Table 2.

Zonisamide in special populations

Study	Design	Patients	Intervention	Duration	Results
Guerrini et al., 2013 11	Phase 3 RCT Pediatric	183 patients aged 6–18 years with partial seizures	Zonisamide 1 mg/kg/day titrated to 8 mg/kg/day or placebo Adjunctive therapy	12 weeks	Response ratea: ITT population: LOCF: Zonisamide: 50%; placebo: 31%; P = 0.0044 OC: Zonisamide: 48%; placebo: 31%; P = 0.0143 PP: Zonisamide: 51%; placebo: 31%; P = 0.0046 Median reduction in 28‐day seizure frequency: Maintenance phase: Zonisamide: 50.0%; placebo: 24.5%; P < 0.0001 Titration and maintenance phase: Zonisamide: 42.2%; placebo: 20.4%; P < 0.0001 Seizure freedom during maintenance phase: Zonisamide: 14%; placebo: 3%; P = 0.0049
Guerrini et al., 2013 18 Guerrini et al., 2014 19	Long‐term open‐label extension to Guerrini et al., 2013 11 Pediatric	144 patients aged 6–18 years with partial seizures	Zonisamide 1–8 mg/kg/day Adjunctive therapy	45–57 weeks	108 patients (75.0%) received zonisamide for ≥1 year Mean dose: 7.5 mg/kg/day (standard deviation, 1.1 mg/kg/day; range, 3.8–10.6 mg/kg/day) Drug‐related TEAEs: 39 (27.1%) 92.3% were mild or moderate
Trinka et al., 2013 12	Pooled analysis Elderly	95 patients aged 65 years or older with partial seizures	Zonisamide 200 mg/day (range, 25–600 mg/day Monotherapy or adjunctive therapy	4.2 months (range, 0.1–18.4 months)	TEAE incidence: elderly: 82%; adult: 84% Drug‐related TEAEs: elderly: 56%; adult: 73% Severe TEAEs: elderly: 12%; adult: 21% Serious TEAEs: elderly: 13%; adult: 17% Serious treatment‐related TEAEs: elderly: 3%; adult: 7% TEAEs leading to withdrawal: elderly: 18%; adult: 23%

AED, antiepileptic drug; ITT, intent‐to‐treat; LOCF, last observation carried forward; OC, observed cases; PP, per protocol; RCT, randomized controlled trial; TEAE, treatment emergent adverse event.

^a≥50% reduction in seizure frequency.