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Completed

NCT Number: NCT00736931

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

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

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Overland Park, Kansas, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brivaracetam

Drug

Brivaracetam 10 mg tablets

Levetiracetam

Drug

500mg tablets

Lorazepam

Drug

lorazepam 2 mg over encapsulated tablets

Placebo

Other

placebo capsules

Primary outcomes

  1. Summary score from a Cognitive Neurophysiological Test (derived from electroencephalogram [EEG], event related potentials [ERP], and cognitive performance measures)

    Time frame: 3 weeks

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

Randomized, Comparative, Double-blind, Placebo-controlled, Triple-dummy, Four-way Cross-over Study to Investigate Neurocognitive Effects of Brivaracetam in Healthy Subjects

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Aug 18, 2008
Registry last updated
May 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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