Effects of Adjunctive Lacosamide on Mood States and Quality of Life (QOL) in Patients With Epilepsy
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|ClinicalTrials.gov Identifier: NCT01296880|
Recruitment Status : Completed
First Posted : February 16, 2011
Last Update Posted : December 24, 2015
|Condition or disease|
Lacosamide (LCM) was found in phase 3 studies to have good efficacy and tolerability as adjunctive treatment in adult patients with uncontrolled partial onset seizures, with or without secondary generalization. Dose-related adverse drug reactions (ADRs) included dizziness, headache and nausea, but the incidence of reported mood symptoms was similar to placebo. The very low incidence of such events, combined with LCM's unique mechanism of action, suggest that LCM has the potential to be among the few anti-epileptic drugs (AEDs) without clinically significant mood ADRs.
The effects of LCM on mood states (i.e., worsening or improvement) have not been examined with standardized measures. In addition, its effects on quality of life (QOL) have not been explored, although QOL is known to be affected by other AEDs.
The investigators propose to examine the effects of LCM on mood and QOL in a real-world population of adult patients with partial-onset seizures. To the knowledge of the investigators, the proposed study will be the first to examine these domains in a scientifically rigorous fashion in patients treated with LCM. Thus, study results will fill a current knowledge gap, and will provide important information to clinicians and patients when considering LCM treatment.
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|Observational Model:||Case Control|
|Official Title:||Effects of Adjunctive Lacosamide on Mood States and Quality of Life (QOL) in Patients With Epilepsy|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Patients who are having lacosamide (LCM) added to their anti-epileptic drug regimen
Patients who are NOT having lacosamide (LCM) added to their anti-epileptic drug regimen
- Change from baseline in overall Quality of Life in Epilepsy-89 (QOLIE-89) score [ Time Frame: baseline and 3 months later ]
- Change from baseline in Profile of Mood States (POMS) score [ Time Frame: baseline and 3 months later ]
- Change from baseline in QOLIE-89 subtests [ Time Frame: baseline and 3 months later ]
- Change from baseline in POMS subtests [ Time Frame: baseline and 3 months later ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01296880
|United States, New York|
|SUNY Downstate Medical Center|
|Brooklyn, New York, United States, 11203|
|Principal Investigator:||Arthur C Grant, MD, PhD||State University of New York - Downstate Medical Center|