Study Summary
This trial is testing a new drug for kids with absence seizures.
- Childhood Absence Epilepsy
- Juvenile Absence Epilepsy
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 9 Secondary · Reporting Duration: From Screening Period (Day -14 to Day -2) until End of Safety Follow-Up (up to Week 23)
Trial Safety
Phase-Based Safety
Side Effects for
Awards & Highlights
Trial Design
8 Treatment Groups
Optimal dose of BRV (defined following Stage 1)
1 of 8
Placebo to BRV optimal dose (defined following Stage 1)
1 of 8
Brivaracetam 200 mg
1 of 8
Placebo to 200 mg brivaracetam
1 of 8
Brivaracetam 100 mg
1 of 8
Placebo to 100 mg brivaracetam
1 of 8
Brivaracetam received during RDW
1 of 8
Placebo received during RDW
1 of 8
Experimental Treatment
160 Total Participants · 8 Treatment Groups
Primary Treatment: Brivaracetam · Has Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 2 - 25 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Bast, Thomas, Anne‐Liv Schulz, Florin Floricel, Diego Morita, Jody M. Cleveland, and Jan‐Peer Elshoff. 2022. “Efficacy and Tolerability of Brivaracetam Monotherapy in Childhood and Juvenile Absence Epilepsy: An Innovative Adaptive Trial Design”. Epilepsia Open. Wiley. doi:10.1002/epi4.12628.
- Bast T, Schulz AL, Floricel F, Morita D, Cleveland JM, Elshoff JP. Efficacy and tolerability of brivaracetam monotherapy in childhood and juvenile absence epilepsy: An innovative adaptive trial design. Epilepsia Open. 2022 Dec;7(4):588-597. doi: 10.1002/epi4.12628. Epub 2022 Aug 4.
- Bast T, Schulz AL, Floricel F, Morita D, Cleveland JM, Elshoff JP. Efficacy and tolerability of brivaracetam monotherapy in childhood and juvenile absence epilepsy: An innovative adaptive trial design. Epilepsia Open. 2022 Dec;7(4):588-597. doi: 10.1002/epi4.12628. Epub 2022 Aug 4.
- 2021. "A Study to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04666610.
Frequently Asked Questions
Could you please summarize the risks associated with Brivaracetam?
"Brivaracetam has received a safety score of 3. This is based on the fact that it is a Phase 3 trial, meaning there is some data supporting efficacy and multiple rounds of data supporting safety." - Anonymous Online Contributor
Will this clinical trial provide new information not yet gathered?
"Brivaracetam was first studied in 2017 by UCB Biopharma S.P.R.L.. The company's initial study involved 227 people and, after Phase 3 approval, 6 more live studies were launched in 16 different countries." - Anonymous Online Contributor
For which patients is this research project meant?
"This medical trial is looking for 160 participants that suffer from childhood absence epilepsy, are aged 2-25, and meet the following additional requirements: They must be untreated with antiepileptic drugs (AEDs) or pretreated for absence seizures with a maximum of 2 historical AEDs, but without AED treatment for a period of at least 5 half-lives of the AED before randomization into this study. The UCB study physician should be consulted if in doubt, Study participant is without treatment with psychoactive drugs or on a stable dose for at least 2 weeks prior to randomization, Body weight is" - Anonymous Online Contributor
What do we know about Brivaracetam from other research?
"Brivaracetam is being studied in six clinical trials, four of which are Phase 3. Although the majority of research for Brivaracetam takes place in Poznan and New York, there are a total of 197 locations conducting these medical studies." - Anonymous Online Contributor
Are there many places in the state where this clinical trial is taking place?
"Right now, there are 17 clinical trial sites looking for patients to enroll. If you choose to participate in this study, it is important to try and pick a location near you so that travelling isn't too much of an inconvenience. The locations recruiting patients right now are Orlando, Wellington, Denver and 14 other places." - Anonymous Online Contributor
If a patient is under 40, do they still qualify for the research program?
"This trial is only for children aged 2 to 25. Out of the other 270 trials, 111 are for patients under 18 and 159 are for senior citizens over 65 years old." - Anonymous Online Contributor
How many people are taking part in this research project?
"One hundred and sixty patients who meet the specific inclusion criteria are needed for this clinical trial. The locations of these medical centres include Orlando, Colorado and Wellington, California." - Anonymous Online Contributor
Are people still being accepted into this trial program?
"That is correct, the clinical trial mentioned is still recruiting patients. Based on the information found on clinicaltrials.gov, the trial was posted on 7/29/2021 and last edited on 11/10/2022. A total of 160 patients are being enrolled at 17 different locations." - Anonymous Online Contributor