Cognitive and Behavioral Effects of Lacosamide
Null hypothesis: A 24-week trial of adjunctive Lacosamide does not produce a decline in cognitive, mood or quality of life measures.
To determine the cognitive and behavioral side effects of lacosamide in patients with partial epilepsy and follow them for a period of 24 weeks using a neuropsychological test battery drawing on tests commonly used and designed to maximize sensitivity to drug effects.
To determine if any significant changes in cognitive, mood or quality of life measures are dependent upon changes in seizure severity, neurotoxicity, adverse events, or Lacosamide dosage.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase IV Study of Cognitive and Behavioral Effects of Lacosamide as Adjunctive Therapy in Patients With Partial Epilepsy|
- Changes in Cognitive test scores [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]Changes in the composite measure of the cognitive test scores and in the composite measure of the mood/Quality Of Life scores from baseline (visit 1) to scores recorded at termination (visit 4).
- Relationship of Cognitive test scores with Seizure severity ,A-B Neurotoxicity,Adverse Events and Lacosamide Dosage [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]The relationship of the cognitive and mood/Quality Of Life composite measures to seizure severity, A-B Neurotoxicity, Adverse Events, and Lacosamide dosage
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||June 2012|
|Estimated Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
The investigators will examine a group of patients with partial epilepsy (chronic seizures arising from one particular part of the brain) whose seizures have not been controlled. If they consent to the study, they will be followed for 4 weeks to get a baseline seizure frequency. The patients will take a battery of tests assessing attention, memory, cognitive speed, and language, and fill out some inventories to assess their mood and quality of life. They will then receive a new anti-epileptic drug, lacosamide, to add to whatever epilepsy medications they are currently taking. They will be closely followed for 24 weeks with regular doctor's visits to monitor their physical health and seizure control, and will complete an inventory assessing the frequency and severity of their seizures. During that period of time, the other medication will remain unchanged. At the end of the 24-week period they will re-take the battery of cognitive tests and mood and quality of life inventories. The cognitive, mood, and quality of life variables will be analyzed to determine if they change for the better or worse after the course of lacosamide treatment. Any changes will also be analyzed with respect to seizure frequency and severity and to adverse events or side effects from the addition of the lacosamide, as well as to lacosamide dosage. The investigators chose this design since it closely represents what the investigators do in clinical practice.
|Contact: Marcelo Lancman, MD||201-343-6676||Marclanc@aol.com|
|Contact: Sarah Henry, MPHemail@example.com|
|United States, New Jersey|
|Northeast Regional Epilepsy Group||Recruiting|
|Hackensack, New Jersey, United States, 07601|
|Contact: Sarah Henry, MPH 201-343-6676 firstname.lastname@example.org|
|Contact: Shannon Brophy, RN 201-343-6676 email@example.com|
|Principal Investigator: Marcelo Lancman, MD|
|Sub-Investigator: Georges Ghacibeh, MD|
|Sub-Investigator: Evan Fertig, MD|
|Principal Investigator:||Marcelo Lancman, MD||Northeast Regional Epilepsy Group|