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

This study has been completed.
Synteract, Inc.
Information provided by (Responsible Party):
Zogenix, Inc. Identifier:
First received: November 18, 2009
Last updated: November 28, 2011
Last verified: November 2011
The purpose of the study is to evaluate the treatment satisfaction of subjects using Sumavel DosePro to treat their moderate to severe migraines.

Condition Intervention Phase
Device: Sumavel DosePro
Drug: Sumatriptan
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Zogenix, Inc.:

Primary Outcome Measures:
  • Overall Satisfaction [ Time Frame: After 4 migraines or 60 days ]
    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 [ Time Frame: After 4 migraines or 60 days ]
    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 [ Time Frame: After 4 migraines or 60 days ]
    Number of subjects who indicated they were confident or very confident in treating repeated migraine attacks with Sumavel DosePro at end of treatment.

Enrollment: 246
Study Start Date: November 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sumavel(R) DosePro(R)
Single arm study (Sumavel DosePro)
Device: Sumavel DosePro
Needle free delivery system containing 0.5 mL of solution of 6 mg sumatriptan, subcutaneous administration
Drug: Sumatriptan
subcutaneous injection, 6 mg, per migraine attack, no more than two administrations within a 24 hr period
Other Name: Sumavel DosePro (Sumatriptan injection)

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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01016834

  Hide Study Locations
United States, Alabama
University of Alabama Hospital, Dept. of Neurology
Birmingham, Alabama, United States, 35233
United States, Arizona
Arizona Research Center
Phoenix, Arizona, United States, 85023
United States, California
C. Phillip O'Carroll, MD, Inc
Newport Beach, California, United States, 92660
California Medical Clinic for Headache
Santa Monica, California, United States, 90404
United States, Colorado
Alpine Clinical Research
Boulder, Colorado, United States, 80304
United States, Florida
University Clinical Research Inc.
Pembroke Pines, Florida, United States, 33024
Comprehensive Neuroscience Inc
St Petersburg, Florida, United States, 33716
United States, Georgia
Comprehensive Neurosciences Inc
Atlanta, Georgia, United States, 30328
Neurology Specialists of Decatur
Decatur, Georgia, United States, 30033
United States, Illinois
Diamond Headache Clinic
Chicago, Illinois, United States, 60614
United States, Michigan
Michigan Head, Pain, & Neurological Institute
Ann Arbor, Michigan, United States, 48104
United States, Missouri
Mercy Health Research
Saint Louis, Missouri, United States, 63141
Clinvest/A Division of Banyan Group, Inc
Springfield, Missouri, United States, 65807
United States, Nebraska
Meridian Clinical Research
Omaha, Nebraska, United States, 68134
United States, New York
Regional Clinical Research Inc
Endwell, New York, United States, 13760
United States, North Carolina
Headache Wellness Center
Greensboro, North Carolina, United States, 27405
United States, Ohio
Cleveland Clinic: Neurological Center for Pain
Cleveland, Ohio, United States, 33195
United States, Pennsylvania
Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Neurological Medicine
Clarksville, Tennessee, United States, 37043
Nashville Neuroscience Group
Nashville, Tennessee, United States, 37203
United States, Washington
Swedish Pain and Headache Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Zogenix, Inc.
Synteract, Inc.
Study Chair: Roger K Cady, MD Clinvest
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Zogenix, Inc. 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

Keywords provided by Zogenix, Inc.:
treatment satisfaction

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on March 30, 2017