Status:
COMPLETED
An Open Label Study Using Consecutive Intravenous Depacon With Oral Depakote ER for the Treatment of Cluster Headaches.
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
Abbott
Conditions:
Cluster Headache
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 currentl...
Detailed Description
This study will consist of four visits (3 visits if the screening visit and first treatment visit are on the same day). Screening Visit: The screening visit can be performed either before an active ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00203242
Start Date
July 1 2003
End Date
December 1 2006
Last Update
July 15 2011
Active Locations (1)
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1
Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107