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A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy

NCT03405714 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-05-11

Study results available
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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

DRUG

Brivaracetam

* Pharmaceutical form: Solution for iv injection * Route of administration: intravenous use * Concentration: 10 mg/ml

Sponsors & Collaborators

  • UCB Biopharma S.P.R.L.

    lead INDUSTRY

Principal Investigators

  • UCB Cares · 001 844 599 2273 (UCB)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2020-11-04
Completion
2020-11-04
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Germany
  • Hungary
  • Italy
  • Mexico
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03405714 on ClinicalTrials.gov