Randomized, Controlled Clinical Trial of Zonisamide as Adjunctive Treatment for Refractory Partial Seizures
| Autor: | M. Kent Shellenberger, Thomas R. Browne, B. Joseph Wilder, R. Eugene Ramsay, J. Chris Sackellares |
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| Rok vydání: | 2004 |
| Předmět: |
Adult
Male Adolescent Nausea Health Status Zonisamide Drug Administration Schedule law.invention Placebos Epilepsy Double-Blind Method Randomized controlled trial Refractory law medicine Humans Adverse effect Aged Dose-Response Relationship Drug business.industry Isoxazoles Middle Aged medicine.disease Clinical trial Treatment Outcome Neurology Anesthesia Adjunctive treatment Anticonvulsants Drug Therapy Combination Female Epilepsies Partial Neurology (clinical) medicine.symptom business medicine.drug |
| Zdroj: | Epilepsia. 45:610-617 |
| ISSN: | 1528-1167 0013-9580 |
| DOI: | 10.1111/j.0013-9580.2004.11403.x |
| Popis: | Summary: Purpose: This study was designed to evaluate efficacy and safety of zonisamide (ZNS) as adjunctive treatment for patients with refractory partial seizures. Methods: This randomized, double-blind, placebo-controlled study was conducted at four epilepsy treatment centers. It included a baseline phase (8 to 12 weeks) and a double-blind treatment phase (12 weeks). Initially, patients randomized to ZNS treatment were given a 7-mg/kg/d dosage. When investigators found that adverse effects could be reduced by gradually introducing ZNS, patients were allowed to begin treatment at lower doses (100 mg or ∼1.5 mg/kg/d) titrated over several weeks to a maximum of 400 to 600 mg/d. Primary and secondary efficacy measures were the median percentage reduction from baseline in seizure frequency and the proportion of patients achieving a ≥50% reduction from baseline (responder rate). Patient and physician global assessments also served as indicators of efficacy. Safety was assessed primarily by treatment-emergent adverse events. Results: ZNS-treated patients had a 28.9% reduction in seizure frequency, which differed significantly from the 4.7% increase in placebo-treated patients. The responder rate for ZNS-treated patients was 26.9%, compared with 16.2% for placebo-treated patients. At study’s end, 66.2% of ZNS-treated patients and 12.3% of placebo-treated patients considered their condition improved; similarly, physicians assessed 63.6% of ZNS-treated patients and 10.8% of placebo-treated patients as improved. The most frequently reported adverse events with ZNS treatment included somnolence, irritability, dizziness, nausea, and fatigue. Conclusions: As adjunctive treatment, ZNS was generally well tolerated and significantly improved seizure control among patients with refractory partial seizures. Key Words: Zonisamide—Antiepilepsy drug—Epilepsy—Partialonset seizures—Randomized controlled trial. |
| Databáze: | OpenAIRE |
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