Trials / Completed
CompletedNCT03021018
A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting
A Multicenter, Open-Label, Randomized, Parallel-Group, Active-Controlled Study to Assess the Efficacy and Safety of Brivaracetam Administered Intravenously as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- UCB Biopharma S.P.R.L. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the efficacy of intravenous brivaracetam (BRV) compared to intravenous lorazepam (LZP) in subjects with epilepsy undergoing Epilepsy Monitoring Unit (EMU) evaluation who experience seizures that require prompt treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Brivaracetam | * Pharmaceutical Form: Solution for infusion * Concentration: 10 mg/ml * Route of Administration: intravenous |
| DRUG | Lorazepam | * Pharmaceutical Form: Solution for injection * Route of Administration: intravenous |
Timeline
- Start date
- 2017-02-06
- Primary completion
- 2018-04-27
- Completion
- 2018-04-27
- First posted
- 2017-01-13
- Last updated
- 2020-12-16
- Results posted
- 2019-05-28
Locations
14 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03021018. Inclusion in this directory is not an endorsement.