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A randomized, placebo‐controlled study of oxcarbazepine in painful diabetic neuropathy
Author(s) -
Grosskopf J.,
Mazzola J.,
Wan Y.,
Hopwood M.
Publication year - 2006
Publication title -
acta neurologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.967
H-Index - 95
eISSN - 1600-0404
pISSN - 0001-6314
DOI - 10.1111/j.1600-0404.2005.00559.x
Subject(s) - oxcarbazepine , medicine , placebo , adverse effect , diabetic neuropathy , anesthesia , randomized controlled trial , visual analogue scale , diabetes mellitus , epilepsy , carbamazepine , endocrinology , alternative medicine , pathology , psychiatry
Objectives: To evaluate the efficacy and safety of oxcarbazepine (1200 mg/day) in patients with painful diabetic neuropathy in a multicentre, double‐blind, placebo‐controlled, 16‐week study. Methods: A total of 141 patients were randomized to oxcarbazepine (1200 mg/day) ( n = 71) or placebo ( n = 70). The primary efficacy variable was the change in mean visual analogue scale (VAS) score from baseline to the last week the patient participated in the study. Results: The reduction in mean VAS score from baseline to the last study week was similar between the oxcarbazepine and placebo groups. The majority of adverse events (most of which first occurred during titration) were mild to moderate in severity and resolved over the course of the study. Conclusions: In this study, no statistically significant difference in therapeutic effect was observed between oxcarbazepine (1200 mg/day) and placebo. However, further studies are necessary to assess the effective dose range of oxcarbazepine in the treatment of painful diabetic neuropathy.