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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00736931
Recruitment Status : Completed
First Posted : August 18, 2008
Last Update Posted : May 28, 2012
Information provided by (Responsible Party):
UCB Pharma

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

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Brivaracetam Drug: levetiracetam Drug: lorazepam Other: placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Study Start Date : July 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00736931

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United States, Kansas
Overland Park, Kansas, United States
Sponsors and Collaborators
UCB Pharma
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: UCB Pharma Identifier: NCT00736931    
Other Study ID Numbers: N01297
First Posted: August 18, 2008    Key Record Dates
Last Update Posted: May 28, 2012
Last Verified: October 2008
Keywords provided by UCB Pharma:
Cognitive neurophysiological tests (CNT)
Neuropsychological assessments
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Nootropic Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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