NCT01296880

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 16, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

December 24, 2015

Status Verified

June 1, 2012

Enrollment Period

3.1 years

First QC Date

February 9, 2011

Last Update Submit

December 23, 2015

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (2)

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

    baseline and 3 months later

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

    baseline and 3 months later

Secondary Outcomes (2)

  • Change from baseline in QOLIE-89 subtests

    baseline and 3 months later

  • Change from baseline in POMS subtests

    baseline and 3 months later

Study Arms (2)

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

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients being treated at epilepsy clinics at SUNY Downstate Medical Center

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Arthur C Grant, MD, PhD

    State University of New York - Downstate Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2011

First Posted

February 16, 2011

Study Start

June 1, 2011

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

December 24, 2015

Record last verified: 2012-06

Locations

US(1)