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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01016834

First Posted: November 20, 2009

Last Update Posted: December 29, 2011

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.

Collaborator:

Synteract, Inc.

Information provided by (Responsible Party):

Zogenix, Inc.

Results First Submitted: November 28, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (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.
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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.

Baseline Measures

	Sumavel DosePro
Overall Participants Analyzed [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 ]

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2. Secondary:

Treatment Preference [ Time Frame: After 4 migraines or 60 days ]

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3. Secondary:

Treatment Confidence [ Time Frame: After 4 migraines or 60 days ]

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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:

	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.
	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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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):

Rothrock JF, Cady RK, Aurora SK, Brandes JL, Myers JA, Fox AW, Farr SJ. Needle-free subcutaneous sumatriptan for triptan users requiring a change in migraine therapy: efficacy and impact on patient-rated functionality, satisfaction, and confidence. Curr Med Res Opin. 2011 Nov;27(11):2185-91. doi: 10.1185/03007995.2011.619177. Epub 2011 Sep 26.

Cady RK, Aurora SK, Brandes JL, Rothrock JF, Myers JA, Fox AW, Farr SJ. Satisfaction with and confidence in needle-free subcutaneous sumatriptan in patients currently treated with triptans. Headache. 2011 Sep;51(8):1202-11. doi: 10.1111/j.1526-4610.2011.01972.x. Epub 2011 Aug 3.

Responsible Party:	Zogenix, Inc.
ClinicalTrials.gov Identifier:	NCT01016834 History of Changes
Other Study ID Numbers:	ZX001-0901
First Submitted:	November 18, 2009
First Posted:	November 20, 2009
Results First Submitted:	November 28, 2011
Results First Posted:	December 29, 2011
Last Update Posted:	December 29, 2011

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