Effects of Adjunctive Lacosamide on Mood States and Quality of Life (QOL) in Patients With Epilepsy
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Epilepsy |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 17 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2011 |
| End Date: | July 2014 |
The purpose of this study is to determine the effect of lacosamide on mood and quality of
life in people with epilepsy.
life in people with epilepsy.
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.
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.
Inclusion Criteria:
- At least 17 years old
- Have partial (focal) onset seizures that are not controlled with medication
- (LCM group only) LCM is being added to anti-epileptic drug regimen by treating
physician
Exclusion Criteria:
- Have taken LCM in the past.
- Change in anti-epileptic drugs or their doses in the past 28 days.
- Have participated in another drug research study in the past 3 months.
- Have had epilepsy brain surgery, or plan to have epilepsy surgery in the next four
months.
- Have a psychiatric or behavioral condition, which in the opinion of the investigator,
could compromise patient's ability to participate in the study.
- Have a progressive (worsening) disease that affects patients brain and its functions.
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SUNY Downstate Medical Center Formally known as The State University of New York Health Science...
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