Epilepsy Research

New Onset Seizures in the Elderly:

A Double-Blind, Randomized Study Comparing Levetiracetam and Carbamazepine in Elderly Patients with Partial Onset Seizures – Pilot Study sponsored by Epilepsy International

Summary of Main Inclusion Criteria
1. Have a clinical diagnosis of epilepsy characterized by partial onset seizures (CPS or SPS) with, or without, secondarily generalized tonic-clonic seizures.
2. Patients must be on a stable dose of a single AED or taking no AED.
3. Patients must have been diagnosed with epilepsy AND Had at least one (1) seizures in the six (6) months before enrollment and the primary treating physician feels switching to an alternate AED is clinically indicated OR the patient has not been previously treated with an AED for epilepsy.
4. Patients of either gender who are 60 years of age or older.

Summary of Main Exclusion Criteria
1. Patients who have clinically unstable disease: cardiovascular, hepatic, renal, gastrointestinal, pulmonary metabolic, endocrine or other systemic disease that could interfere with their participation in the study.
2. Patients with seizures occurring only in clusters.
3. Patients previously treated with levetiracetam or carbamazepine for epilepsy or discontinued treatment of either drug due to an adverse event.
4. Patients with psychiatric or medical causes for non-epileptic seizures or patients with significant psychiatric disease that might affect the outcome of the study.
5. Patients who have failed for efficacy reasons more than one AED, patients chronically taking any AED and/or patients implanted with a VNS will be excluded.

Rufinamide Given as Adjunctive Therapy for Seizures:

A Double-Blind, Placebo-Controlled, Parallel-Group Study of Rufinamide Given as Adjunctive Therapy in Patients with Refractory Partial Seizures-Phase III - Sponsored by Eisai

Summary of Main Inclusion Criteria
1. Patients of either gender between 12 and 80 years of age
2. Patients with a diagnosis of epilepsy with partial-onset seizures with or without secondarily generalized seizures that have at least six seizures in an eight week period. (Simple partial seizures without motor signs will not be counted).
3. Patients with non-controlled partial seizures despite having been treated with at least 2 different AEDs (given concurrently or sequentially) for at least two years.
4. Current treatment with a maximum of three licensed AEDs in patients known to take their medication(s) as directed. All AEDs must be at stable dose(s) for one month prior to screening.
5. Patients with a VNS can be included only if the device has been implanted for at least six months and stimulator parameters have not been changed within 1 month prior to screening.

Summary of Main Exclusion Criteria
1. Patients with non-motor simple partial seizures only.
2. Patients with generalized epilepsies or seizures, such as absences, myoclonic epilepsies, Lennox-Gastaut syndrome or patients with a history of status epilepticus or seizure clusters.
3. Patients with evidence of clinically significant disease (cardiac, respiratory, gastrointestinal, hepatic, hematologic, renal or psychiatric disease, etc) that may affect trial outcome.
4. Patients with any progressive central nervous system (CNS) disease, or progressive tumor.
5. Patients having psychogenic seizures in the previous year.
6. Patients treated with felbamate within two months prior to Visit 1 and patients treated with vigabatrin within five months prior to visit 1 will be excluded.

Brivaracetam Given as Adjunctive Therapy for Seizures:

An International, Double-Blind, Parallel-Group, Placebo-Controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (= 16 to 70 years old) with Partial Onset Seizures - Sponsored by UCB, Inc.

Summary of Main Inclusion Criteria
1. Patients of either gender between 16 and 70 years of age
2. Patients with well-characterized focal epilepsy or epileptic syndrome according to the ILAE classification.
3. Patients with a history of partial onset seizures whether or not secondarily generalized who are having at least 8 partial onset seizures during the 8 week Baseline Period.
4. Current treatment with 1-2 permitted concomitant AED(s). All AEDs must be at stable dose(s) for one month prior to screening.
5. Patients with a VNS can be included only if the device has been implanted for at least nine months and stimulator parameters have not been changed within 1 month prior to screening.

Summary of Main Exclusion Criteria
1. Patients with non-motor simple partial seizures only.
2. History or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before V3, as well as history or presence of pseudo-seizures.
3. History or presence of status epilepticus during the year preceding V1 or during baseline.
4. Subject taking any drug with possible relevant CNS effects except if stable from at least 1 month before Visit 1 and expected to be kept stable during the Treatment Period.
5. History of cerebrovascular accident (CVA), including transient ischemic attack (TIA), the last 6 months or presence of any sign suggestion rapidly progressing brain disorder or brain tumor.
6. Any clinical conditions which impair reliable participation in the trial or necessitate the use of medication not allowed by protocol.
7. Patients who are currently taking vigabatrin or felbamate, or who have taken these drugs in the past will be evaluated with additional exclusion criterion.