NCT00736931

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 14, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

May 28, 2012

Status Verified

October 1, 2008

Enrollment Period

3 months

First QC Date

August 14, 2008

Last Update Submit

May 25, 2012

Conditions

Epilepsy

Keywords

BrivaracetamCognitive neurophysiological tests (CNT)Neuropsychological assessments

Outcome Measures

Primary Outcomes (1)

  • Summary score from a Cognitive Neurophysiological Test (derived from electroencephalogram [EEG], event related potentials [ERP], and cognitive performance measures)

    3 weeks

Secondary Outcomes (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

    3 weeks

Study Arms (4)

1

EXPERIMENTAL

4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo.

Drug: Brivaracetam

2

ACTIVE COMPARATOR

4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo.

Drug: levetiracetam

3

ACTIVE COMPARATOR

4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo.

Drug: lorazepam

4

PLACEBO COMPARATOR

4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo.

Other: placebo

Interventions

BrivaracetamDRUG

Brivaracetam 10 mg tablets

1
levetiracetamDRUG

500mg tablets

2
lorazepamDRUG

lorazepam 2 mg over encapsulated tablets

3
placeboOTHER

placebo capsules

4

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Overland Park, Kansas, United States

Location

Related Publications (1)

  • Meador KJ, Gevins A, Leese PT, Otoul C, Loring DW. Neurocognitive effects of brivaracetam, levetiracetam, and lorazepam. Epilepsia. 2011 Feb;52(2):264-72. doi: 10.1111/j.1528-1167.2010.02746.x. Epub 2010 Sep 30.

    PMID: 20887370DERIVED

MeSH Terms

Conditions

Epilepsy

Interventions

brivaracetamLevetiracetamLorazepam

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • UCB Clinical Trial Call Center

    +1 877 822 9493 (UCB)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2008

First Posted

August 18, 2008

Study Start

July 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

May 28, 2012

Record last verified: 2008-10

Locations

US(1)