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Cognitive and Behavioral Effects of Lacosamide

Primary Purpose

Epilepsy

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Lacosamide

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Partial Epilepsy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Northeast Regional Epilepsy Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lacosamide Open-Label

Arm Description

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.

Outcomes

Primary Outcome Measures

Changes in Cognitive test scores

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).

Secondary Outcome Measures

Relationship of Cognitive test scores with Seizure severity ,A-B Neurotoxicity,Adverse Events and Lacosamide Dosage

The relationship of the cognitive and mood/Quality Of Life composite measures to seizure severity, A-B Neurotoxicity, Adverse Events, and Lacosamide dosage

Full Information

NCT ID

NCT01175954

First Posted

July 9, 2010

Last Updated

September 12, 2017

Sponsor

Evan Fertig

Collaborators

UCB Pharma

1. Study Identification

Unique Protocol Identification Number

NCT01175954

Brief Title

Cognitive and Behavioral Effects of Lacosamide

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

May 2010 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Evan Fertig

Collaborators

UCB Pharma

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy

Keywords

Partial Epilepsy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lacosamide Open-Label

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Lacosamide

Other Intervention Name(s)

Vimpat

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Lacosamide

Other Intervention Name(s)

Vimpat

Intervention Description

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.

Primary Outcome Measure Information:

Title

Changes in Cognitive test scores

Description

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).

Time Frame

30 weeks

Secondary Outcome Measure Information:

Title

Relationship of Cognitive test scores with Seizure severity ,A-B Neurotoxicity,Adverse Events and Lacosamide Dosage

Description

The relationship of the cognitive and mood/Quality Of Life composite measures to seizure severity, A-B Neurotoxicity, Adverse Events, and Lacosamide dosage

Time Frame

30 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marcelo Lancman, MD

Organizational Affiliation

Northeast Regional Epilepsy Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northeast Regional Epilepsy Group

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

27315132

Citation

Lancman ME, Fertig EJ, Trobliger RW, Perrine K, Myers L, Iyengar SS, Malik M. The effects of lacosamide on cognition, quality-of-life measures, and quality of life in patients with refractory partial epilepsy. Epilepsy Behav. 2016 Aug;61:27-33. doi: 10.1016/j.yebeh.2016.04.049. Epub 2016 Jun 14.

Results Reference

derived

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Cognitive and Behavioral Effects of Lacosamide

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