PMID- 15200740
OWN - NLM
STAT- MEDLINE
DCOM- 20040921
LR  - 20181130
IS  - 0300-7995 (Print)
IS  - 0300-7995 (Linking)
VI  - 20
IP  - 6
DP  - 2004 Jun
TI  - Safety of 25- and 50-mg capsules in the initiation of zonisamide therapy in 
      patients with epilepsy: an uncontrolled, open-label study.
PG  - 837-42
AB  - 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. RESEARCH 
      DESIGN AND 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. MAIN OUTCOME MEASURES: 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.
FAU - Uthman, Basim M
AU  - Uthman BM
AD  - 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
FAU - Miller, G Steven
AU  - Miller GS
FAU - Montouris, Georgia
AU  - Montouris G
FAU - James, Steven P
AU  - James SP
FAU - Anthony, Stacy
AU  - Anthony S
CN  - Zonisamide 501 Study Group
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Anticonvulsants)
RN  - 0 (Isoxazoles)
RN  - 459384H98V (Zonisamide)
SB  - IM
MH  - Adult
MH  - Anticonvulsants
MH  - Dose-Response Relationship, Drug
MH  - Epilepsy/*drug therapy
MH  - Female
MH  - Humans
MH  - Isoxazoles/*administration & dosage/adverse effects/therapeutic use
MH  - Male
MH  - United States
MH  - Zonisamide
EDAT- 2004/06/18 05:00
MHDA- 2004/09/24 05:00
CRDT- 2004/06/18 05:00
PHST- 2004/06/18 05:00 [pubmed]
PHST- 2004/09/24 05:00 [medline]
PHST- 2004/06/18 05:00 [entrez]
AID - 10.1185/030079904125003629 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2004 Jun;20(6):837-42. doi: 10.1185/030079904125003629.