← Back to Search

Anticonvulsant

Depacon IV and Depakote ER for Cluster Headache

N/A
Waitlist Available
Led By Stephen D Silberstein, MD
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 0) through 47 days after first infusion
Awards & highlights

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.

Eligible Conditions
  • Cluster Headache

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 0) through 47 days after first infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 0) through 47 days after first infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time Required to Achieve a Greater Than or Equal to 50% Reduction in Frequency or Severity of Individual Cluster Attacks Compared to Subject-reported Baseline.

Side effects data

From 2021 Phase 4 trial • 88 Patients • NCT03012815
2%
Allergic reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gabapentin
Benzodiazepine

Trial Design

1Treatment groups
Experimental Treatment
Group I: Depacon IV and Depakote ERExperimental Treatment1 Intervention
Subjects will be treated in this single arm study with 2 consecutive days of IV Depacon followed by oral Depakote ER for a total of 1000 mg of Depacon and 1000 mg of Depakote ER each day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Valproic acid
FDA approved

Find a Location

Who is running the clinical trial?

AbbottIndustry Sponsor
752 Previous Clinical Trials
478,147 Total Patients Enrolled
Thomas Jefferson UniversityLead Sponsor
457 Previous Clinical Trials
150,161 Total Patients Enrolled
2 Trials studying Cluster Headache
101 Patients Enrolled for Cluster Headache
Stephen D Silberstein, MDPrincipal InvestigatorThomas Jefferson University, Jefferson Headache Center
5 Previous Clinical Trials
141 Total Patients Enrolled
~1 spots leftby Sep 2025