Cognitive and Behavioral Effects of Lacosamide

September 12, 2017 updated by: Evan Fertig

Phase IV Study of Cognitive and Behavioral Effects of Lacosamide as Adjunctive Therapy in Patients With Partial Epilepsy

Primary Objective:

Null hypothesis: A 24-week trial of adjunctive Lacosamide does not produce a decline in cognitive, mood or quality of life measures.

To determine the cognitive and behavioral side effects of lacosamide in patients with partial epilepsy and follow them for a period of 24 weeks using a neuropsychological test battery drawing on tests commonly used and designed to maximize sensitivity to drug effects.

Secondary Objectives:

To determine if any significant changes in cognitive, mood or quality of life measures are dependent upon changes in seizure severity, neurotoxicity, adverse events, or Lacosamide dosage.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators will examine a group of patients with partial epilepsy (chronic seizures arising from one particular part of the brain) whose seizures have not been controlled. If they consent to the study, they will be followed for 4 weeks to get a baseline seizure frequency. The patients will take a battery of tests assessing attention, memory, cognitive speed, and language, and fill out some inventories to assess their mood and quality of life. They will then receive a new anti-epileptic drug, lacosamide, to add to whatever epilepsy medications they are currently taking. They will be closely followed for 24 weeks with regular doctor's visits to monitor their physical health and seizure control, and will complete an inventory assessing the frequency and severity of their seizures. During that period of time, the other medication will remain unchanged. At the end of the 24-week period they will re-take the battery of cognitive tests and mood and quality of life inventories. The cognitive, mood, and quality of life variables will be analyzed to determine if they change for the better or worse after the course of lacosamide treatment. Any changes will also be analyzed with respect to seizure frequency and severity and to adverse events or side effects from the addition of the lacosamide, as well as to lacosamide dosage. The investigators chose this design since it closely represents what the investigators do in clinical practice.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Northeast Regional Epilepsy Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects must meet all the following inclusion criteria to be eligible for enrollment into the trial

  • Age range 18-70
  • Able and willing to provide written informed consent to participate in the study in accordance with the ICH and GCP guidelines, and per the judgement of the investigator be able to cooperate fully with neuropsychological testing
  • Native English speaker or balanced bilingual
  • Diagnosis of refractory partial onset epilepsy
  • Historical mean seizure frequency of >/= 1 seizure per month on average during 6 months prior to Visit 1.

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the trial:

  • History of drug/alcohol abuse
  • Females who are pregnant or are on an unapproved method of contraception
  • Psychiatric disorder (Diagnosis of Bipolar Disorder, Schizophrenia, psychotic disorder , Major Depression requiring hospitalization in the past 2 years, or other psychological or behavioral condition which in the judgement of the investigator should exclude the subject from the study.
  • No active suicidal plan/intent or active suicidal thoughts in the last 6 months
  • Current use of antidepressant, anxiolytic, or antipsychotic agents
  • Presence of any progressive,demyelinating, or degenerative neurological condition
  • Diagnosis of psychogenic non-epileptic seizure disorder
  • Traumatic brain injury within 6 months of enrollment or TBI with suspected cognition/memory changes after TBI that has not stabilized 6 months prior to enrollment
  • Prior history of cardiac arrhythmia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lacosamide Open-Label
Lacosamide will be titrated starting from visit 1 for 2 weeks (50mg bid) and maintained at 100mg bid for the rest of the study period.
Drug: Lacosamide
Lacosamide will be titrated starting from visit 1 for 2 weeks (50mg bid) and maintained at 100mg bid for the rest of the study period. Dose Adjustments allowed up to 400 mg/day.
Other Names:
  • Vimpat
Drug: Lacosamide
Lacosamide will be titrated starting from visit 1 for 2 weeks (50mg bid) and maintained at 100mg bid for the rest of the study period.
Other Names:
  • Vimpat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Cognitive test scores
Time Frame: 30 weeks
Changes in the composite measure of the cognitive test scores and in the composite measure of the mood/Quality Of Life scores from baseline (visit 1) to scores recorded at termination (visit 4).
30 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship of Cognitive test scores with Seizure severity ,A-B Neurotoxicity,Adverse Events and Lacosamide Dosage
Time Frame: 30 weeks
The relationship of the cognitive and mood/Quality Of Life composite measures to seizure severity, A-B Neurotoxicity, Adverse Events, and Lacosamide dosage
30 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evan Fertig

Collaborators

UCB Pharma

Investigators

  • Principal Investigator: Marcelo Lancman, MD, Northeast Regional Epilepsy Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 9, 2010

First Submitted That Met QC Criteria

August 4, 2010

First Posted (Estimate)

August 5, 2010

Study Record Updates

Last Update Posted (Actual)

September 14, 2017

Last Update Submitted That Met QC Criteria

September 12, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEREG-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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