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Safety and Efficacy of Depakote ER in Pediatric
Migraine Prophylaxis
Vu KT, Thompson N, Mills S
Posted: March 2003  
Headache Quarterly 2002; 13.3:28

Objective:   To evaluate the safety and efficacy of divalproex sodium extended-release (ER) when used as a prophylactic monotherapy in pediatric patients with migraine.

Patients:   Twenty-two pediatric patients (age range:11-19 years) who satisfied the IHS criteria for migraine headache, and who had more than two migraine headaches per month. The patients were placed on divalproex sodium ER once daily at bedtime. These patients were either previously untreated (16 patients) or had previously failed no more than one adequate trial of prophylactic therapy.

Main Outcome Measures:   The frequency, duration, and/or severity of migraine attacks were compared for each 2-month follow-up period. Side effects were recorded.

Results:   Seventy percent have more than a 50 percent reduction in frequency of headaches, and all reported less disabling migraine attacks after 4 weeks in therapy. The same improvement was maintained in patients who have been followed for a period of 3 to 12 months. Increased appetite was the most frequent complaint among these patients, although none had significant weight gain.

Conclusion:   Divalproex sodium ER is safe and efficacious for pediatric migraine prophylaxis.