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Completed

NCT Number: NCT01296880

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

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

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

17 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change from baseline in overall Quality of Life in Epilepsy-89 (QOLIE-89) score

    Time frame: baseline and 3 months later

  2. Change from baseline in Profile of Mood States (POMS) score

    Time frame: baseline and 3 months later

Secondary outcomes

  1. Change from baseline in QOLIE-89 subtests

    Time frame: baseline and 3 months later

  2. Change from baseline in POMS subtests

    Time frame: baseline and 3 months later

Sponsors and collaborators

Lead sponsor

State University of New York - Downstate Medical Center

Other

Collaborators

  • UCB Pharma

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 16, 2011
Registry last updated
Dec 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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