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

StatusRecruiting
PhasePhase 3
Started2021-03-11
View on ClinicalTrials.gov ↗

Amendment history

2026-07-24
Study Status v38
Re-verified, no change to tracked fields
2025-06-26
Study Status, Contacts/Locations v37
Study sites34→36
2025-06-04
Study Status v36
Primary completion date2029-07-17→2030-07-08
Completion date2029-07-17→2030-07-08
2025-06-03
Active, Not Recruiting→Recruiting Study Status, Study Design, Contacts/Locations v35
Trial statusActive, Not Recruiting→Recruiting
Study sites30→34
2025-05-15
Study Status, Contacts/Locations v34
Study sites29→30
Show 33 earlier versions
2025-05-01
Study Status, Contacts/Locations v33
Study sites27→29
2025-04-03
Study Status, Contacts/Locations v32
Study sites27 entries, revised
Ep0156 814817
2025-03-20
Study Status, Contacts/Locations v31
Study sites26→27
2024-12-23
2 amendments v29-v30
2 re-verifications since 2024-10-02, no change to tracked fields
2023-07-27
Study Status v28
Primary completion date2025-07-17→2029-07-17
Completion date2025-07-17→2029-07-17
2023-05-18
Study Status v27
Re-verified, no change to tracked fields
2022-07-07
Study Status, Contacts/Locations v26
Study sitesdetails revised at 1 of 26 sites
2022-05-31
Study Status, Contacts/Locations v25
Study sitesdetails revised at 1 of 26 sites
2022-05-05
Study Status, Contacts/Locations v24
Study sites27→26
2022-04-25
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v23
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-07-02→2025-07-17
Completion date2025-07-02→2025-07-17
Enrollment targetestimated 79→confirmed 70
Study sites31→27
2022-03-24
Study Status, Contacts/Locations v22
Study sites30→31
2022-03-14
Study Status v21
Primary completion date2025-05-02→2025-07-02
Completion date2025-05-02→2025-07-02
2022-01-25
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v20
Primary completion date2025-05→2025-05-02
Completion date2025-05→2025-05-02
Enrollment target100→79
Eligibility criteria-1,461 characters
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] and for whom a reasonable benefit from long-term administration of brivaracetam (BRV) is expected Inclusion criteria for directly enrolled (DE) study participants in Japan only Study participant is ≥ 4 years to < 16 years of age Stu [...] l-onset seizure (POS) after an adequate course of treatment (in the opinion of the Investigator) with at least 1 antiep [...] [...]
Study description-172 characters
EP0156 is designed to assess the long-term safety and tolerability of brivaracetamBRV (BRV) fromin pediatric study participants with epilepsy who participated in the neonatal study in neonates, N01349 [NCT03325439NCG03325439], and/or have participated in the ongoing, open-label, long-term, follow-up study in pediatric study participants, N01266 [NCT01364597], who have the opportunity to continue BRV treatment by participating in EP0156. EP0156 iswill also designed to assess the long-term safety and tolerability of BRV from directly enrolled (DE)in Japanese pediatric study participants with par [...] [...]
Study sitesdetails revised at 4 of 30 sites
Study title-4 characters
A Study to Test the Safety and Tolerability of Brivaracetam in PediatricChildren Studyand ParticipantsAdolescents With Seizures
2022-01-13
Study Status, Contacts/Locations v19
Study sitesdetails revised at 1 of 30 sites
2022-01-03
Study Status, Contacts/Locations v18
Study sites29→30
2021-12-09
Study Status, Contacts/Locations v17
Primary completion date2025-04→2025-05
Completion date2025-04→2025-05
Study sitesdetails revised at 4 of 29 sites
2021-11-09
Study Status, Contacts/Locations v16
Study sitesdetails revised at 12 of 29 sites
2021-11-08
Study Status, Contacts/Locations v15
Study sites27→29
2021-10-21
Study Status, Contacts/Locations v14
Study sites26→27
2021-10-07
Study Status, Contacts/Locations v13
Study sites24→26
2021-09-23
Study Status, Contacts/Locations v12
Study sites23→24
2021-08-26
Study Status, Contacts/Locations v11
Study sites22→23
2021-07-29
Study Status, Contacts/Locations v10
Study sites21→22
2021-07-15
Study Status, Contacts/Locations v9
Study sites20→21
2021-07-01
Study Status, Contacts/Locations v8
Study sites17→20
2021-06-03
Study Status, Contacts/Locations v7
Study sites15→17
2021-05-20
Study Status, Contacts/Locations v6
Study sites12→15
2021-05-06
Study Status, Contacts/Locations v5
Study sites9→12
2021-04-22
Study Status, Contacts/Locations v4
Study sites7→9
2021-04-08
Study Status, Contacts/Locations v3
Study sites4→7
2021-03-25
Study Status, Contacts/Locations v2
Study sites1→4
2021-03-16
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-01→confirmed 2021-03-11
Study sites0→1
2021-01-19
Original filing
UCB Biopharma SRL
68 trials monitored
See 4 trials at risk
Epilepsy
723 trials monitored
See 41 trials at risk
The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.
Trial Details
NCT Number NCT04715646
Lead Sponsor UCB Biopharma SRL
Conditions Epilepsy
Enrollment 70 participants
Start Date 2021-03-11
Primary Completion 2030-07-08 (estimated)
Study Completion 2030-07-08 (estimated)
Updated on ClinicalTrials.gov 2026-07-27