Table 3

Schedule of follow-up

ProceduresBaseline (T0)*Follow-up schedule
T0+3 monthsT0+6 monthsT0+12 months and annually thereafter
Signed consent formX
Assessment of eligibility criteriaX
Contact detailsX
Review of medical history including:X
  • Seizure history

  • Neurological insult

  • Febrile seizures

  • Family history of epilepsy

  • EEG results

  • Imaging results (CT or MRI)

Further investigation (EEG/CT/MRI)(X)
Allocation of study treatmentX
Issue of questionnaires in person or by postXXXX
Review of seizure occurrence and hospital admissionsXXX
Review of AED use (study treatment and concomitant):
  •  Since last follow-up

XXX
  •  Changes made to treatment plan including reasons

Assessment of adverse reactions(X)(X)(X)
Resource useXXX
Reissue of questionnaire by post or at site to non-responders typically 3 weeks later(X)(X)(X)(X)
Telephone follow-up of questionnaire non-responders typically 3 weeks later(X)(X)(X)(X)
Special assay or procedure consent and obtain saliva or blood sample for later DNA analysisConsent and obtain saliva or blood sample for later DNA analysis(X)
  • (X)—as indicated/appropriate.

  • EEG = Electroencephalogram

  • *At baseline, all procedures should be done before study intervention.

  • AED, antiepileptic drug.