Status:
COMPLETED
Clinical Study in Healthy Volunteers to Investigate the Neurocognitive Effects of a New Antiepileptic Drug: Brivaracetam
Lead Sponsor:
UCB Pharma
Conditions:
Epilepsy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The primary objective of the study is to evaluate the neurocognitive effects of brivaracetam
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00736931
Start Date
July 1 2008
End Date
October 1 2008
Last Update
May 28 2012
Active Locations (1)
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1
Overland Park, Kansas, United States