NCT04715646 A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures
| NCT ID | NCT04715646 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | UCB Biopharma SRL |
| Condition | Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2021-03-11 |
| Primary Completion | 2030-07-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 70 participants in total. It began in 2021-03-11 with a primary completion date of 2030-07-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.
Eligibility Criteria
Inclusion Criteria: Inclusion criteria for long-term follow-up (LTFU) study participants only * Study participants ≥ 1 month of age with a confirmed diagnosis of epilepsy who participated in core study N01266 \[NCT01364597\] and/or N01349 \[NCT03325439\] Inclusion criteria for directly enrolled (DE) study participants in Japan only * Study participant is ≥ 4 years to \< 16 years of age * Study participant has presence of an electroencephalogram (EEG) reading compatible with the diagnosis of focal epilepsy within the last 10 years * Study participant has uncontrolled partial-onset seizure (POS) after an adequate course of treatment with at least 1 antiepileptic drug (AED) * Study participant had at least 1 POS during the 4-week Screening Period Exclusion Criteria: Exclusion criteria for all study participants * Severe medical, neurological, or psychiatric disorders or laboratory values, which may have an impact on the safety of the study participant * Study participant is currently participating in another study of an investigational medication (or a medical device) other than brivaracetam (BRV). Exclusion criteria for long-term follow-up (LTFU) study participants only \- Study participant ≥ 6 years of age has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months as indicated on the Columbia Suicide Severity Rating Scale (C-SSRS) Exclusion criteria for directly enrolled (DE) study participants in Japan only * Study participant has a history of primary generalized epilepsy, psychogenic non-epileptic seizures, or febrile seizures * Study participant has a history of status epilepticus in the 30 days prior to the Screening Visit (ScrV) or during the Screening Period * Study participant has any clinically significant illness * 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 * Study participant has a clinically significant ECG abnormality * Study participant had major surgery within 6 months prior to the ScrV
Contact & Investigator
UCB Cares
STUDY DIRECTOR
001 844 599 2273 (UCB)
Frequently Asked Questions
Who can join the NCT04715646 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, studying Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04715646 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 70 participants.
Is NCT04715646 currently recruiting?
Yes, NCT04715646 is actively recruiting participants. Contact the research team at UCBCares@ucb.com for enrollment information.
Where is the NCT04715646 trial being conducted?
This trial is being conducted at Hawthorne, United States, Durham, United States, Leuven, Belgium, Prague, Czechia and 11 additional locations.
Who is sponsoring the NCT04715646 clinical trial?
NCT04715646 is sponsored by UCB Biopharma SRL. The principal investigator is UCB Cares at 001 844 599 2273 (UCB). The trial plans to enroll 70 participants.
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