Clinical Study in Healthy Volunteers to Investigate the Neurocognitive Effects of a New Antiepileptic Drug: Brivaracetam

Study Overview
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Brief Summary
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The primary objective of the study is to evaluate the neurocognitive effects of brivaracetam

Official Title
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Randomized, Comparative, Double-blind, Placebo-controlled, Triple-dummy, Four-way Cross-over Study to Investigate Neurocognitive Effects of Brivaracetam in Healthy Subjects

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: Brivaracetam
* Drug: levetiracetam
* Drug: lorazepam
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female volunteer aged 18 to 50 years inclusive Body Mass Index (BMI) between 18.0 and 30.0 kg/m² inclusive Good physical and mental health status Blood pressure and heart rate within normal range Electrocardiogram and laboratory tests without clinically significant abnormality Exclusion Criteria: IQ ≤ 80 as determined by Test of non-verbal intelligence Center for Epidemiological Studies Depression (CES-D Scale ≥16, Known allergy/intolerance to pyrrolidinone derivatives Abnormalities on EEG recordings Pregnant, lactating women History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, neurological, psychiatric disorders Use of any hepatic enzyme-inducing drug

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo. | Drug: Brivaracetam<br>* Brivaracetam 10 mg tablets<br>|
| Active Comparator: 2<br>4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo. | Drug: levetiracetam<br>* 500mg tablets<br>|
| Active Comparator: 3<br>4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo. | Drug: lorazepam<br>* lorazepam 2 mg over encapsulated tablets<br>|
| Placebo Comparator: 4<br>4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo. | Other: placebo<br>* placebo capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary score from a Cognitive Neurophysiological Test (derived from electroencephalogram [EEG], event related potentials [ERP], and cognitive performance measures) |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Component subscores from the Cognitive Neurophysiological Test and scores from neuropsychological tests/assessments: SSEQ Subject Self Evaluation Questionnaire. SMDT Symbol Digit Modalities Test. COWA Controlled Oral Word Association. MCG Parag |  | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brivaracetam, Cognitive neurophysiological tests (CNT), Neuropsychological assessments