drugset / Trial / NCT00203242

An Open Label Study Using Consecutive Intravenous Depacon With Oral Depakote ER for the Treatment of Cluster Headaches.

NCT00203242

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to collect and evaluate information on the use of Depakote Extended Release (ER) and Depacon Intravenous (IV) in patients with cluster headaches. Patients who are currently in a cluster cycle will be treated with 2 consecutive days of IV Depacon followed by oral Depakote ER. Patients will receive a total of 1,000mg of Depacon and 1,000mg of Depakote ER each day. Patients may have a 3rd day of IV Depacon followed by oral Depakote ER if the primary investigator believes it to be beneficial. The patient is then sent home on oral Depakote ER. The dose of Depakote ER can range from 500mg to 2,000mg this dose is to be determined by the primary investigator. The patient will continue the oral Depakote ER until the end of their cluster cycle or for a maximum of 6 weeks, which ever comes first.

Timeline

Start
2003-07
Primary completion
2006-09
Completion
2006-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Valproate Small molecule 1000 mg Intravenous
Subject Valproate Small molecule 1000 mg Oral
Subject Valproate Small molecule 2000 mg Oral