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
  Purpose

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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  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 ClinicalTrials.gov identifier: NCT00736931

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

No publications provided by UCB Pharma

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00736931     History of Changes
Other Study ID Numbers: N01297
Study First Received: August 14, 2008
Last Updated: May 25, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Etiracetam
Lorazepam
Anti-Anxiety Agents
Anticonvulsants
Antiemetics
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Gastrointestinal Agents
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nootropic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 21, 2014