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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by State University of New York - Downstate Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
UCB, Inc.
Information provided by (Responsible Party):
State University of New York - Downstate Medical Center
ClinicalTrials.gov Identifier:
NCT01296880
First received: February 9, 2011
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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


Condition
Epilepsy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effects of Adjunctive Lacosamide on Mood States and Quality of Life (QOL) in Patients With Epilepsy

Resource links provided by NLM:


Further study details as provided by State University of New York - Downstate Medical Center:

Primary Outcome Measures:
  • Change from baseline in overall QOLIE-89 score [ Time Frame: baseline and 3 months later ] [ Designated as safety issue: No ]
  • Change from baseline in Profile of Mood States (POMS) score [ Time Frame: baseline and 3 months later ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in QOLIE-89 subtests [ Time Frame: baseline and 3 months later ] [ Designated as safety issue: No ]
  • Change from baseline in POMS subtests [ Time Frame: baseline and 3 months later ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2011
Estimated Study Completion Date: January 2013
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients being treated at epilepsy clinics at SUNY Downstate Medical Center

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01296880

Locations
United States, New York
SUNY Downstate Medical Center Recruiting
Brooklyn, New York, United States, 11203
Contact: Arthur Grant, MD, PhD    718-270-2959    arthur.grant@downstate.edu   
Contact: Luba Nakhutina, PhD    718-270-2959    luba.nakhutina@downstate.edu   
Principal Investigator: Arthur Grant, MD, PhD         
Principal Investigator: Luba Nakhutina, PhD         
Sub-Investigator: Vanessa Arnedo, MS         
Sponsors and Collaborators
State University of New York - Downstate Medical Center
UCB, Inc.
Investigators
Principal Investigator: Arthur C Grant, MD, PhD State University of New York - Downstate Medical Center
  More Information

No publications provided

Responsible Party: State University of New York - Downstate Medical Center
ClinicalTrials.gov Identifier: NCT01296880     History of Changes
Other Study ID Numbers: 11-011
Study First Received: February 9, 2011
Last Updated: June 6, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 22, 2014