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Completed

NCT Number: NCT01175954

Cognitive and Behavioral Effects of Lacosamide

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Northeast Regional Epilepsy Group

Hackensack, New Jersey, 07601, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lacosamide

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Evan Fertig

Other

Collaborators

  • UCB Pharma

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Aug 5, 2010
Registry last updated
Sep 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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