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

Primary Purpose

Epilepsy

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Brivaracetam

levetiracetam

lorazepam

placebo

About this trial

This is an interventional basic science trial for Epilepsy focused on measuring Brivaracetam, Cognitive neurophysiological tests (CNT), Neuropsychological assessments

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Arm Description

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

Outcomes

Primary Outcome Measures

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

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

Full Information

NCT ID

NCT00736931

First Posted

August 14, 2008

Last Updated

May 25, 2012

Sponsor

UCB Pharma

1. Study Identification

Unique Protocol Identification Number

NCT00736931

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2008

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UCB Pharma

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy

Keywords

Brivaracetam, Cognitive neurophysiological tests (CNT), Neuropsychological assessments

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Brivaracetam

Intervention Description

Brivaracetam 10 mg tablets

Intervention Type

Drug

Intervention Name(s)

levetiracetam

Intervention Description

500mg tablets

Intervention Type

Drug

Intervention Name(s)

lorazepam

Intervention Description

lorazepam 2 mg over encapsulated tablets

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

placebo capsules

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

UCB Clinical Trial Call Center

Organizational Affiliation

+1 877 822 9493 (UCB)

Official's Role

Study Director

Facility Information:

City

Overland Park

State/Province

Kansas

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20887370

Citation

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.

Results Reference

derived

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

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