Trial Summary and Frequently Asked Questions

What is the essential information I need to know about EcLiPSE?
Long lasting seizures are:
      a medical emergency and
      need to be treated as quickly as possible.
 


There are two possible medicines:

     Phenytoin
   
 Levetiracetam (Keppra) 

In order to know which medicine works best in an emergency (phenytoin or Keppra) we need to use them without delaying treatment.
 


If you (or your child) has a long lasting seizure we may treat you/your child with
one of these two medicines as part of the EcLiPSE study.  

Once the  medical emergency has passed and if you (or your child) have been included in the study, a member of the EcLiPSE team at your site will speak to you about EcLiPSE.
 

What do I need to know about phenytoin and levetiracetam?
        Phenytoin
Phenytoin is the medicine usually given. This medicine has been used to treat children and young people in this way for many years and your child may have received phenytoin as part of  their routine care.

Phenytoin will usually stop the seizure in just over half of the children and young people who receive it. This medicine has to be given slowly and carefully because it can cause serious side-effects that may affect the heart, blood pressure and skin.
 

       Levetiracetam (Keppra)
Keppra is another medicine that is commonly used to help prevent seizures in children and young people. It has been used occasionally in the emergency setting for children and young people with long lasting seizures.

Studies of Keppra in adult emergency situations suggest that it may be a useful alternative medicine to phenytoin. Keppra can be given more quickly than phenytoin.
No serious side effects have been reported with the use of Keppra, but it may cause mild sedation, agitation, or a skin reaction including swelling of the tongue and lips and/or a red itchy rash. 
 

How will it be decided what treatment is given? 
In this study children and young people have an equal chance of receiving either phenytoin or Keppra. The treatment order for the two medicines has already been decided by a computer programme.

What happens after treatment?
The doctors and nurses will continue to monitor you (or your child) closely and treat according to local practice. A member of the EcLiPSE will also come and speak to you about the study. You will be able to ask them questions you may have about the study. The team will then ask whether you would be happy for them to collect some information on you/your child. This information will then be used to help find out which treatment works best.

The results of this study could help to improve the way other children with long lasting seizures are treated in the future.


Do you (or your child) have to take part?
No, you do not have to take part. However, before you make your final decision we would suggest that you find out more about the study by speaking to one of your local EcLiPSE team or speak to your (or child’s) paediatrician or neurologist.  

Why are you not asked prior to treatment?
The first priority is to treat you (or your child). We would not want to delay treatment by asking you to take part first.
 




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