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Antiepileptic
Brivaracetam for Epilepsy
Phase 3
Waitlist Available
Research Sponsored by UCB Biopharma SRL
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Study participants ≥ 1 month of age with a confirmed diagnosis of epilepsy who participated in core study N01266 [NCT01364597] and/or N01349 [NCT03325439]
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from evaluation visit (day 1) until safety visits (up to 5 years)
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial will help researchers learn more about the long-term effects of brivaracetam and how safe it is for people to take.
Who is the study for?
This trial is for children and adolescents with epilepsy. Eligible participants are those aged ≥4 to <16 years in Japan, or those who have been part of previous studies N01266 or N01349 at any age over 1 month. They must have a diagnosis of focal epilepsy and uncontrolled partial-onset seizures despite treatment with at least one antiepileptic drug.
What is being tested?
The study is testing the long-term safety and tolerability of a medication called Brivaracetam, which is used to treat seizures in individuals diagnosed with epilepsy.
What are the potential side effects?
While not explicitly listed here, common side effects associated with Brivaracetam may include drowsiness, dizziness, fatigue, nausea and behavioral changes such as irritability or aggression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have epilepsy and was part of the N01266 or N01349 study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from evaluation visit (day 1) until safety visits (up to 5 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from evaluation visit (day 1) until safety visits (up to 5 years)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of treatment-emergent adverse events (TEAEs) during the study
Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of study drug during the study
Incidence of treatment-emergent serious adverse events (SAEs) during the study
Side effects data
From 2022 Phase 3 trial • 449 Patients • NCT0308366519%
Somnolence
14%
Dizziness
7%
Nasopharyngitis
5%
Upper respiratory tract infection
5%
Headache
1%
Miscarriage of partner
1%
Pyrexia
1%
Calculus ureteric
1%
Large intestine polyp
100%
80%
60%
40%
20%
0%
Study treatment Arm
BRV 200 mg/Day
Placebo
BRV 50 mg/Day
Placebo to OLTP BRV
BRV 50 mg/Day to OLTP BRV
BRV 200 mg/Day to OLTP BRV
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: BrivaracetamExperimental Treatment1 Intervention
LTFU study participants: Up to 5mg/kg/day (for study participants weighing 11kg to less than 20kg) and up to 4mg/kg/day (for study participants weighing 20kg to less than 50kg) and no more than 200mg/day Directly enrolled (DE) study participants: 1mg/kg/day to 4mg/kg/day and no more than 200mg/day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brivaracetam
2019
Completed Phase 3
~4500
Find a Location
Who is running the clinical trial?
UCB Biopharma SRLLead Sponsor
113 Previous Clinical Trials
23,079 Total Patients Enrolled
14 Trials studying Epilepsy
2,400 Patients Enrolled for Epilepsy
UCB CaresStudy Director001 844 599 2273 (UCB)
217 Previous Clinical Trials
46,443 Total Patients Enrolled
50 Trials studying Epilepsy
11,795 Patients Enrolled for Epilepsy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have epilepsy and was part of the N01266 or N01349 study.You have had a severe seizure within the last 30 days before the screening visit.I had major surgery within the last 6 months (Japan only).You have had an EEG test showing signs of focal epilepsy in the past 10 years (only for people who joined the study directly in Japan).I am over 6 and have had thoughts of or attempted suicide, as per the C-SSRS.The study participant has a significant abnormality in their heart's electrical activity as shown in an ECG test (only for participants enrolled in Japan directly).If you are participating in the study in Japan, you had a positive pregnancy test during the 4-week Screening Period.I do not have severe health or mental conditions that could affect my safety in the study.I am between 4 and 16 years old and live in Japan.You have a history of certain types of seizures.I still have seizures despite taking epilepsy medication.
Research Study Groups:
This trial has the following groups:- Group 1: Brivaracetam
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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