estimated Study Completion Date: June 2007
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 drugs will first be evaluated in combination with valproate and in case of success (being a seizure reduction of more than 50%) will also be evaluated in monotherapy.

Patients who did not become seizure free on valproate will be identified by neurologists in the participating hospitals. When these patients are willing to participate, they are randomized to one of three drugs: carbamazepine, lamotrigine and levetiracetam. In phase 1 of the project they keep on using valproate. The randomized second-line drugs will be titrated to a first dose level and the effectiveness of the combinations will be evaluated. When seizures persist and adverse effects allow it, the add-on drug is titrated to a second dose level and again the effectiveness of the combination is evaluated. When seizures still continue and adverse effects allow it, the add-on drug is titrated to a third and final dose level. When a patient does not become seizure free on a combination on that final level or adverse effects have prevented a dose increase to a higher level, that combination has failed in phase 1. When the patients does become seizure free on his or her combination, the combination is deemed a success for that patient. A patient will proceed to phase 2, when he or she has at least experienced a 50% seizure reduction.

In phase 2 of the project the second-line drug will be given in monotherapy. This means that valproate will be withdrawn. The dose of the second drug will be increased accordingly. The effectiveness of the drugs in monotherapy will be evaluated. The combined results of phase 1 and 2 will enable us to interpret the results. When all patients who became seizure free on a combination in phase 1, stay seizure free in phase 2, the efficacy of the combination should be attributed to the add-on drug. When these patients all develop seizures again, the efficacy of the combination should be attributed to the combination.

The primary outcome measure is percentage seizure free. Secondary outcome measures are adverse effects and the results of clinimetric epilepsy scales. Serum levels will be measured during the project. The projected sample size for each group has been lowered from 75 patients per group to 20 patients per group.

At this moment, neurologists of about 20 general hospitals are collaborating in this project. Inclusion of patients will continue until June 2006. The follow-up of patients and analysis of results will be carried until the projected end of the project.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208520

Locations
Netherlands
Dutch Epilepsy Clinics Foundation
Zwolle, Netherlands, 8025 BV
Sponsors and Collaborators
Dutch Epilepsy Clinics Foundation
Investigators
Principal Investigator: Charles L Deckers, MD, PhD Dutch Epilepsy Clinics Foundation
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00208520     History of Changes
Other Study ID Numbers: CMO 2002/183
Study First Received: September 13, 2005
Last Updated: September 11, 2006
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Dutch Epilepsy Clinics Foundation:
Epilepsy
Valproate
Levetiracetam
Lamotrigine
Carbamazepine

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Etiracetam
Lamotrigine
Carbamazepine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Nootropic Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents

ClinicalTrials.gov processed this record on August 28, 2014