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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01296880
• Other study ID #: 11-011
• Status: Completed
• Phase: N/A
• First received: February 9, 2011
• Last updated: December 23, 2015
• Start date: June 2011
• Est. completion date: July 2014

Study information

• Verified date: June 2012
• Source: State University of New York - Downstate Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Epilepsy

Locations

Country	Name	City	State
United States	SUNY Downstate Medical Center	Brooklyn	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York - Downstate Medical Center	UCB Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in overall Quality of Life in Epilepsy-89 (QOLIE-89) score		baseline and 3 months later	No
Primary	Change from baseline in Profile of Mood States (POMS) score		baseline and 3 months later	No
Secondary	Change from baseline in QOLIE-89 subtests		baseline and 3 months later	No
Secondary	Change from baseline in POMS subtests		baseline and 3 months later	No