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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00736931
• Date of registration: 14/08/2008
• Prospective Registration: No
• Primary sponsor: UCB Pharma
• Public title: Clinical Study in Healthy Volunteers to Investigate the Neurocognitive Effects of a New Antiepileptic Drug: Brivaracetam
• Scientific title: Randomized, Comparative, Double-blind, Placebo-controlled, Triple-dummy, Four-way Cross-over Study to Investigate Neurocognitive Effects of Brivaracetam in Healthy Subjects
• Date of first enrolment: July 2008
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00736931
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: UCB Clinical Trial Call Center
• Affiliation: [phone] (UCB)

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Epilepsy

Intervention(s)

Other: placebo

Drug: lorazepam

Drug: Brivaracetam

Drug: levetiracetam

Primary Outcome(s)

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

Secondary Outcome(s)

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]

Secondary ID(s)

N01297

Source(s) of Monetary Support

Please refer to primary and secondary sponsors