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The primary objective of the study is to evaluate the neurocognitive effects of brivaracetam
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo. |
|
| 2 | Active Comparator | 4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo. |
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| 3 | Active Comparator | 4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo. |
|
| 4 | Placebo Comparator | 4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brivaracetam | Drug | Brivaracetam 10 mg tablets |
| |
| levetiracetam |
| Measure | Description | Time Frame |
|---|---|---|
| Summary score from a Cognitive Neurophysiological Test (derived from electroencephalogram [EEG], event related potentials [ERP], and cognitive performance measures) | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Overland Park | Kansas | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20887370 | Derived | 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. |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C482793 | brivaracetam |
| D000077287 | Levetiracetam |
| D008140 | Lorazepam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Drug |
500mg tablets |
|
| lorazepam | Drug | lorazepam 2 mg over encapsulated tablets |
|
| placebo | Other | placebo capsules |
|
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |