An Open Label Study Using Consecutive Intravenous Depacon With Oral Depakote ER for the Treatment of Cluster Headaches.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00203242|
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : July 6, 2011
Last Update Posted : July 15, 2011
|Condition or disease||Intervention/treatment||Phase|
|Cluster Headache||Drug: Depacon IV and Depakote ER||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||July 2003|
|Actual Primary Completion Date :||September 2006|
|Actual Study Completion Date :||December 2006|
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
- 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 ]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.
- 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 ]
- 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00203242
|United States, Pennsylvania|
|Jefferson Headache Center|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Stephen D Silberstein, MD||Thomas Jefferson University, Jefferson Headache Center|