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

Sponsor:	Thomas Jefferson University
Collaborator:	Abbott
Information provided by:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00203242

Purpose

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.

Condition	Intervention
Cluster Headache	Drug: Depacon IV and Depakote ER

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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.

Resource links provided by NLM:

MedlinePlus related topics: Headache

Drug Information available for: Divalproex sodium Valproic acid Valproate Sodium

U.S. FDA Resources

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:

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. [ Time Frame: baseline (day 0) through 47 days after first infusion ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

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. [ Time Frame: Compare Baseline through 47 days ] [ Designated as safety issue: No ]
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. [ Time Frame: Baseline compared to maintenance (up to 47 days) ] [ Designated as safety issue: No ]

Enrollment:	15
Study Start Date:	July 2003
Study Completion Date:	December 2006
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Depacon IV and Depakote ER 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

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Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203242

Locations

United States, Pennsylvania
Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Thomas Jefferson University

Abbott

Investigators

Principal Investigator:

Stephen D Silberstein, MD

Thomas Jefferson University, Jefferson Headache Center

More Information

No publications provided

Responsible Party:	Stephen D. Silberstein, M.D.- Principal Investigator, Thomas Jefferson University/Jefferson Headache Center
ClinicalTrials.gov Identifier:	NCT00203242 History of Changes
Other Study ID Numbers:	SDS/DEP/01
Study First Received:	September 13, 2005
Results First Received:	June 7, 2011
Last Updated:	July 13, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Cluster Headache
Headache
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Valproic Acid
Anticonvulsants

Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 13, 2012