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Antiepileptic

Brivaracetam for Epilepsy

Q: Are there any precedents for Brivaracetam's clinical usage?

Brivaracetam is being studied in 6 different clinical trials, 4 of which are Phase 3 studies. Most of the research facilities for Brivaracetam are located in Tbilisi and <a href="https://www.withpower.com/clinical-trials/pennsylvania">Pennsylvania</a>; however, there are a total of 197 sites running these trials.

Q: Has this research been done before?

Brivaracetam has been under investigation since early 2017. The first clinical trial, sponsored by UCB Biopharma S.P.R.L., took place in the same year and included 227 patients. After the Phase 3 drug approval was given in response to the initial study, 6 more trials involving Brivaracetam have appeared across 16 countries and 18 cities.

Q: Are patients being recruited for this experiment as we speak?

The clinicaltrials.gov site indicates that this study is not looking for participants at the moment. This trial was originally posted on March 11th, 2021 and was last updated on July 7th, 2022. There are 248 other trials that are recruiting patients right now.

Q: What is the level of risk involved in taking Brivaracetam?

Brivaracetam's safety is estimated to be a 3. This is Phase 3, which suggests that not only is there data supporting efficacy, but also multiple rounds of data affirming its safety.

Q: How many people are being given the chance to participate in this research project?

Right now, this clinical study is not looking for any participants. The trial was originally posted on March 11th, 2021 and was updated on July 7th, 2022. However, there are other trials you may be eligible for; 242 studies involving aura and 6 different trials testing Brivaracetam are currently admitting patients.

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

Study 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.Check my eligibility

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.See study design

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 below

Select...

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from evaluation visit (day 1) until safety visits (up to 5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 • NCT03083665

Nasopharyngitis

Dizziness

Hyponatraemia

Cervicogenic headache

100%

80%

60%

40%

20%

Study treatment Arm

BRV 200 mg/Day to OLTP BRV

Placebo

BRV 50 mg/Day

BRV 200 mg/Day

BRV 50 mg/Day to OLTP BRV

Placebo to OLTP BRV

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

~4510

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor

101 Previous Clinical Trials

21,366 Total Patients Enrolled

14 Trials studying Epilepsy

2,400 Patients Enrolled for Epilepsy

UCB CaresStudy Director001 844 599 2273 (UCB)

205 Previous Clinical Trials

44,893 Total Patients Enrolled

49 Trials studying Epilepsy

11,784 Patients Enrolled for Epilepsy

Media Library

Brivaracetam (Antiepileptic) Clinical Trial Eligibility Overview. Trial Name: NCT04715646 — Phase 3

Epilepsy Research Study Groups: Brivaracetam

Epilepsy Clinical Trial 2023: Brivaracetam Highlights & Side Effects. Trial Name: NCT04715646 — Phase 3

Brivaracetam (Antiepileptic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04715646 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any precedents for Brivaracetam's clinical usage?

"Brivaracetam is being studied in 6 different clinical trials, 4 of which are Phase 3 studies. Most of the research facilities for Brivaracetam are located in Tbilisi and Pennsylvania; however, there are a total of 197 sites running these trials."

Answered by AI

Has this research been done before?

"Brivaracetam has been under investigation since early 2017. The first clinical trial, sponsored by UCB Biopharma S.P.R.L., took place in the same year and included 227 patients. After the Phase 3 drug approval was given in response to the initial study, 6 more trials involving Brivaracetam have appeared across 16 countries and 18 cities."

Answered by AI

Are patients being recruited for this experiment as we speak?

"The clinicaltrials.gov site indicates that this study is not looking for participants at the moment. This trial was originally posted on March 11th, 2021 and was last updated on July 7th, 2022. There are 248 other trials that are recruiting patients right now."

Answered by AI

What is the level of risk involved in taking Brivaracetam?

"Brivaracetam's safety is estimated to be a 3. This is Phase 3, which suggests that not only is there data supporting efficacy, but also multiple rounds of data affirming its safety."

Answered by AI

How many people are being given the chance to participate in this research project?

"Right now, this clinical study is not looking for any participants. The trial was originally posted on March 11th, 2021 and was updated on July 7th, 2022. However, there are other trials you may be eligible for; 242 studies involving aura and 6 different trials testing Brivaracetam are currently admitting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04715646.

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