| Trial name or title | A study to investigate the safety of the drugs topiramate and levetiracetam in treating children recently diagnosed with epilepsy |
| Methods | Phase 3, randomised, open‐label, parallel‐group trial conducted in multiple centres in the USA, South America, Asia and Europe 2 treatment arms: LEV and TPM |
| Participants | Participants with a clinical diagnosis of new‐onset or recent‐onset epilepsy characterised by partial‐onset seizures (with or without secondary generalisation) or primary generalised tonic‐clonic seizures with no previous treatment for epilepsy (except emergency treatment) Estimated enrolment = 282 |
| Interventions | Monotherapy with LEV or TPM Maximum recommended doses: LEV = 3000 mg/d, TPM = 400 mg/d |
| Outcomes | Percentage of participants with kidney stones Change from baseline in weight Z‐score at month 12 Change from baseline in height at month 12 Change from baseline in bone mineral density (BMD) at Month 12 (other measures of weight, height and bone density specified on trial registration page) |
| Starting date | October 2014 |
| Contact information | Janssen Research & Development |
| Notes | Trial registered as NCT012201251 on ClincalTrials.gov and listed as currently recruiting participants (correct to August 2016). Estimated finishing date is March 2018. |
Abbreviations: AED: antiepileptic drug; CBZ: carbamazepine; LEV: levetiracetam; LTG: lamotrigine; OXC: oxcarbazepine; VPS: sodium valproate; TPM: topiramate