A review of safety and efficacy of zonisamide for treatment of pediatric partial epilepsy

Figures & data

Table 1 Clinical trials of zonisamide in pediatric patients with partial epilepsy

Authors	Nationality	Population (age)	Dose	Monotherapy/add-on	Efficacy	Adverse events (% of patients)
Randomized, placebo-controlled trials
Guerrini et al^Citation18	Europe, India	207 patients (aged 6–17 years), refractory partial-onset epilepsy	8 mg/kg/day (max: 500 mg/day)	Add-on	Responder rate =50.0% Seizure freedom =14.0%	55.1
Lu et al^Citation42	People’s Republic of China	102 patients (aged 18–70 years), refractory partial-onset epilepsy	300 or 400 mg/day	Add-on	300 mg responder rate =55.2% Seizure freedom = NA 400 mg responder rate =56.5% Seizure freedom = NA	78.9
Brodie et al^Citation39	Europe, South Africa	35 1 patients (aged 12-77 years), refractory partial-onset epilepsy	100, 300, or 500 mg/day	Add-on	100 mg responder rate =29.6% Seizure freedom = NA 300 mg responder rate =42.2% Seizure freedom = NA 500 mg responder rate =52.5% Seizure freedom = NA	100 mg group =67.9 300 mg group =70.9 500 mg group =81.4
Sackellares et al^Citation41	USA	152 patients (aged 17–67 years), refractory partial epilepsy	400-600 mg/day	Add-on	Responder rate =26.9% Seizure freedom = NA	70.5
Open-label trials
Guerrini et al^Citation21	Europe, India	144 patients (aged 6–18 years) refractory partial epilepsy	8 mg/kg/day (max: 500 mg/day)	Add-on	Responder rate =56.3% Seizure freedom = 16.0%	55.1
Wallander et al^Citation43	Sweden	75 patients (aged 0–17 years) with refractory partial or generalized epilepsy	6–8 mg/kg/day	Add-on	Responder rate =35% Seizure-freedom = NA	44.0
Eun et al^Citation31	Korea	125 patients (aged 3–15 years) with newly diagnosed partial or generalized epilepsy	3–4 to 6-8 mg/kg/day	Monotherapy	Responder rate = NA Seizure freedom =63.1% (low dose); 57.6% (high-dose)	NA
Shinnar et al^Citation22	Europe, USA	109 patients (aged 3-15 years), partial and generalized refractory epilepsy	8.5 mg/kg/day (mean dose)	Add-on	Median decrease in seizure frequency = 1.3% per week	NA
Coppola et al^Citation20	Italy	82 patients (aged 3-34 years), partial and generalized refractory epilepsy	5.7 mg/kg/day	Add-on	Responder rate =37.8% Seizure freedom = 10.9%	NA
Kluger et al^Citation19	Germany	24 patients (aged 2–40 years), 75% focal, 12.5% generalized, 12.5% refractory status epilepticus	7.7 mg/kg/day	Add-on	Responder rate =58.3% Seizure freedom =4.2%	46.0
Kothare et al^Citation30	USA	69 patients (mean age 13.2 years), 61% idiopathic generalized epilepsy, 4% symptomatic generalized epilepsy, 35% partial-onset epilepsy	4.9 mg/kg/day (range 2-13 mg/kg/day)	Monotherapy	Responder rate =75.4% Seizure freedom =67%	26.1
Kim HL et al^Citation33	USA	62 patients (aged 1–18 years), partial and generalized refractory epilepsy	5–10 mg/kg/day	Monotherapy and add-on	Responder rate =21 % Seizure freedom =25.8%	61.8
Wilfong^Citation32	USA	131 patients (aged 1–22) Partial and generalized refractory epilepsy	100-800 mg/day (max: 54 mg/kg/day)	Monotherapy	Responder rate =77.1 % Seizure freedom =29.8%	2.3
Seki et al^Citation29	Japan	77 patients (aged 8 months-15 years): – 44 patients with cryptogenic/symptomatic partial epilepsy – 11 patients with cryptogenic/symptomatic generalized epilepsy – 4 patients with idiopathic partial epilepsy – 9 patients with idiopathic generalized epilepsy	12 mg/kg/day	Monotherapy	Responder rate = NA Seizure freedom =79%	39.0

Abbreviation: NA, not available.

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