Cognitive and Behavioral Effects of Lacosamide

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Evan Fertig
• Collaborator: UCB Pharma
• Treatments: Lacosamide

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