Clinical Trial Details
Braintumor Website

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NCT01175954 : Cognitive and Behavioral Effects of Lacosamide
PhasePhase 4
AgesMin: 18 Years Max: 70 Years
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

- Prior history of cardiac arrhythmia
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