Effects of Adjunctive Lacosamide on Mood States and Quali... | NCT01296880

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

NCT01296880

Sponsor

State University of New York - Downstate Medical Center

Status

Completed

Last Update Posted

Dec 24, 2015Estimated

Enrollment

60Actual

Phase

Not provided

Conditions

Epilepsy

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Feb 9, 2011

First Submission Date that Met QC Criteria

Feb 15, 2011

First Posted Date

Feb 16, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 23, 2015

Last Update Posted Date

Dec 24, 2015Estimated

Name	Class
UCB Pharma	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Change from baseline in QOLIE-89 subtests		baseline and 3 months later
Change from baseline in POMS subtests		baseline and 3 months later

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients being treated at epilepsy clinics at SUNY Downstate Medical Center

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arthur C Grant, MD, PhD	State University of New York - Downstate Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SUNY Downstate Medical Center		Brooklyn	New York	11203	United States

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

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