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

UCB

Status and phase: Completed; Phase 1

Conditions: Epilepsy

Treatments: Drug: levetiracetam; Other: placebo; Drug: lorazepam; Drug: Brivaracetam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00736931

N01297

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

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

Treatment:

Drug: Brivaracetam

2

Active Comparator group

Description:

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

Treatment:

Drug: levetiracetam

3

Active Comparator group

Description:

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

Treatment:

Drug: lorazepam

4

Placebo Comparator group

Description:

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

Treatment:

Other: placebo