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Antiepileptic Drug
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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from full evaluation visit (month 6) up to the final visit (month 24)
Awards & highlights
Study Summary
This trial will study the safety and effectiveness of a drug called brivaracetam in children with absence seizures.
Who is the study for?
This trial is for children and young adults aged 2 to 26 with Childhood Absence Epilepsy or Juvenile Absence Epilepsy. Participants must not be pregnant, breastfeeding, and if sexually active, agree to use contraception. They should have no severe medical issues or history of non-epileptic seizures and not be at risk of suicide.Check my eligibility
What is being tested?
The study tests the long-term safety and effectiveness of Brivaracetam, either as a tablet or oral solution, in treating absence seizures in pediatric patients with specific types of epilepsy.See study design
What are the potential side effects?
Possible side effects include sleepiness, dizziness, fatigue, behavioral changes like aggression or agitation, gastrointestinal symptoms such as nausea or vomiting, potential allergic reactions to medication components.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from full evaluation visit (month 6) up to the final visit (month 24)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from full evaluation visit (month 6) up to the final visit (month 24)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of participants with treatment-emergent adverse events (TEAEs)
Percentage of participants with treatment-emergent adverse events (TEAEs) leading to discontinuation of study treatment
Secondary outcome measures
Percentage of participants with absence seizure freedom based on diary over the entire evaluation period and by 3-month time intervals
Percentage of participants with absence seizure freedom within 4 days prior to or during the 1-hour electroencephalogram (EEG) at each applicable visit
Percentage of participants with serious adverse events (SAEs) during the study
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Brivaracetam armExperimental Treatment2 Interventions
Subjects in this arm will receive various brivaracetam doses as oral solution or film-coated tablet twice per day.
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Who is running the clinical trial?
UCB Biopharma SRLLead Sponsor
101 Previous Clinical Trials
21,296 Total Patients Enrolled
2 Trials studying Childhood Absence Epilepsy
280 Patients Enrolled for Childhood Absence Epilepsy
UCB CaresStudy Director001 844 599 2273 (UCB)
205 Previous Clinical Trials
44,823 Total Patients Enrolled
1 Trials studying Childhood Absence Epilepsy
160 Patients Enrolled for Childhood Absence Epilepsy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use birth control and not donate sperm during and for 2 days after treatment.I was in the N01269 study, have CAE or JAE, and could benefit from long-term BRV.My liver isn't working properly according to my doctor's assessment.I have had seizures that are not caused by epilepsy.I am on dialysis for end-stage kidney disease.I am allergic to brivaracetam or its ingredients, or I have fructose intolerance.I am currently taking specific seizure medications.I am not pregnant or breastfeeding, and if I can have children, I agree to use contraception as advised.
Research Study Groups:
This trial has the following groups:- Group 1: Brivaracetam arm
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the precedent for Brivaracetam oral solution in medical research?
"Brivaracetam oral solution was first studied in 2017 under the identifier Ep0085 926. As of now, there are a total of 27 completed trials and 6 ongoing studies. A notable number of these live studies are based in Denver, Colorado."
Answered by AI
Have patients undergone this trial previously?
"There are 6 ongoing clinical trials for Brivaracetam oral solution in 18 cities across 16 nations. The first trial was held in 2017 and, to date, 27 have been completed. That particular study- undertaken by UCB Biopharma S.P.R.L.- had 227 participants and reached Phase 3 approval."
Answered by AI
Are there any negative effects to taking Brivaracetam orally?
"There is already some data to support the efficacy of Brivaracetam oral solution, and it has received positive safety reports in multiple rounds of testing. Consequently, we have given it a score of 3."
Answered by AI
Does this research project allow for seniors to participate?
"This trial is only for children and young adults aged 2-26. Out of the 111 similar trials, this one specifically focuses on patients who are under 18 years old. 159 other trials focus on those over 65."
Answered by AI
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