drugset / Trial / NCT01175954

Cognitive and Behavioral Effects of Lacosamide

NCT01175954

Phase 4 Completed 32 enrolled Evan Fertig UCB Pharma · collab
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2010-05
Primary completion
2015-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Lacosamide Other / unclassified 100 mg

Indications