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

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04715646
• Other study ID #: EP0156
• Secondary ID: 2020-003664-29
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 11, 2021
• Est. completion date: July 17, 2029

Study information

• Verified date: July 2023
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

EP0156 is designed to assess the long-term safety and tolerability of BRV in pediatric study participants with epilepsy who participated in the neonatal study N01349 [NCG03325439] and/or have participated in the open-label, long-term, follow-up pediatric study N01266 [NCT01364597]. EP0156 will also assess the long-term safety and tolerability of BRV in Japanese pediatric study participants with partial-onset seizures who will be directly enrolled into the study in Japan. Pharmacokinetic data will also be evaluated in Japanese study participants.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: July 17, 2029
• Est. primary completion date: July 17, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Hungary	Ep0156 210	Budapest
Hungary	Ep0156 247	Budapest
Hungary	Ep0156 232	Miskolc
Italy	Ep0156 230	Roma
Japan	Ep0156 803	Bunkyo-ku
Japan	Ep0156 808	Chuo
Japan	Ep0156 800	Gifu-City
Japan	Ep0156 807	Hiroshima
Japan	Ep0156 813	Koshi
Japan	Ep0156 806	Kyoto
Japan	Ep0156 811	Nagoya
Japan	Ep0156 812	Niigata-city
Japan	Ep0156 805	Sapporo-city
Japan	Ep0156 809	Shimotsuke
Japan	Ep0156 804	Tokyo
Japan	Ep0156 810	Yokohama
Japan	Ep0156 802	Yonago
Mexico	Ep0156 223	Aguascalientes
Mexico	Ep0156 609	Culiacan
Mexico	Ep0156 603	Guadalajara
Poland	Ep0156 406	Kielce
Poland	Ep0156 402	Krakow
Poland	Ep0156 401	Poznan
Spain	Ep0156 248	Sevilla
United States	Ep0156 237	Durham	North Carolina
United States	Ep0156 259	Hawthorne	New York

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

United States,  Hungary,  Italy,  Japan,  Mexico,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (TEAEs) during the study	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.	From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)
Primary	Incidence of treatment-emergent serious adverse events (SAEs) during the study	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	From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)
Primary	Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of study drug during the study	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.	From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)