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

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

Overview[ - collapse ][ - ]

Purpose	The primary objective of the study is to evaluate the neurocognitive effects of brivaracetam
Condition	Epilepsy
Intervention	Drug: Brivaracetam Drug: levetiracetam Drug: lorazepam Other: placebo
Phase	Phase 1
Sponsor	UCB, Inc.
Responsible Party	UCB, Inc.
ClinicalTrials.gov Identifier	NCT00736931
First Received	August 14, 2008
Last Updated	May 25, 2012
Last verified	October 2008

Tracking Information[ + expand ][ + ]

First Received Date	August 14, 2008
Last Updated Date	May 25, 2012
Start Date	July 2008
Estimated Primary Completion Date	October 2008
Current Primary Outcome Measures	Summary score from a Cognitive Neurophysiological Test (derived from electroencephalogram [EEG], event related potentials [ERP], and cognitive performance measures) [Time Frame: 3 weeks] [Designated as safety issue: No]
Current Secondary Outcome Measures	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 [Time Frame: 3 weeks] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Clinical Study in Healthy Volunteers to Investigate the Neurocognitive Effects of a New Antiepileptic Drug: Brivaracetam
Official Title	Randomized, Comparative, Double-blind, Placebo-controlled, Triple-dummy, Four-way Cross-over Study to Investigate Neurocognitive Effects of Brivaracetam in Healthy Subjects
Brief Summary	The primary objective of the study is to evaluate the neurocognitive effects of brivaracetam
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Condition	Epilepsy
Intervention	Drug: Brivaracetam Brivaracetam 10 mg tablets Drug: levetiracetam 500mg tablets Drug: lorazepam lorazepam 2 mg over encapsulated tablets Other: placebo placebo capsules
Study Arm (s)	Experimental: 1 4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo. Active Comparator: 2 4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo. Active Comparator: 3 4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo. Placebo Comparator: 4 4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	20
Estimated Completion Date	October 2008
Estimated Primary Completion Date	October 2008
Eligibility 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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00736931
Other Study ID Numbers	N01297
Has Data Monitoring Committee	No
Information Provided By	UCB, Inc.
Study Sponsor	UCB, Inc.
Collaborators	Not Provided
Investigators	Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
Verification Date	October 2008

Locations[ + expand ][ + ]