A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures
Condition(s) studied
Investigational drug(s) / intervention(s)
Brivaracetam: Brivaracetam (BRV) tablets or oral solution will be administered twice daily (bid) in 2 equally divided doses. Tablet strengths: 10 mg, 25 mg, 50 mg Route of administration: oral Oral solution Concentration: 10 mg/ml Route of administration: oral
Study summary
The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.
Eligibility
Primary outcome measure(s)
- Incidence of treatment-emergent adverse events (TEAEs) during the study — From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. - Incidence of treatment-emergent serious adverse events (SAEs) during the study — From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent disability/incapacity * Is a congenital anomaly or birth defect * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above - Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of study drug during the study — From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
Trial sites (36)
| Facility | City | Region | Status |
|---|---|---|---|
| Ep0156 259 | Hawthorne | New York | Completed |
| Ep0156 237 | Durham | North Carolina | Completed |
| Ep0156 204 | Leuven | Belgium | Withdrawn |
| Ep0156 240 | Prague | Czechia | Withdrawn |
| Ep0156 207 | Loos | France | Withdrawn |
| Ep0156 209 | Freiburg im Breisgau | Germany | Withdrawn |
| Ep0156 210 | Budapest | Hungary | Completed |
| Ep0156 247 | Budapest | Hungary | Completed |
| Ep0156 232 | Miskolc | Hungary | Completed |
| Ep0156 230 | Roma | Italy | Completed |
| Ep0156 803 | Bunkyō City | Japan | Active Not Recruiting |
| Ep0156 808 | Chūō | Japan | Active Not Recruiting |
| Ep0156 800 | Gifu | Japan | Active Not Recruiting |
| Ep0156 807 | Hiroshima | Japan | Active Not Recruiting |
| Ep0156 815 | Kodaira-shi | Japan | Recruiting |
| Ep0156 813 | Kōshi | Japan | Active Not Recruiting |
| Ep0156 806 | Kyoto | Japan | Active Not Recruiting |
| Ep0156 811 | Nagoya | Japan | Active Not Recruiting |
| Ep0156 812 | Niigata | Japan | Active Not Recruiting |
| Ep0156 817 | Osaka | Japan | Recruiting |
| Ep0156 818 | Ōbu | Japan | Recruiting |
| Ep0156 819 | Ōmura | Japan | Recruiting |
| Ep0156 805 | Sapporo | Japan | Active Not Recruiting |
| Ep0156 816 | Sendai | Japan | Recruiting |
| Ep0156 809 | Shimotsuke | Japan | Active Not Recruiting |
| Ep0156 814 | Shizuoka | Japan | Recruiting |
| Ep0156 804 | Tokyo | Japan | Active Not Recruiting |
| Ep0156 810 | Yokohama | Japan | Active Not Recruiting |
| Ep0156 802 | Yonago | Japan | Completed |
| Ep0156 223 | Aguascalientes | Mexico | Completed |
| Ep0156 609 | Culiacán | Mexico | Completed |
| Ep0156 603 | Guadalajara | Mexico | Completed |
| Ep0156 406 | Kielce | Poland | Completed |
| Ep0156 402 | Krakow | Poland | Completed |
| Ep0156 401 | Poznan | Poland | Completed |
| Ep0156 248 | Seville | Spain | Completed |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04715646 on ClinicalTrials.gov ↗ ← All trials in Italy