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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-10-31

Brief Summary

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The primary objective of the study is to evaluate the neurocognitive effects of brivaracetam

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Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo.

Group Type EXPERIMENTAL

Brivaracetam

Intervention Type DRUG

Brivaracetam 10 mg tablets

2

4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo.

Group Type ACTIVE_COMPARATOR

levetiracetam

Intervention Type DRUG

500mg tablets

3

4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo.

Group Type ACTIVE_COMPARATOR

lorazepam

Intervention Type DRUG

lorazepam 2 mg over encapsulated tablets

4

4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

placebo capsules

Interventions

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Brivaracetam

Brivaracetam 10 mg tablets

Intervention Type DRUG

levetiracetam

500mg tablets

Intervention Type DRUG

lorazepam

lorazepam 2 mg over encapsulated tablets

Intervention Type DRUG

placebo

placebo capsules

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes