Trials / Completed
CompletedNCT02710890
Study to Investigate Safety and Tolerability of Intravenous Lacosamide in Children.
A Multicenter, Open-Label Study to Investigate the Safety and Tolerability of Intravenous Lacosamide in Children (>= 1 Month to < 17 Years of Age) With Epilepsy
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 103 (actual)
- Sponsor
- UCB BIOSCIENCES, Inc. · Industry
- Sex
- All
- Age
- 1 Month – 16 Years
- Healthy volunteers
- Not accepted
Summary
EP0060 is a multicenter, open-label study to evaluate the safety and tolerability of intravenous (iv) Lacosamide (LCM) in pediatric subjects \>= 1 month to \< 17 years of age with epilepsy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lacosamide | Pharmaceutical form: solution for infusion Concentration: 10 mg/ml Route of Administration: intravenous |
Timeline
- Start date
- 2017-05-30
- Primary completion
- 2019-06-28
- Completion
- 2019-06-28
- First posted
- 2016-03-17
- Last updated
- 2023-02-23
- Results posted
- 2020-07-15
Locations
23 sites across 5 countries: United States, Hungary, Italy, Poland, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02710890. Inclusion in this directory is not an endorsement.