Trial reportClinical drug investigation2011
Efficacy and safety of adjunctive zonisamide in adult patients with refractory partial-onset epilepsy: a randomized, double-blind, placebo-controlled trial.
Trial report in Clinical drug investigation, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 3 syntheses or guidelines pooled it, 27 citations in OpenAlex.
- Zonisamide add-on therapy for focal epilepsy.The Cochrane database of systematic reviews · 2020Pooled it
- Zonisamide add-on therapy for focal epilepsy.The Cochrane database of systematic reviews · 2018Pooled it
- Investigation of influencing factors on higher placebo response in East Asian versus Western clinical trials for partial epilepsy: a meta-analysis.Clinical drug investigation · 2013Pooled it
- A randomized, double-blind, placebo-controlled, dose-escalating phase IIa trial to evaluate the safety, tolerability, efficacy, and pharmacokinetics of multiple oral doses of Pynegabine tablets as add-on therapy in patients with focal epilepsy.CNS neuroscience & therapeutics · 2024Trial
- Efficacy and safety of add-on antiseizure medications for focal epilepsy: A network meta-analysis.Epilepsia open · 2024Article
- Zonisamide: A Comprehensive, Updated Review for the Clinician.Neurology. Clinical practice · 2024Review
- Clinical Trial Design for Disease-Modifying Therapies for Genetic Epilepsies.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2021Review
- A meta-analysis: efficacy and safety of anti-epileptic drugs prescribed in Korea as monotherapy and adjunctive treatment for patients with focal epilepsy.Translational and clinical pharmacology · 2021Article
- Efficacy and Tolerability of Second and Third Generation Anti-epileptic Drugs in Refractory Epilepsy: A Network Meta-Analysis.Scientific reports · 2017Article
- A comprehensive review of the literature on epilepsy in selected countries in emerging markets.Neuropsychiatric disease and treatment · 2011Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveClinical studies have reported that zonisamide is effective for a wide range of seizure types, including refractory partial-onset seizures. However, there have been no reported studies of the efficacy of zonisamide in the Chinese population to date. The aim of the present study was to evaluate the efficacy and safety of zonisamide in the treatment of adult Chinese patients with refractory partial-onset epilepsy.
methodsThis was a randomized, double-blind, placebo-controlled trial conducted over a 16-week period. 104 patients with refractory partial-onset epilepsy were enrolled. Participants were randomly assigned to receive add-on zonisamide or placebo. Zonisamide was titrated to a target dosage of 300 or 400 mg/day. Seizure frequency and adverse effects were documented.
results102 patients completed the trial. Zonisamide showed significantly greater efficacy compared with placebo (responder rate 55.8% vs 36.0%, p<0.05), including 55.2% (16 of 29 patients) in the zonisamide 300 mg/day arm and 56.5% (13 of 23 patients) in the zonisamide 400 mg/day arm. Zonisamide 300 and 400 mg/day showed similar efficacy (p>0.05). Moreover, similar efficacy of zonisamide was found in the control of complex partial seizures, simple partial seizures and secondary generalized seizures. There was no difference in the incidence of adverse effects between zonisamide and placebo. Reported adverse effects in the zonisamide group involved the digestive system (32.5% of total adverse effects in the group) [including transient increases in liver enzymes (27.8%)], weight changes (30.2%), the haematological system (15.1%), neurological/psychiatric effects (10.3%), the urinary system (7.9%) and the cardiovascular system (4.0%). Only digestive system adverse effects constituted a significantly higher proportion of adverse effects in the zonisamide group than in the placebo group (32.5% vs 30.2%, p<0.05).
conclusionZonisamide 300-400 mg/day is effective and well tolerated as an adjunctive drug in adult Chinese patients with refractory partial-onset epilepsy.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.