Epilepsy: pooled data from 17 clinical studies support safety of adjunctive Zonegran® (zonisamide) in children aged six and above
The safety profile of adjunctive Zonegran® (zonisamide) in paediatric patients with partial epilepsy is confirmed by pooled data published in the European Journal of Paediatric Neurology(EJPN).[i] These newly published safety data from 17 studies support zonisamide’s proven clinical efficacy in children aged six years and above.[ii],[iii] Zonisamide is indicated in Europe as adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged six years and above.[iv]
“Selection of the most appropriate treatment approach for children with epilepsy is a challenge as epileptic seizures can often impact a child’s neurological development, as well as physical well-being. This makes well-tolerated treatment options that can be used in this age group, such as zonisamide, valuable for doctors and patients alike,” commented Professor Helen Cross, Great Ormond Street Hospital and Young Epilepsy, UK.
It is estimated that there are 900,000 children and adolescents who live with active epilepsy in Europe.[v] Although epilepsy is common among this age group, only two thirds will achieve seizure control and many will require additional AEDs to improve seizure control.[vi] Epilepsy in children often presents major challenges such as developmental and behavioural problems which can result in educational underachievement and a lack of self-esteem. These issues, which are frequently manifested in an attention deficit disorder, withdrawal, anxiety or depression, have a negative impact on both the child and their family.[vii]
The pooled analysis includes 507 people aged ?16 years involved in four randomised, double-blind studies and 13 uncontrolled, open-label trials.[i] A total of 398 children received zonisamide and 109 received placebo. Most treatment emergent adverse events (TEAEs) were of mild or moderate intensity, the majority of which are already described in the safety profile for zonisamide. The most frequent treatment-related TEAEs were decreased appetite (15.6%), somnolence (12.1%), fatigue (9.3%), dizziness (6.0%), decreased weight (5.8%), irritability (5.8%) and headache (5.3%). The incidence of TEAEs that led to discontinuation was low 10.3%.[i]
Zonisamide has multiple mechanisms of action and a chemical structure unrelated to any other AED.[ii] The use of adjunctive zonisamide in the treatment of partial seizures (with or without secondary generalisation) in children aged six years and above was approved by the European Commission in October 2013.
[i] Cross H, et al. Safety and tolerability of zonisamide in paediatric patients with epilepsy. EJPN 2014. Available at: (accessed November 2014) DOI: 10.1016/j.ejpn.2014.07.005
[ii] Guerrini R. et al. A randomized, phase III trial of adjunctive zonisamide in pediatric patients with partial epilepsy. Epilepsia. 2013:54(8):1473-80
[iii] Guerrini R, et al. Adjunctive zonisamide therapy in the long-term treatment of children with partial epilepsy: Results of an open-label extension of a phase III, randomised, double-blind, placebo-controlled trial. Epilepsia. 2014:55(4):568-578
[iv] Zonegran, Summary of Product Characteristics (updated October 2013): http://www.medicines.org.uk/emc/medicine/16240/
[v] Forsgren L. et al. The epidemiology of epilepsy in Europe – a systematic review. European Journal of Neurology 2005:12(4)245-253
[vi] Epilepsy Society. Medication for children. http://www.epilepsysociety.org.uk/AboutEpilepsy/Treatment/Medicationforchildren (accessed September 2014)
[vii] Sabbagh S, et al. Impact of epilepsy characteristics and behavioral problems on school placement in children. Epilepsy & Behavior 2006:(9)573-578
[viii] Data on file: ZON2013-0003. Eisai Europe Ltd.
[ix] Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf (accessed September 2014)
[x] Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007:48(12):2224-2233.