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

Epilepsy Clinical Trial

Official title:

Randomized, Comparative, Double-blind, Placebo-controlled, Triple-dummy, Four-way Cross-over Study to Investigate Neurocognitive Effects of Brivaracetam in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736931
• Other study ID #: N01297
• Status: Completed
• Phase: Phase 1
• First received: August 14, 2008
• Last updated: May 25, 2012
• Start date: July 2008
• Est. completion date: October 2008

Study information

• Verified date: October 2008
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Brivaracetam
Brivaracetam 10 mg tablets
• levetiracetam
500mg tablets
• lorazepam
lorazepam 2 mg over encapsulated tablets

Other:
• placebo
placebo capsules

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Summary score from a Cognitive Neurophysiological Test (derived from electroencephalogram [EEG], event related potentials [ERP], and cognitive performance measures)		3 weeks	No
Secondary	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	No