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

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: UCB Pharma
• Treatments: Brivaracetam; Etiracetam; Levetiracetam; Lorazepam; Piracetam

Criteria

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