RECRUITING

A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures

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Conditions

EpilepsyBrivaracetamPediatricChild

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.

Official Title

Open-Label, Single-Arm, Multicenter Study to Evaluate Long-Term Safety and Tolerability of Brivaracetam Used as Adjunctive Treatment in Pediatric Study Participants With Epilepsy

Quick Facts

Study Start:2021-03-11
Study Completion:2029-07-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04715646

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Month
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Study participants ≥ 1 month of age with a confirmed diagnosis of epilepsy who participated in core study N01266 \[NCT01364597\] and/or N01349 \[NCT03325439\]
  2. * Study participant is ≥ 4 years to \< 16 years of age
  3. * Study participant has presence of an electroencephalogram (EEG) reading compatible with the diagnosis of focal epilepsy within the last 10 years
  4. * Study participant has uncontrolled partial-onset seizure (POS) after an adequate course of treatment with at least 1 antiepileptic drug (AED)
  5. * Study participant had at least 1 POS during the 4-week Screening Period
  1. * Severe medical, neurological, or psychiatric disorders or laboratory values, which may have an impact on the safety of the study participant
  2. * Study participant is currently participating in another study of an investigational medication (or a medical device) other than brivaracetam (BRV).
  3. * Study participant has a history of primary generalized epilepsy, psychogenic non-epileptic seizures, or febrile seizures
  4. * Study participant has a history of status epilepticus in the 30 days prior to the Screening Visit (ScrV) or during the Screening Period
  5. * Study participant has any clinically significant illness
  6. * Study participant has clinically significant laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results
  7. * Study participant has a clinically significant ECG abnormality
  8. * Study participant had major surgery within 6 months prior to the ScrV

Contacts and Locations

Study Contact

UCB Cares
CONTACT
0018445992273
UCBCares@ucb.com

Principal Investigator

UCB Cares
STUDY_DIRECTOR
001 844 599 2273 (UCB)

Study Locations (Sites)

Ep0156 259
Hawthorne, New York, 10532
United States
Ep0156 237
Durham, North Carolina, 27710
United States

Collaborators and Investigators

Sponsor: UCB Biopharma SRL

  • UCB Cares, STUDY_DIRECTOR, 001 844 599 2273 (UCB)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-11
Study Completion Date2029-07-17

Study Record Updates

Study Start Date2021-03-11
Study Completion Date2029-07-17

Terms related to this study

Keywords Provided by Researchers

  • Epilepsy
  • Brivaracetam
  • Pediatric
  • Child

Additional Relevant MeSH Terms

  • Epilepsy