Clinical trial NCT01296880: Effects of Adjunctive Lacosamide on Mood States and Quality of Life (QOL) in Patients With Epilepsy
Official title: Effects of Adjunctive Lacosamide on Mood States and Quality of Life (QOL) in Patients With Epilepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Lead sponsor: State University of New York - Downstate Medical Center
Sponsor class: OTHER
Collaborators: name: UCB Pharma
First posted: 2011-02-16
Enrollment: 60
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being treated at epilepsy clinics at SUNY Downstate Medical Center

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

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 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.

Primary outcomes:
measure: Change from baseline in overall Quality of Life in Epilepsy-89 (QOLIE-89) score
timeFrame: baseline and 3 months later
measure: Change from baseline in Profile of Mood States (POMS) score
timeFrame: baseline and 3 months later
Secondary outcomes:
measure: Change from baseline in QOLIE-89 subtests
timeFrame: baseline and 3 months later
measure: Change from baseline in POMS subtests
timeFrame: baseline and 3 months later
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
Study officials:
affiliation: State University of New York - Downstate Medical Center
name: Arthur C Grant, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: