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

This study has been completed.

Study NCT00203242 Information provided by Thomas Jefferson University

First Received on September 13, 2005. Last Updated on July 13, 2011 History of Changes

Results First Received: June 7, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Cluster Headache
Intervention:	Drug: Depacon IV and Depakote ER

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Depacon IV and Depakote	Subjects will be treated with 2 consecutive days of IV Depacon (1000 mg/day) followed by oral Depakote ER (1000 mg/day). Subject continues oral Depakote ER until end of cluster cycle or for a maximum of 6 weeks, which ever comes first.

Participant Flow: Overall Study

	Depacon IV and Depakote
STARTED	15
COMPLETED	14
NOT COMPLETED	1
Lost to Follow-up	1

Baseline Characteristics

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Reporting Groups

	Description
Depacon IV and Depakote	Subjects will be treated with 2 consecutive days of IV Depacon (1000 mg/day) followed by oral Depakote ER (1000 mg/day). Subject continues oral Depakote ER until end of cluster cycle or for a maximum of 6 weeks, which ever comes first.

Baseline Measures

	Depacon IV and Depakote
Number of Participants [units: participants]	15
Age [units: participants]
<=18 years	0
Between 18 and 65 years	15
>=65 years	0
Age [units: years] Mean ± Standard Deviation	40.8 ± 10.8
Gender [units: participants]
Female	5
Male	10
Region of Enrollment [units: participants]
United States	15

Outcome Measures

1. Primary:

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 ]

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2. Secondary:

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 ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

3. Secondary:

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) ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Stephen D. Silberstein-Principal Investigator
Organization: Thomas Jefferson University/Jefferson Headache Center
phone: 215-955-9477
e-mail: Stephen.Silberstein@jefferson.edu

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