Status:
COMPLETED
Cognitive and Behavioral Effects of Lacosamide
Lead Sponsor:
Evan Fertig
Collaborating Sponsors:
UCB Pharma
Conditions:
Epilepsy
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01175954
Start Date
May 1 2010
End Date
December 1 2015
Last Update
September 14 2017
Active Locations (1)
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1
Northeast Regional Epilepsy Group
Hackensack, New Jersey, United States, 07601