Effects of Adjunctive Lacosamide on Mood States and Quality of Life (QOL) in Patients With Epilepsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2014-07-31

Brief Summary

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The purpose of this study is to determine the effect of lacosamide on mood and quality of life in people with epilepsy.

Detailed Description

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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.

Conditions

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Epilepsy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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LCM group

Patients who are having lacosamide (LCM) added to their anti-epileptic drug regimen

No interventions assigned to this group

control group

Patients who are NOT having lacosamide (LCM) added to their anti-epileptic drug regimen

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arthur C Grant, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

State University of New York - Downstate Medical Center

Locations

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SUNY Downstate Medical Center

Brooklyn, New York, United States

Site Status

Countries

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United States

Other Identifiers

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11-011

Identifier Type: -

Identifier Source: org_study_id