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The Efficacy of Divalproex Sodium in the Prophylactic Treatment of Children With Migraine (Posted Nov 2000)

Divalproex Sodium in the Preventative Treatment of Cluster Headache (Posted July 2000)

Divalproex Sodium in the Preventative Treatment of Cluster Headache

To study the efficacy and safety of divalproex sodium in cluster headache.

This was a long term, open label, variable dose study to assess divalproex sodium in the preventative treatment of both episodic and chronic cluster headache. Patients were not allowed concomitant preventative treatment. Acute treatment of cluster attacks was allowed provided that patients were utilizing analgesic, ergots or triptan agents less than 3 days per week.

21 of 26 patients experienced chronic cluster headache (CC). The remainder had episodic cluster headache. Those with episodic cluster headache (EC) had relative contraindications to more standard medical therapies. There were 15 males and 6 females with CC and 3 males and 2 females with EC. Mean age of CC patients was 43.4 years and 51.6 years for EC. The mean decrease in headache frequency per 28 day period was 53.9% for CC and 58.6% for EC. CC patients averaged 11.1 months of treatment with nonresponders being discontinued after a mean of 5.2 months. EC patients were treated for 2 weeks after the last cluster attack before a stepwise dose reduction and discontinuation. The mean dose of divalproex sodium in EC was 850 mg. per day. In CC the mean dose was 826 mg. per day. Responders to treatment average 750 mg. per day for EC and 719 mg. per day for CC. 5 Patients experienced adverse events of rash, hair loss, tiredness, nausea and tremor. None of the patients had weight gain in excess of 3 pounds. There were no adverse events in patients with EC.

Divalproex sodium appears to be an agent with substantial benefit as a sole drug treatment for CC. In EC there appears to be potential as an alternative treatment to more standard medical therapies.