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

Phase 1

Completed

• Conditions: Epilepsy
• Interventions: Drug: Brivaracetam; Drug: levetiracetam; Other: placebo; Drug: lorazepam

• Registration Number: NCT00736931
• Lead Sponsor: UCB Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-08-14
• Study First Submitted QC: 2008-08-15
• Study First Posted: 2008-08-18
• Status Verified: 2008-10
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Last Update Submitted: 2012-05-25
• Last Update Posted: 2012-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Brivaracetam	4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo.
2	levetiracetam	4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo.
4	placebo	4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo.
3	lorazepam	4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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