Cognitive and Behavioral Effects of Lacosamide

NCT01175954 | Completed Phase 4

• 1 other identifier: NEREG-002
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

Partial Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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).

  30 weeks

Secondary Outcomes (1)

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

  30 weeks

Study Arms (1)

Lacosamide Open-Label

EXPERIMENTAL

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

Interventions

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.

Also known as: Vimpat

Lacosamide Open-Label

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Evan Fertig: lead
• UCB Pharma: collaborator

Study Sites (1)

Northeast Regional Epilepsy Group

Hackensack, New Jersey, 07601, United States

Location

Related Publications (1)

• 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.

  PMID: 27315132 DERIVED

MeSH Terms

Conditions

Epilepsy; Epilepsies, Partial

Interventions

Lacosamide

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Study Officials

• Marcelo Lancman, MD

  Northeast Regional Epilepsy Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 9, 2010
• First Posted: August 5, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 14, 2017

Record last verified: 2017-09

Locations

US (1)