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Evaluation of Treatment Satisfaction and Preference for Sumavel DosePro in the Treatment of Migraine

This study has been completed.
Sponsor:
Collaborator:
Synteract, Inc.
Information provided by (Responsible Party):
Zogenix, Inc.
ClinicalTrials.gov Identifier:
NCT01016834
First received: November 18, 2009
Last updated: November 28, 2011
Last verified: November 2011
History of Changes
Results First Received: November 28, 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: Migraine
Interventions: Device: Sumavel DosePro
Drug: Sumatriptan

  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
Recruitment period occured from November, 2009 to February, 2010 at 22 US medical clinics

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
Sumavel DosePro The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.

Participant Flow:   Overall Study
    Sumavel DosePro  
STARTED     242  
COMPLETED     220  
NOT COMPLETED     22  



  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
Sumavel DosePro The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.

Baseline Measures
    Sumavel DosePro  
Number of Participants  
[units: participants]
 		  242  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     242  
>=65 years     0  
Gender  
[units: participants]
 		 
Female     196  
Male     46  
Region of Enrollment  
[units: participants]
 		 
United States     242  



  Outcome Measures
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1.  Primary:   Overall Satisfaction   [ Time Frame: After 4 migraines or 60 days ]
  Show Outcome Measure 1

2.  Secondary:   Treatment Preference   [ Time Frame: After 4 migraines or 60 days ]
  Show Outcome Measure 2

3.  Secondary:   Treatment Confidence   [ Time Frame: After 4 migraines or 60 days ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Judith Myers, Senior Director Clinical Operations
Organization: Zogenix
phone: 510-550-8300
e-mail: jmyers@zogenix.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Zogenix, Inc.
ClinicalTrials.gov Identifier: NCT01016834     History of Changes
Other Study ID Numbers: ZX001-0901
Study First Received: November 18, 2009
Results First Received: November 28, 2011
Last Updated: November 28, 2011
Health Authority: United States: Food and Drug Administration