Long term study of BRV

• Research type

  Research Study

• Full title

  OPEN-LABEL, SINGLE-ARM, MULTICENTER, LONG-TERM STUDY TO EVALUATE SAFETY AND EFFICACY OF BRIVARACETAM USED AS ADJUNCTIVE TREATMENT IN PEDIATRIC SUBJECTS WITH EPILEPSY

• IRAS ID

  224333

• Contact name

  Ronit Pressler

• Contact email

  Ronit.Pressler@gosh.nhs.uk

• Sponsor organisation

  UCB Pharma SA

• Eudract number

  2011-000374-60

• Clinicaltrials.gov Identifier

  NCT01364597

• Clinicaltrials.gov Identifier

  110606, IND Number:

• Duration of Study in the UK

  5 years, 2 months, 25 days

• Research summary

  Summary of Research
  This is a long term extension study investigating the treatment of epilepsy with brivaracetam (the study medication).
  Epilepsy, a recurrence of seizures, is a neurological disorder that affects about 4-6 out of 1000 children aged under 20 years of age. Seizures, as part of an epilepsy syndrome or as an acute symptomatic event is the most common neurological emergency in the neonatal period occurring in about 2-3 / 100 life births. Treatment for epilepsy in childhood generally follows that of adults with anti-epileptic drugs (AEDs). Despite the availability of new AEDs, more than 25% of paediatric patients have inadequate seizure control on currently available AEDs or experience significant side effects. This situation is even worse for acute symptomatic seizures in the neonatal period where only 60% respond to currently available anti-seizure medication.

  The purpose of this study is to see if brivaracetam is safe in the long term, treating children with epilepsy and give participants from other (core) UCB epilepsy studies the chance to continue on brivaracetam.
  In this study, approximately 600 male and female patients will be enrolled, aged 1 month and above up to 17 years of age, at around 100 centres worldwide.
  Participants who took part in a core study will continue on the same dose as they finished the previous study, directly enrolled participants will have their dose determined during the first dosing period of the study.

  The participants will visit the clinic monthly for the first three months (weekly if directly enrolled) and then every three months for at least 3 years until the study medication becomes available on the market. They will undergo various study procedures to assess the safety and efficacy of brivaracetam.

  Summary of Results
  Not yet available. Will be posted on https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.ucb.com%2F&data=05%7C01%7Capprovals%40hra.nhs.uk%7C8b1ddd3e82b044448d5f08da60c76165%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637928706687622760%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=l5T%2Bg8ZSnYy78oCm4PIHly4RZNqwZ8gMth5naa6y7HI%3D&reserved=0

• REC name

  London - Brent Research Ethics Committee

• REC reference

  17/LO/0728

• Date of REC Opinion

  2 Aug 2017

• REC opinion

  Further Information Favourable Opinion