A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy
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|ClinicalTrials.gov Identifier: NCT03405714|
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : March 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: Brivaracetam||Phase 2|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month < 16 Years of Age With Epilepsy|
|Actual Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
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.
Other Name: Briviact
- Incidence of adverse events throughout the study [ Time Frame: From Screening (Day -20 to -1) until last visit (up to day 68) ]An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
- Number of subject withdrawals due to AEs [ Time Frame: From Screening (Day -20 to -1) until last visit (up to day 68) ]An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
- Plasma concentration of brivaracetam (BRV) [ Time Frame: Blood samples will be collected <= 1 hour pre-initiation of intravenous (iv) BRV infusion and 15 min and 3 hours post-initiation of iv BRV infusion. ]Blood samples will be taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03405714
|Contact: UCB Cares||+1844599 ext 2273||UCBCares@ucb.com|
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|Study Director:||UCB Cares||001 844 599 2273 (UCB)|