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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00736931
First received: August 14, 2008
Last updated: May 25, 2012
Last verified: October 2008

August 14, 2008
May 25, 2012
July 2008
October 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00736931 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Clinical Study in Healthy Volunteers to Investigate the Neurocognitive Effects of a New Antiepileptic Drug: Brivaracetam
Randomized, Comparative, Double-blind, Placebo-controlled, Triple-dummy, Four-way Cross-over Study to Investigate Neurocognitive Effects of Brivaracetam in Healthy Subjects

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Epilepsy
  • Drug: Brivaracetam
    Brivaracetam 10 mg tablets
  • Drug: levetiracetam
    500mg tablets
  • Drug: lorazepam
    lorazepam 2 mg over encapsulated tablets
  • Other: placebo
    placebo capsules
  • Experimental: 1
    4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo.
    Intervention: Drug: Brivaracetam
  • Active Comparator: 2
    4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo.
    Intervention: Drug: levetiracetam
  • Active Comparator: 3
    4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo.
    Intervention: Drug: lorazepam
  • Placebo Comparator: 4
    4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo.
    Intervention: Other: placebo
Meador KJ, Gevins A, Leese PT, Otoul C, Loring DW. Neurocognitive effects of brivaracetam, levetiracetam, and lorazepam. Epilepsia. 2011 Feb;52(2):264-72. Epub 2010 Sep 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00736931
N01297
No
UCB Pharma
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP