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Clinical Trials

Depakote (divalproex sodium)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved March 1996

Specific Treatments:

migraine headaches

General Information

Depakote tablets have been approved for the prevention of migraine headaches.

Clinical Results

The results of two double-blind, placebo-controlled, multicenter trials established the efficacy of Depakote in reducing the incidence of migraine headaches. Both studies consisted of a four-week initial phase, during which subjects were monitored to determine migraine headache frequency, and a 12-week treatment phase. Slightly less than half of Depakote-treated subjects showed reduction in migraine frequency.

Side Effects

Depakote was generally well tolerated in the two clinical trials. Most frequent adverse events reported by patients receiving Depakote were nausea, dyspepsia, diarrhea, vomiting, weakness, fatigue, sleepiness, and dizziness. Events leading to discontinuation included hair loss, nausea, vomiting, weight gain, and tremor.

Other safety considerations include hepatic failure, which has resulted in fatalities in subjects receiving valproic acid and its derivatives, usually in the first six months of treatment. Valproic acid can produce teratogenic effects in the offspring of women receiving the drug during pregnancy. Divalproex sodium is a derivative of valproic acid. The use of Depakote tablets for migraine prophylaxis in women of childbearing potential requires that the benefits of its use be weighed against the risk of injury to the fetus.

Additional Information

Approximately 23 million Americans suffer from migraine headaches. Of those, approximately 11 million suffer moderate to severe migraines that are disabling. Migraine headaches are characterized by intense, recurrent pain on one or both sides of the head, and usually are accompanied by one or more concurrent symptoms, including nausea, vomiting, and an increased sensitivity to noise and/or bright light.

Treatment for migraine may involve acute therapies, which are taken by the subject at the onset of a migraine, or preventive treatments, which may involve daily drug therapy.

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