At a glance
ClinicalIndex Comparison Record- ✓Age 18–65 years old
- ✓Diagnosis of episodic or chronic cluster headache per International Headache Society criteria
- ✓Lifetime history of at least 2 cluster periods
- ✓Current or anticipated cluster period duration of at least 6 weeks from start of treatment
- ✕History or evidence of hepatic disease including hepatitis, liver failure, or LFTs >3× upper limit of normal
- ✕Allergy or hypersensitivity to valproate or valproic acid
- ✕Significant drug or alcohol abuse within the past year
- ✕Use of corticosteroids or nerve blocks within 4 weeks prior to treatment start
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label Pilot Study to Collect/Evaluate Data on the Use of Consecutive Daily Intravenous Doses of Depacon in Combination With Daily Dose of Depakote ER During a Cluster Headache Cycle.
In Brief
A clinical study evaluating Depacon IV and Depakote ER for Cluster Headache. Completed, enrolled 15 participants across 1 site.
Detailed 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.