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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 June 1996

Specific Treatments:


General Information

Depakote has been approved for the treatment of complex partial seizures (CPS), a common type of epilepsy. This is a new indication for Depakote, which has already been approved for the treatment of migraine headaches. The new indication for treatment of CPS includes using Depakote as a sole agent (monotherapy) or as adjunctive therapy for use with other anti-epilepsy drugs. Both Depakote tablets and sprinkle capsules can be used for treatment.

Clinical Results

Depakote-treated subjects showed significant improvement by reducing seizure frequency. This improvement was established in clinical trials with Depakote as adjunctive or monotherapy conducted with subjects who continued to experience seizures while taking their current epilepsy medication. Seizure frequency was calculated to reflect the median number of seizures during an eight-week measurement period versus an eight-week treatment period with Depakote.

Side Effects

In clinical trials, Depakote was generally well tolerated. Most adverse events were mild to moderate in severity. Common adverse events were nausea, tremor, somnolence, vomiting, asthenia, abdominal pain, and anorexia. Other important safety considerations include the possibility of hepatic failure, which has resulted in fatalities in subjects receiving valproic acid and its derivatives, usually occurring during the first six months of treatment. Valproic acid may produce teratogenic effects in the offspring of women receiving the drug during pregnancy, Thrombocytopenia, an abnormally low number of platelets in the blood, has also been associated with Depakote use. The incidence of thrombocytopenia appears to be dose related.

Additional Information

Approximately 2.5 million people in the United States have some form of epilepsy and an estimated 125,000 new cases are diagnosed each year. Depakote has been marketed in the United States since 1983 as a treatment for simple and complex absence seizures.

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