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Cognitive and Behavioral Effects of Lacosamide

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01175954
Recruitment Status : Completed
First Posted : August 5, 2010
Last Update Posted : September 14, 2017
UCB Pharma
Information provided by (Responsible Party):
Evan Fertig, Northeast Regional Epilepsy Group

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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Lacosamide Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2010
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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 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

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01175954

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United States, New Jersey
Northeast Regional Epilepsy Group
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Evan Fertig
UCB Pharma
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Principal Investigator: Marcelo Lancman, MD Northeast Regional Epilepsy Group
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Evan Fertig, Director, Northeast Regional Epilepsy Group Identifier: NCT01175954    
Other Study ID Numbers: NEREG-002
First Posted: August 5, 2010    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017
Keywords provided by Evan Fertig, Northeast Regional Epilepsy Group:
Partial Epilepsy
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action