The EpiNet–First group of trials
Trials will be open (unblinded) and pragmatic in design. Patients will be allocated to the different trials according to the type of seizures they experience. Patients will be followed for a minimum of 2 years.
The primary endpoint will be 12 months sustained seizure freedom.
The trials will commence in early 2015.
Patients will be
The EpiNet study group has received very little external funding for this trial. We are therefore not able to supply the drugs, and we will not provide funding to the different
The trials have been registered on the ANZCTR registry (Australia and New Zealand Clinical Trials Registry).
- People aged 5 years or older who have had two or more spontaneous seizures
- The investigator is confident that the diagnosis is epilepsy (at least an 80% level of confidence)
- Patients cannot previously have been treated with an AED for epilepsy for more than one week
- Patients must provide consent to participate in the trial. For patients younger than the age of consent (usually 16 years), patient’s parent / legal representative will need to give consent, and the patient should give assent (details may vary depending on country-specific requirements)
- Patients whose seizures were secondary to alcohol or recreational drugs
- Patients who have had acute symptomatic seizures (eg due to an acute stroke or acute head injury,
- Patients who have known progressive neurological disease (e.g glioma).
- Patients who have already received treatment with an AED for more than one week.
EpiNet–FirstTrial1 Patients with focal seizures will be randomised(1:1:1) to receive either levetiracetam or lamotrigine or carbamazepine. EpiNet–FirstTrial2 Patients with generalisedseizures will be randomised(1:1) to receive either sodium valproate or levetiracetam. EpiNet–FirstTrial3 If sodium valproate is deemed unsuitable (e.g. in women of childbearing age), then patients with generalisedseizures will be randomised(1:1) to either lamotrigine or levetiracetam. EpiNet–FirstTrial4 Patients with seizures of unknown nature will be randomised(1:1:1) to receive either levetiracetam, lamotrigine, or sodium valproate. EpiNet–FirstTrial5 If sodium valproate is deemed unsuitable (e.g. in women of childbearing age), then patients with seizures of unknown nature will be randomised(1:1) to levetiracetam orlamotrigine.
For the purposes of these
No clinical features to suggest focal seizures, and either
Generalisedspike and wave on EEG, or
- Myoclonic seizures, or
Generalised tonic clonicseizures alone with onset below age 30, provided that not all seizures have occurred from sleepIf someone has had a tonic clonicseizure, but these criteria are not met, then patients should be entered into one of the trials for patients with seizures of uncertain nature. In particularif it is unclear whether there may have been a focal onset to someone’s seizure, the seizure should be classified as “Epileptic seizure, uncertain if generalisedor focal”
Medication and dosing
All trial medication will be prescribed in a formulation and at a dose deemed suitable by the treating physicians. Generic versions of AEDs can be prescribed.
Follow-up data will be collected at 3, 6, 12, 18 and 24 months, and annually thereafter until the end of the trial. Patients need to be contacted at these times, though they do not necessarily need to be seen in a clinic.
Adult or child neurologists,
To be accredited as an investigator, physicians will need to meet the following conditions:
- agree to the principles underpinning the EpiNet collaboration. These are spelled out in the Memorandum of Understanding published on this site.
- demonstrate that they diagnose people with epilepsy, and diagnose focal and
generalisedseizures, in a similar way to other members of the EpiNet study group. This will involve participating in an accreditation process. (See below)
- demonstrate that they are familiar with
principlesof Good Clinical Practice (GCP). Anyone who is not yet familiar with GCP principles can undergo a tutorial here.
- undertake a tutorial which shows how the website works. Click here to go to the demonstration site. You can log in using the name “
epinetdemo” with the password ‘Ep1net’ (Note the upper-case ‘E’ and the numeral ‘1’). The tutorial can be found here.
We will also request that investigators send a copy of their CV to the coordinating
Investigators will need to obtain approval from their local ethics committee. The EpiNet team based in Auckland will be very happy to help with this process.
All investigators need to participate in an accreditation process to confirm that they diagnose people with epilepsy, and diagnose focal and
Click here to register.
Or contact the EpiNet administrator EpiNetAdmin@adhb.govt.nz for information regarding the accreditation process.
Data will be reviewed centrally by an independent data analyst to look for unusual patterns which might indicate erroneous or falsified data. Data from each
We expect that separate reports will be published for each of the five EpiNet–First trials. All papers will be written on behalf of the EpiNet study group. The writing group will be determined by the trial steering committee. All investigators who enter a patient who completes the minimum follow-up period into a trial will be listed in an appendix as one of the paper’s authors. The investigators who enter the most patients into each trial will have their names listed at the head of the relevant paper(s).
If you would like to participate in these trials, please register your interest here: