A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy
NCT ID: NCT03405714
Last Updated: 2022-05-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2018-06-01
2020-11-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam
NCT00761774
Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Suffering From Epilepsy
NCT00175916
Evaluation of Long-term Safety, and Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects With Epilepsy
NCT01728077
Safety and Tolerability of Intravenous Brivaracetam (Infusion or Bolus) as Adjunctive Antiepileptic Therapy
NCT01405508
A Study to Test the Safety/ Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization
NCT03250377
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Brivaracetam
Brivaracetam will be administered to various age-based cohorts. Cohort 1: Subjects \>=12 to \<16 years; Cohort 2: Subjects \>=6 to \<12 years; Cohort 3: Subjects \>=2 to \<6 years; Cohort 4: Subjects 1 month to \<2 years. Enrollment will be sequential by descending age beginning with Cohort 1. For each cohort, the first half will receive a 15-minute iv infusion. The Data Monitoring Committee (DMC) will then review safety and, as available, PK data to make the following recommendations: the progression of the current cohort (up to 2-minute iv bolus infusion) and progression to initiate enrollment in the preceding cohort.
Brivaracetam
* Pharmaceutical form: Solution for iv injection
* Route of administration: intravenous use
* Concentration: 10 mg/ml
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Brivaracetam
* Pharmaceutical form: Solution for iv injection
* Route of administration: intravenous use
* Concentration: 10 mg/ml
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Weight \>= 3 kg (6.6 lbs)
* Diagnosis of epilepsy
* Acceptable candidate for venipuncture and intravenous (iv) infusion
* Treatment with \>=1 anti epileptic drug (AED; including BRV) without a change of dose regimen for at least 7 days prior to Screening
* No treatment with vagus nerve stimulation (VNS), OR the subject is being treated with VNS and the settings have been constant for \>=7 days prior to Screening
* For female subjects: not of childbearing potential, OR of childbearing potential and not sexually active/negative pregnancy test, OR of childbearing potential and sexually active/negative pregnancy test/uses medically acceptable contraceptive methods
Exclusion Criteria
* Subject is being treated with BRV at a dose \>5mg/kg/day (rounded) or \>200mg/day for subjects with body weights \>40kg
* Subject requires or is likely to require a change in concomitant antiepileptic drug(s) (AED\[s\]), dose of concomitant AED(s), or formulation of AED(s) during the 7 days prior to the intravenous (iv) pharmacokinetic (PK) Period
* Subject is likely, in the opinion of the Investigator, to require rescue medication during the Initiating Oral BRV (IOB) Treatment or iv PK Periods
* Subject has experienced generalized convulsive status epilepticus in the 28 days prior to Screening or during the Screening Period
1 Month
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
UCB Biopharma S.P.R.L.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273 (UCB)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ep0065 252
The Bronx, New York, United States
Ep0065 237
Durham, North Carolina, United States
Ep0065 502
Hradec Králové, , Czechia
Ep0065 240
Prague, , Czechia
Ep0065 242
Berlin, , Germany
Ep0065 254
Bielefeld, , Germany
Ep0065 210
Budapest, , Hungary
Ep0065 224
Budapest, , Hungary
Ep0065 247
Budapest, , Hungary
Ep0065 222
Debrecen, , Hungary
Ep0065 232
Miskolc, , Hungary
Ep0065 264
Milan, , Italy
Ep0065 238
Pavia, , Italy
Ep0065 239
Pavia, , Italy
Ep0065 230
Roma, , Italy
Ep0065 223
Aguas Calientes, , Mexico
Ep0065 248
Seville, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Farkas MK, Kang H, Fogarasi A, Bozorg A, James GD, Krauwinkel W, Morita D, Will E, Elshoff JP. Pharmacokinetics, safety, and tolerability of intravenous brivaracetam in pediatric patients with epilepsy: An open-label trial. Epilepsia. 2022 Apr;63(4):855-864. doi: 10.1111/epi.17187. Epub 2022 Feb 23.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Product Information
FDA Safety Alerts and Recalls
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016-002452-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EP0065
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.