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

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00736931

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 I

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Pharmacodynamics Study
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:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

Drug Information available for: Levetiracetam Brivaracetam Lorazepam

U.S. FDA Resources

Further study details as provided by UCB:

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
1: Experimental 4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo.	Drug: Brivaracetam Brivaracetam 10 mg tablets
2: Active Comparator 4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo.	Drug: levetiracetam 500mg tablets
3: Active Comparator 4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo.	Drug: lorazepam lorazepam 2 mg over encapsulated tablets
4: Placebo Comparator 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736931

Locations

United States, Kansas

Overland Park, Kansas, United States

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	N01297
Study First Received:	August 14, 2008
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00736931 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by UCB:

Brivaracetam
Cognitive neurophysiological tests (CNT)
Neuropsychological assessments

Study placed in the following topic categories:

Nootropic Agents
Neurotransmitter Agents
Tranquilizing Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Diseases
Central Nervous System Depressants
Healthy
Brain Diseases

Oxymetazoline
Lorazepam
Epilepsy
Phenylephrine
Hypnotics and Sedatives
Etiracetam
Anti-Anxiety Agents
Peripheral Nervous System Agents
Anticonvulsants

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Brain Diseases
Lorazepam
Therapeutic Uses
Hypnotics and Sedatives
Nootropic Agents
Tranquilizing Agents
Nervous System Diseases

Gastrointestinal Agents
Central Nervous System Depressants
Central Nervous System Diseases
Pharmacologic Actions
Epilepsy
Autonomic Agents
GABA Agents
Etiracetam
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on September 11, 2009