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

NCT00203242 | Completed Results

• 1 other identifier: SDS/DEP/01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Cluster Headache

Outcome Measures

Primary Outcomes (1)

• 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.

  Severity: measured on an 11 point scale, where 0 = no pain and 10= excruciating pain. Outcome is time to 50% reduction in severity (or frequency) compared to baseline (prior to treatment).Frequency: Number of attacks per day.The Time to significant response was measured 2 ways: significant initial response and significant maintained response. For initial response, the time to significant response was: Mean of 2.1(1.5) days for severity and 1.9 (1.6) days for frequency. The time to significant response maintained was 29.7 (13.8) for severity and 29.0 (14.3) for frequency.

  baseline (day 0) through 47 days after first infusion

Secondary Outcomes (2)

• Change in Frequency of Attacks Per 24 Hour Period, Duration of Individual Attacks (in Minutes), or Severity of Attacks Compared to the Subject-reported Baseline Values.

  Compare Baseline through 47 days

• Use of Acute and Rescue Medications During Loading (2 Days) and Maintenance Phases as Compared to Subject-reported Baseline. This Will be Calculated Using the Total Number of Doses of Acute Medications Per 24-hour Period Calendar Days.

  Baseline compared to maintenance (up to 47 days)

Study Arms (1)

Depacon IV and Depakote ER

EXPERIMENTAL

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.

Drug: Depacon IV and Depakote ER

Interventions

Depacon IV and Depakote ER DRUG

Depacon IV and Depakote ER

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Abbott: collaborator

Study Sites (1)

Jefferson Headache Center

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Cluster Headache

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Results Point of Contact

• Title: Stephen D. Silberstein-Principal Investigator
• Organization: Thomas Jefferson University/Jefferson Headache Center

Stephen.Silberstein@jefferson.edu

215-955-9477

Study Officials

• Stephen D Silberstein, MD

  Thomas Jefferson University, Jefferson Headache Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: July 1, 2003
• Primary Completion: September 1, 2006
• Study Completion: December 1, 2006
• Last Updated: July 15, 2011
• Results First Posted: July 6, 2011

Record last verified: 2011-07

Locations

US (1)