A Phase 4 interventional study of Lacosamide and Lacosamide in Epilepsy, sponsored by Evan Fertig. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-09-14.
Sponsored by Evan Fertig · Phase 4, Interventional, and Treatment
Primary Objective:
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.
Secondary Objectives:
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.
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.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 32 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →This is the only study on the registry with Evan Fertig as lead sponsor.
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Subjects must meet all the following inclusion criteria to be eligible for enrollment into the trial
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the trial:
Lacosamide will be titrated starting from visit 1 for 2 weeks (50mg bid) and maintained at 100mg bid for the rest of the study period.
Drug: Lacosamide
Lacosamide will be titrated starting from visit 1 for 2 weeks (50mg bid) and maintained at 100mg bid for the rest of the study period. Dose Adjustments allowed up to 400 mg/day.
Also known as: Vimpat
Lacosamide will be titrated starting from visit 1 for 2 weeks (50mg bid) and maintained at 100mg bid for the rest of the study period.
Also known as: Vimpat
Changes in Cognitive test scores
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).
Time frame: 30 weeks
Relationship of Cognitive test scores with Seizure severity ,A-B Neurotoxicity,Adverse Events and Lacosamide Dosage
The relationship of the cognitive and mood/Quality Of Life composite measures to seizure severity, A-B Neurotoxicity, Adverse Events, and Lacosamide dosage
Time frame: 30 weeks
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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