Trials / Completed
CompletedNCT03405714
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy
A Multicenter, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month < 16 Years of Age With Epilepsy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- UCB Biopharma S.P.R.L. · Industry
- Sex
- All
- Age
- 1 Month – 16 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of brivaracetam (BRV) administered intravenously (iv) in subjects \>= 1 month to \< 16 years of age with epilepsy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Brivaracetam | * Pharmaceutical form: Solution for iv injection * Route of administration: intravenous use * Concentration: 10 mg/ml |
Timeline
- Start date
- 2018-06-01
- Primary completion
- 2020-11-04
- Completion
- 2020-11-04
- First posted
- 2018-01-23
- Last updated
- 2022-05-11
- Results posted
- 2021-11-26
Locations
17 sites across 7 countries: United States, Czechia, Germany, Hungary, Italy, Mexico, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03405714. Inclusion in this directory is not an endorsement.