Open-label, Pharmacokinetic, Safety and Efficacy Study of Adjunctive Brivaracetam in Children With Epilepsy.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00422422
• Date of registration: 10/01/2007
• Prospective Registration: Yes
• Primary sponsor: UCB Pharma
• Public title: Open-label, Pharmacokinetic, Safety and Efficacy Study of Adjunctive Brivaracetam in Children With Epilepsy.
• Scientific title: Open-Label, Single-Arm, Multicenter, Pharmacokinetic, Safety, and Efficacy Study of Adjunctive Administration of Brivaracetam in Subjects From =1 Month to <16 Years Old With Epilepsy
• Date of first enrolment: July 2011
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00422422
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Belgium, Czech Republic, Czechia, Mexico, Poland, Spain, United States

Contacts

• Name: UCB Clinical Trial Call Center
• Affiliation: [phone] (UCB)

Key inclusion & exclusion criteria

Inclusion Criteria:

- Clinical diagnosis of epilepsy

- Subject having at least 1 seizure (any type) during the 3 weeks before first visit

- Stable dosing of 1-3 concomitant antiepileptic drugs

Exclusion Criteria:

- Pregnant or nursing females

- Concomitant use of Levetiracetam

- Epilepsy secondary to a Progressive cerebral disease/tumor or other neurodegenerative
disease

- History of status epilepticus

- Clinically significant acute or chronic illness, underlying disease or medication
condition

- History of suicide attempt



Age minimum: 1 Month
Age maximum: 16 Years
Gender: All

Health Condition(s) or Problem(s) studied

Epilepsy

Intervention(s)

Drug: Brivaracetam

Primary Outcome(s)

Mean Max Plasma Concentration for Age Range =12 to <16 Years [Time Frame: Day 21]

Mean Trough Plasma Concentration at 3rd Level for Age Range =1 Month to <2 Years [Time Frame: Day 21]

Mean Max Plasma Concentration for Age Range =1 Month to <2 Years [Time Frame: Day 21]

Mean Trough Plasma Concentration at 3rd Level for Age Range =2 to <12 Years [Time Frame: Day 21]

Mean Trough Plasma Concentration at 3rd Level for Age Range =12 to <16 Years [Time Frame: Day 21]

Mean Max Plasma Concentration for Age Range =2 to <12 Years [Time Frame: Day 21]

Secondary Outcome(s)

Number of Subjects With a 50 % Reduction in Seizures Based on Seizure Diary Data From Baseline to End of the 3-week Evaluation Period [Time Frame: Baseline to end of the 3-week evaluation period]

Number of Subjects With at Least One Treatment-emergent Adverse Event Reported During the 3-week Evaluation Period [Time Frame: Baseline to end of the 3-week evaluation period]

Percent Compliance With Brivaracetam Oral Solution During the 3-week Evaluation Period [Time Frame: Baseline to the end of the 3-week evaluation period]

Secondary ID(s)

2006-006536-22

N01263

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/01/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00422422