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Open label pilot study of oxcarbazepine for inpatients under evaluation for epilepsy surgery
Author(s) -
Fisher Robert S.,
Eskola Jennifer,
Blum David,
Kerrigan John F.,
Drazkowski Joseph,
Duncan Bonnie
Publication year - 1996
Publication title -
drug development research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.582
H-Index - 60
eISSN - 1098-2299
pISSN - 0272-4391
DOI - 10.1002/(sici)1098-2299(199605)38:1<43::aid-ddr5>3.0.co;2-l
Subject(s) - oxcarbazepine , medicine , carbamazepine , adverse effect , epilepsy , anesthesia , open label , nausea , open label study , psychiatry
Oxcarbazepine (OXC) is a keto analogue of carbamazepine with no epoxide metabolite. We performed an open‐label pilot study of OXC in six men and four women undergoing presurgical evaluation for complex partial or secondarily generalized seizures. Mean age was 34.3 ± 8.3 years, and mean duration of epilepsy was 18.2 ± 11.1 years. Patients were monitored for approximately 7 days before entry into an open‐label add‐on OXC study. Baseline antiepileptic medications were stopped in seven of the ten patients prior to initiating OXC. OXC was titrated to 2,400 mg/day in two divided doses over 2–3 days. The baseline daily seizure frequency was 0.75 ± 0.49, compared to 0.19 ± 0.31 seizures per day during the 10 days subjects were on OXC ( P = .04, two‐tailed paired t test). Overall, 80% of patients showed at least a 50% reduction in seizures, and the mean reduction was to 32% of the baseline. Adverse events consisted of nausea (20%), ataxia (10%), fatigue (10%), blurred vision (10%), and pruritus (10%). Segmented neutrophil counts, serum sodium, and serum AST declined with OXC. This pilot study suggests preliminary evidence for safety and efficacy of OXC. © 1996 Wiley‐Liss, Inc.