Cognitive and Behavioral Effects of Lacosamide

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Northeast Regional Epilepsy Group
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Evan Fertig, Northeast Regional Epilepsy Group
ClinicalTrials.gov Identifier:
NCT01175954
First received: July 9, 2010
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Epilepsy
Drug: Lacosamide
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV Study of Cognitive and Behavioral Effects of Lacosamide as Adjunctive Therapy in Patients With Partial Epilepsy

Resource links provided by NLM:


Further study details as provided by Northeast Regional Epilepsy Group:

Primary Outcome Measures:
  • Changes in Cognitive test scores [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
    The relationship of the cognitive and mood/Quality Of Life composite measures to seizure severity, A-B Neurotoxicity, Adverse Events, and Lacosamide dosage


Estimated Enrollment: 32
Study Start Date: May 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Vimpat

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175954

Contacts
Contact: Marcelo Lancman, MD 201-343-6676 Marclanc@aol.com
Contact: Munazza Malik, MD 201-343-6676 ext 122 mmalik@epilepsygroup.com

Locations
United States, New Jersey
Northeast Regional Epilepsy Group Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Munazza Malik, MD    201-343-6676 ext 122    mmalik@epilepsygroup.com   
Contact: Shannon Brophy, RN    201-343-6676    sbrophy@epilepsygroup.com   
Principal Investigator: Marcelo Lancman, MD         
Sub-Investigator: Evan Fertig, MD         
Sponsors and Collaborators
Evan Fertig
UCB Pharma
Investigators
Principal Investigator: Marcelo Lancman, MD Northeast Regional Epilepsy Group
  More Information

No publications provided

Responsible Party: Evan Fertig, Director, Northeast Regional Epilepsy Group
ClinicalTrials.gov Identifier: NCT01175954     History of Changes
Other Study ID Numbers: NEREG-002
Study First Received: July 9, 2010
Last Updated: September 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northeast Regional Epilepsy Group:
Partial Epilepsy

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lacosamide
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014