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

Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: Brivaracetam (Drug); levetiracetam (Drug); lorazepam (Drug); placebo (Other)

Phase: Phase 1

Status: Completed

Sponsored by: UCB Pharma

Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493 (UCB)

Summary

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

Clinical Details

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

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

Secondary outcome: 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

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

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

Locations and Contacts

Overland Park, Kansas, United States
Additional Information

Starting date: July 2008
Last updated: May 25, 2012

Page last updated: August 23, 2015

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