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

December 23, 2015 updated by: State University of New York - Downstate Medical Center
The purpose of this study is to determine the effect of lacosamide on mood and quality of life in people with epilepsy.

Study Overview

Status

Completed

Conditions

Detailed Description

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

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11203
        • SUNY downstate Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients being treated at epilepsy clinics at SUNY Downstate Medical Center

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
LCM group
Patients who are having lacosamide (LCM) added to their anti-epileptic drug regimen
control group
Patients who are NOT having lacosamide (LCM) added to their anti-epileptic drug regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in overall Quality of Life in Epilepsy-89 (QOLIE-89) score
Time Frame: baseline and 3 months later
baseline and 3 months later
Change from baseline in Profile of Mood States (POMS) score
Time Frame: baseline and 3 months later
baseline and 3 months later

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in QOLIE-89 subtests
Time Frame: baseline and 3 months later
baseline and 3 months later
Change from baseline in POMS subtests
Time Frame: baseline and 3 months later
baseline and 3 months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York - Downstate Medical Center

Collaborators

UCB Pharma

Investigators

  • Principal Investigator: Arthur C Grant, MD, PhD, State University of New York - Downstate Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

February 9, 2011

First Submitted That Met QC Criteria

February 15, 2011

First Posted (Estimate)

February 16, 2011

Study Record Updates

Last Update Posted (Estimate)

December 24, 2015

Last Update Submitted That Met QC Criteria

December 23, 2015

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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