Safety of 25- and 50-mg capsules in the initiation of zonisamide therapy in patients with epilepsy: an uncontrolled, open-label study.
OBJECTIVE
This study was designed to assess the safety of 25- and 50-mg dosage strengths of zonisamide for initial titration in patients with epilepsy.


METHODS
This phase 3, multicenter, open-label, uncontrolled study conducted at 26 study sites in the United States included male and female patients with epilepsy >or= 12 years of age. After a screening visit, subjects began zonisamide therapy at a dosage depending on their body weight. Zonisamide was titrated to 100 mg/day.


METHODS
At the study's conclusion, information regarding adverse events (AEs) and body weight was recorded.


RESULTS
One hundred forty-three subjects enrolled and received at least one zonisamide dose. Of these subjects, 125 reached at least the 100-mg dosage before terminating the study. Eighty-two subjects (57.3%) experienced at least one AE. Most commonly reported AEs included headache, somnolence, asthenia, rhinitis, nausea, and rash. No significant change in patient body weight was noted during the study (95% confidence interval: -0.1, 0.6).


CONCLUSIONS
Study limitations include the open-label design and the lack of direct comparison between lower (25- and 50-mg) and higher (100-mg) starting dosages. Despite these limitations, the 25- and 50-mg zonisamide dosage formulations were well tolerated in this study.
Uthman
Basim M
BM
Malcom Randall Department of Veterans Affairs Medical Center; University of Florida College of Medicine and the McKnight Brain Institute, Gainesville, FL 32608, USA. basim.uthman@med.va.gov
Miller
G Steven
GS
Montouris
Georgia
G
James
Steven P
SP
Anthony
Stacy
S
D000328:Adult; D000927:Anticonvulsants; D004305:Dose-Response Relationship, Drug; D004827:Epilepsy / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D014481:United States; D000078305:Zonisamide
D000927:Anticonvulsants; D007555:Isoxazoles; D000078305:Zonisamide