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

Primary Purpose

Migraine

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sumavel DosePro
Sumatriptan
Sponsored by
Zogenix, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring migraine, treatment satisfaction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • History of 2 to 6 migraine headaches per month
  • Migraines should have been present for at least 1 year with age at onset of migraine less than 50 years
  • History of 24 hours of freedom between migraine attacks
  • Current users of triptan medications
  • Able to distinguish interval or other non-migrainous headaches from typical migraine
  • General good health

Exclusion Criteria:

  • History or symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes
  • Significant underlying cardiovascular diseases including uncontrolled hypertension
  • Hemiplegic or basilar migraine
  • History or diagnosis of severe hepatic or renal impairment
  • History of epilepsy or seizure or other serious neurologic condition
  • History of allergy, anaphylaxis, or hypersensitivity to sumatriptan or any of its components or similar drugs including sulphonamides
  • History of scleroderma (systemic sclerosis)
  • Pregnant or breastfeeding
  • Use of contraindicated prescription medications, monoamine oxidase inhibitors (MAO-A), selective serotonin reuptake inhibitors, or lithium agents

Sites / Locations

  • University of Alabama Hospital, Dept. of Neurology
  • Arizona Research Center
  • C. Phillip O'Carroll, MD, Inc
  • California Medical Clinic for Headache
  • Alpine Clinical Research
  • University Clinical Research Inc.
  • Comprehensive Neuroscience Inc
  • Comprehensive Neurosciences Inc
  • Neurology Specialists of Decatur
  • Diamond Headache Clinic
  • Michigan Head, Pain, & Neurological Institute
  • Mercy Health Research
  • Clinvest/A Division of Banyan Group, Inc
  • Meridian Clinical Research
  • Regional Clinical Research Inc
  • Headache Wellness Center
  • Cleveland Clinic: Neurological Center for Pain
  • Jefferson Headache Center
  • Neurological Medicine
  • Nashville Neuroscience Group
  • Swedish Pain and Headache Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Sumavel(R) DosePro(R)

Arm Description

Single arm study (Sumavel DosePro)

Outcomes

Primary Outcome Measures

Overall Satisfaction
Change from baseline in overall subject satisfaction with migraine treatments. Patient Perception of Migraine Questionnaire-Revised, question 3c "Overall satisfaction" was the measure. Baseline measured subjects satisfaction with past migraine treatments. End of study measured subject's satisfaction with migraine treatment by Sumavel DosePro. PPMQ-R scale (1-7 scale; 1=very satisfied)is transformed to a 0-100 scale (100=very satisfied)

Secondary Outcome Measures

Treatment Preference
Number of subjects preferring Sumavel DosePro compared to their pre-study migraine treatment (Prefer Sumavel DosePro vs. No Preference or Prefer Other Treatment).
Treatment Confidence
Number of subjects who indicated they were confident or very confident in treating repeated migraine attacks with Sumavel DosePro at end of treatment.

Full Information

First Posted
November 18, 2009
Last Updated
November 28, 2011
Sponsor
Zogenix, Inc.
Collaborators
Synteract, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01016834
Brief Title
Evaluation of Treatment Satisfaction and Preference for Sumavel DosePro in the Treatment of Migraine
Official Title
A Multicenter, Open-label Evaluation of Treatment Satisfaction, Tolerability, Safety and Preference for Sumavel DosePro for Treatment of Migraine in Subjects Currently Treated With Triptans
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zogenix, Inc.
Collaborators
Synteract, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to evaluate the treatment satisfaction of subjects using Sumavel DosePro to treat their moderate to severe migraines.
Detailed Description
Single arm, open-label, multicenter study to evaluate the treatment satisfaction, treatment confidence, and subject preference for Sumavel DosePro in adult subjects diagnosed with migraines and currently treated with triptans. Subjects will treat up to 4 migraines over a 60 day period and complete migraine diaries and questionnaires.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
migraine, treatment satisfaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
246 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sumavel(R) DosePro(R)
Arm Type
Other
Arm Description
Single arm study (Sumavel DosePro)
Intervention Type
Device
Intervention Name(s)
Sumavel DosePro
Intervention Description
Needle free delivery system containing 0.5 mL of solution of 6 mg sumatriptan, subcutaneous administration
Intervention Type
Drug
Intervention Name(s)
Sumatriptan
Other Intervention Name(s)
Sumavel DosePro (Sumatriptan injection)
Intervention Description
subcutaneous injection, 6 mg, per migraine attack, no more than two administrations within a 24 hr period
Primary Outcome Measure Information:
Title
Overall Satisfaction
Description
Change from baseline in overall subject satisfaction with migraine treatments. Patient Perception of Migraine Questionnaire-Revised, question 3c "Overall satisfaction" was the measure. Baseline measured subjects satisfaction with past migraine treatments. End of study measured subject's satisfaction with migraine treatment by Sumavel DosePro. PPMQ-R scale (1-7 scale; 1=very satisfied)is transformed to a 0-100 scale (100=very satisfied)
Time Frame
After 4 migraines or 60 days
Secondary Outcome Measure Information:
Title
Treatment Preference
Description
Number of subjects preferring Sumavel DosePro compared to their pre-study migraine treatment (Prefer Sumavel DosePro vs. No Preference or Prefer Other Treatment).
Time Frame
After 4 migraines or 60 days
Title
Treatment Confidence
Description
Number of subjects who indicated they were confident or very confident in treating repeated migraine attacks with Sumavel DosePro at end of treatment.
Time Frame
After 4 migraines or 60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of 2 to 6 migraine headaches per month Migraines should have been present for at least 1 year with age at onset of migraine less than 50 years History of 24 hours of freedom between migraine attacks Current users of triptan medications Able to distinguish interval or other non-migrainous headaches from typical migraine General good health Exclusion Criteria: History or symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes Significant underlying cardiovascular diseases including uncontrolled hypertension Hemiplegic or basilar migraine History or diagnosis of severe hepatic or renal impairment History of epilepsy or seizure or other serious neurologic condition History of allergy, anaphylaxis, or hypersensitivity to sumatriptan or any of its components or similar drugs including sulphonamides History of scleroderma (systemic sclerosis) Pregnant or breastfeeding Use of contraindicated prescription medications, monoamine oxidase inhibitors (MAO-A), selective serotonin reuptake inhibitors, or lithium agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger K Cady, MD
Organizational Affiliation
Clinvest
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama Hospital, Dept. of Neurology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
C. Phillip O'Carroll, MD, Inc
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
California Medical Clinic for Headache
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Alpine Clinical Research
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
University Clinical Research Inc.
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Comprehensive Neuroscience Inc
City
St Petersburg
State/Province
Florida
ZIP/Postal Code
33716
Country
United States
Facility Name
Comprehensive Neurosciences Inc
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Neurology Specialists of Decatur
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Diamond Headache Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Michigan Head, Pain, & Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Mercy Health Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Clinvest/A Division of Banyan Group, Inc
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Meridian Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Regional Clinical Research Inc
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Headache Wellness Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Facility Name
Cleveland Clinic: Neurological Center for Pain
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
33195
Country
United States
Facility Name
Jefferson Headache Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Neurological Medicine
City
Clarksville
State/Province
Tennessee
ZIP/Postal Code
37043
Country
United States
Facility Name
Nashville Neuroscience Group
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Swedish Pain and Headache Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21942531
Citation
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.
Results Reference
derived
PubMed Identifier
21812775
Citation
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.
Results Reference
derived

Learn more about this trial

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

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