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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00203242
First received: September 13, 2005
Last updated: July 13, 2011
Last verified: July 2011
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 ]

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 reported.   Anticipated Reporting 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 reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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