PERsonalised Selection Of medication for Newly diagnosed Adult epiLepsy - the PERSONAL Trial
- Conditions
- EpilepsyNeurological - Epilepsy
- Registration Number
- ACTRN12623000209695
- Lead Sponsor
- Monash University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 234
Diagnosis of epilepsy consistent with International League against Epilepsy (ILAE) criteria, defined as either:
(1) at least two seizures within the past 12 months,
or (2) one seizure within the past 6 months and epileptiform discharges on electroencephalography (EEG), or presence of epileptogenic lesion on computed tomography (CT) or magnetic resonance imaging (MRI)
- EEG and MRI brain done with 6 months prior to randomisation (MRI can be substituted with epileptogenic lesion shown on CT)
- Either naive to anti-seizure medication (ASM) treatment or has been treated with a single ASM for 14 days or less before randomisation
- Previously treated epilepsy or current use of ASM for any reason for more than 14 days
- Pregnant or breast-feeding
- Current substance abuse disorder that may affect treatment adherence or response
- Unable/failed to undergo EEG or brain CT or MRI due to contraindication
- Patient with psychogenic non-epileptic seizures
- Patients with progressive central nervous system disease, series hepatic or renal disease, or terminal cancer that would affect the assessment of response to ASMs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients who are seizure-free while taking the first anti-seizure medication assessed through use of a participant seizure diary that is reviewed at each of the epilepsy clinic visits.[ Assessed for any seizures at each of the study site visits up to 52-weeks post intervention commencement]
- Secondary Outcome Measures
Name Time Method