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

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ClinicalTrials.gov Identifier: NCT00203242
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : July 6, 2011
Last Update Posted : July 15, 2011
Sponsor:
Collaborator:
Abbott
Information provided by:
Thomas Jefferson University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cluster Headache
Intervention Drug: Depacon IV and Depakote ER
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Depacon IV and Depakote
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 15
Completed 14
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title Depacon IV and Depakote
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
40.8  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
5
  33.3%
Male
10
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title 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.
Hide Description 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.
Time Frame baseline (day 0) through 47 days after first infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Depacon IV and Depakote
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: days
29.7  (13.8)
2.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame Compare Baseline through 47 days
Outcome Measure Data Not Reported
3.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame Baseline compared to maintenance (up to 47 days)
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Depacon IV and Depakote
Hide Arm/Group Description 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.
All-Cause Mortality
Depacon IV and Depakote
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Depacon IV and Depakote
Affected / at Risk (%)
Total   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Depacon IV and Depakote
Affected / at Risk (%)
Total   7/15 (46.67%) 
Gastrointestinal disorders   
Nausea  1/15 (6.67%) 
Metabolism and nutrition disorders   
cool sensation [1]  2/15 (13.33%) 
Increased appetite  1/15 (6.67%) 
Nervous system disorders   
Tiredness  3/15 (20.00%) 
Taste perversion  1/15 (6.67%) 
Warm sensation  1/15 (6.67%) 
Lightheadedness  1/15 (6.67%) 
[1]
Cool sensation during infusion
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Stephen D. Silberstein-Principal Investigator
Organization: Thomas Jefferson University/Jefferson Headache Center
Phone: 215-955-9477
EMail: Stephen.Silberstein@jefferson.edu
Layout table for additonal information
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
First Submitted: September 13, 2005
First Posted: September 20, 2005
Results First Submitted: June 7, 2011
Results First Posted: July 6, 2011
Last Update Posted: July 15, 2011