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Trial record 14 of 40 for:    CARBAMAZEPINE AND Valproic Acid

Second-Line Treatment Choice for Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00208520
Recruitment Status : Unknown
Verified September 2006 by Dutch Epilepsy Clinics Foundation.
Recruitment status was:  Active, not recruiting
First Posted : September 21, 2005
Last Update Posted : September 12, 2006
Information provided by:
Dutch Epilepsy Clinics Foundation

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 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 or disease Intervention/treatment Phase
Adults With Tonic Clonic Seizures and/or Partial Seizures Drug: Carbamazepine Drug: Lamotrigine Drug: Levetiracetam Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Second-Line Treatment Choice for Epilepsy
Study Start Date : July 2003
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Primary Outcome Measures :
  1. Percentage seizure free

Secondary Outcome Measures :
  1. adverse effects
  2. clinimetric epilepsy scales

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00208520

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

Additional Information:
Layout table for additonal information Identifier: NCT00208520    
Other Study ID Numbers: CMO 2002/183
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: September 12, 2006
Last Verified: September 2006
Keywords provided by Dutch Epilepsy Clinics Foundation:
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Nootropic Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Sodium Channel Blockers
Antimanic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers