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

This study has been completed.
Information provided by (Responsible Party):
UCB Pharma Identifier:
First received: August 14, 2008
Last updated: May 25, 2012
Last verified: October 2008
The primary objective of the study is to evaluate the neurocognitive effects of brivaracetam

Condition Intervention Phase
Epilepsy Drug: Brivaracetam Drug: levetiracetam Drug: lorazepam Other: placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Randomized, Comparative, Double-blind, Placebo-controlled, Triple-dummy, Four-way Cross-over Study to Investigate Neurocognitive Effects of Brivaracetam in Healthy Subjects

Resource links provided by NLM:

Further study details as provided by UCB Pharma:

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 ]

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 ]

Enrollment: 20
Study Start Date: July 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo.
Drug: Brivaracetam
Brivaracetam 10 mg tablets
Active Comparator: 2
4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo.
Drug: levetiracetam
500mg tablets
Active Comparator: 3
4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo.
Drug: lorazepam
lorazepam 2 mg over encapsulated tablets
Placebo Comparator: 4
4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo.
Other: placebo
placebo capsules


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00736931

United States, Kansas
Overland Park, Kansas, United States
Sponsors and Collaborators
UCB Pharma
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: UCB Pharma Identifier: NCT00736931     History of Changes
Other Study ID Numbers: N01297
Study First Received: August 14, 2008
Last Updated: May 25, 2012

Keywords provided by UCB Pharma:
Cognitive neurophysiological tests (CNT)
Neuropsychological assessments

Additional relevant MeSH terms:
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on August 18, 2017