Open-label Brivaracetam adjunctive treatment in paediatric epilepsy
Research type
Research Study
Full title
OPEN-LABEL, SINGLE-ARM, MULTICENTER STUDY TO EVALUATE LONG-TERM SAFETY AND TOLERABILITY OF BRIVARACETAM USED AS ADJUNCTIVE TREATMENT IN PEDIATRIC STUDY PARTICIPANTS WITH EPILEPSY
IRAS ID
290595
Contact name
Marios Kaliakatsos
Contact email
Sponsor organisation
UCB Biopharma SRL
Eudract number
2020-003664-29
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND/IDE Number, 110606; IND/IDE Serial Number, 001
Duration of Study in the UK
3 years, 11 months, 30 days
Research summary
The purpose of this study is to evaluate the long-term safety and tolerability of brivaracetam (the study medication), as additional therapy for children with epilepsy.
This study will involve a total of approximately 100 male and female study participants aged 4 to 1 8 across the US, Mexico and Europe in centres which participate in the previous (core) studies with brivaracetam (N01266 and N01349), and in Japan where all study participants will be directly enrolled. Globally, participants may turn 18+ when rolling over from the feeder study N01266. This study allows for continued brivaracetam treatment for those with clinical benefit.
Depending on the core study participants are being rolled over from, participants can participate in this study and continue to receive the study medication for a maximum of 3 years (duration of 3 years combined from EP0156 and core study), or until approval of BRV has been obtained for paediatric study participants in their age range and indication, until another program according to local regulations is available, or until study participants transition into another Brivaracetam study.
The study medication will be provided as an oral solution. The study doctor will provide participants with an oral solution or oral tablets, as appropriate. To discontinue the study medication, a dose reduction schedule will be followed. Participants will have to visit the study doctor every 3 months. At each visit participants will receive a diary and the study doctor will instruct the participants parents/ guardians on how to complete it. Blood samples will also be taken for standard safety tests and additional blood samples of maximum 2 ml (less than a half teaspoon) may be required, if for safety evaluations a test needs to be performed to measure the amount of brivaracetam in the body.REC name
East of Scotland Research Ethics Service REC 2
REC reference
21/ES/0004
Date of REC Opinion
5 Feb 2021
REC opinion
Further Information Favourable Opinion