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A Randomized Trial of Divalproex Sodium
Extended-Release Tablets in Migraine Prophylaxis
Freitag FG, Collins SD, Carlson HA, et al
Posted: April 2003  
Neurology 2002; 58:1652-1659

Objective:   To evaluate the efficacy and safety of extended-release divalproex sodium compared with placebo in prophylactic monotherapy treatment of migraine headache.

Methods:   This was a double-blind, randomized, placebo-controlled, parallel-group study. Subjects with more than two migraine headache attacks during a 4-week baseline were randomly assigned in a 1:1 ratio at each center to receive either extended-release divalproex sodium or matching placebo once daily for 12 weeks. Subjects initiated treatment on 500 mg. once daily for 1 week, and the dose was then increased to 1,000 mg. once daily with an option, if intolerance occurred, to permanently decrease the dose to 500 mg. during the second week. Reduction from baseline in 4-week migraine headache rate was the primary efficacy variable. Tolerance and safety were also evaluated.

Conclusion:   Reductions with extended-release divalproex sodium were significantly greater than with placebo in all three 4-week segments of the treatment period. No significant differences were detected between treatment groups in either the overall incidence or in the incidence of any specific treatment-emergent adverse event; 8 percent of subjects treated with extended-release divalproex sodium, and 9 percent of those treated with placebo discontinued for adverse events.

Conclusions:   Extended-release divalproex sodium is an efficacious, well-tolerated, safe, and easy-to-use once-a-day prophylactic antimigraine medication.