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

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Jefferson University
• Collaborator: Abbott
• Treatments: Valproic Acid

Criteria

Inclusion Criteria:

• Subjects between the ages of 18 and 65 with a diagnosis of cluster headache (episodic or chronic) as defined by the International Headache Society criteria

• Subject is using or agrees to use for the duration of participation a medically acceptable form of contraception (as determined by investigator), if female of child-bearing potential

• Subject has negative urine pregnancy test prior to study entry (Screening and Infusion Day 1), if female of child-bearing potential

• Subject is able to understand and comply with all study requirements

• Subject provides written informed consent prior to any screening procedures being conducted

Exclusion Criteria:

• Women who are pregnant or lactating

• Subjects who have a lifetime history of less than 2 cluster periods

• Subjects who have a typical cluster period of less than 6 weeks duration, or are currently in a cluster period that is expected to last less than 6 weeks from Infusion Day 1

• Subjects who have or have a history of hepatic conditions (such as hepatitis, liver failure or liver function tests (LFT's) greater than three times normal)

• Subjects who, in the investigators opinion, have a history or have evidence of a medical or psychiatric condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability during this trial

• Subjects who require a change in medication or existing regimen of medication in the 4 weeks prior to Infusion Day 1 and for the duration of the trial

• Subjects who require a change in medication or existing regimen of medication for the prophylaxis of cluster in the 4 weeks prior to Infusion Day 1 and for the duration of the trial

• Subjects who have used the following medications/ treatments from four weeks prior to Infusion Day 1: corticosteroids and nerve blocks.

• Subjects who are allergic to or have shown hypersensitivity to valproate or valproic acid

• Subjects with a history of significant drug or alcohol abuse within the past year

• Subjects who have participated in an investigational drug trial in the 30 days prior to the screening visit

• Subjects who have failed previous trials of Depakote or Depacon for the treatment of cluster headache