Long term Safety TOPAMAX monotherapy in paediatric patients
Research type
Research Study
Full title
A Randomized, Active-Controlled, Open-Label, Flexible-Dose Study to Assess the Safety and Tolerability of Topiramate as Monotherapy Compared With Levetiracetam as Monotherapy in Pediatric Subjects With New or Recent-Onset Epilepsy
IRAS ID
177143
Contact name
Jessica Bainbridge
Contact email
Sponsor organisation
Janssen-Cilag International N.V.
Eudract number
2012-001552-19
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 9 months, 21 days
Research summary
Epilepsy is a common serious neurological condition where there is a tendency to have seizures that start in the brain. Epilepsy is most often diagnosed after a person has had more than one seizure. Epilepsy can start at any age, but it most often begins during childhood. It's often not possible to identify a specific reason why someone develops the condition, although some cases, particularly those that occur later in life are associated with damage to the brain.
For most people with epilepsy, treatment with medications called anti-epileptic drugs (AEDs) is recommended. These medications cannot cure epilepsy, but they are often very effective in controlling seizures. It can take some time to find the right type and correct dose of AED before seizures can be controlled.
In a few cases, surgery may be used to remove a specific area of the brain that is affected or to install an electrical device that can help control seizures.Janssen Research & Development, LLC is sponsoring this safety study to assess the Safety and Tolerability of Topiramate as Monotherapy Compared With Levetiracetam.
Participants will be assigned randomly (by chance, like the flip of a coin) to receive either topiramate or levetiracetam.There are 2 dosing groups in this study. The dose the participant will receive will be based on their weight. If the participant is less than 10 years old and is assigned to take topiramate, the highest dose of topiramate they will receive is 350mg/day. If the participant is 10 to 15 years old, the highest dose they may receive is 400mg per day.
If the participant is assigned to take levetiracetam, the highest dose of levetiracetam they will receive is 60mg/kg per day.
About 282 participants, ages 2 to 15 years old, will take part in the study. The study will be conducted at about 90 sites in up to 22 different countries.
REC name
London - City & East Research Ethics Committee
REC reference
16/LO/0392
Date of REC Opinion
16 Mar 2016
REC opinion
Unfavourable Opinion