Efficacy and Safety of Eslicarbazepine Acetate as adjunctive Therapy for refractory partial seizures in a double blind, randomized, placebo-controlled, parallel-group multicenter clinical trial

Description

This research study will examine the safety and efficacy of adding Eslicarbazepine Acetate to patients original anti epileptic regimin for those individuals whose seizure are not well controlled on their current therapy. It is a 2 part study with approximately 615 participants. Part I will follow a group with an 8 wk baseline period; a double-blind 2wk titration period; and a 12wk maintenance period. For those subjects willing there is an additional open label portion of the study that will allow the patient to participate for an additional year after part I.

Patient Inclusion Criteria:

• 16 + years of age.
• Documented diagnosis of epilepsy at least 12 mos prior to screen
• At least 4 partial-onset seizures in the prior 4 weeks
• Current treatment with 1 or 2 antiepileptic drugs (stable dose for 1 mo)

Patient Exclusion Criteria:

• Simple partial seizures w/no motor symptomology
• Primary generalized seizures
• Diagnosed progressive neurological disorder
• Seizures that occur to close together to accurately count
• History of status epilepticus or cluster seizures
• Seizures of non-epileptic origin
• Previous use of Eslicarbazepine
• Pregnant or nursing
• Other conditions, in the opinion of the investigator, may compromise the subjects ability to comply with the study protocol

Details