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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00736931

Enrollment

Registered

2008-08-18

Start date

2008-07-31

Completion date

2008-10-31

Last updated

2012-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

Brivaracetam, Cognitive neurophysiological tests (CNT), Neuropsychological assessments

Brief summary

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

Interventions

DRUGBrivaracetam

Brivaracetam 10 mg tablets

DRUGlevetiracetam

500mg tablets

DRUGlorazepam

lorazepam 2 mg over encapsulated tablets

OTHERplacebo

placebo capsules

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026