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

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

The purpose of the study is to evaluate the treatment satisfaction of subjects using Sumavel DosePro to treat their moderate to severe migraines.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Device: Sumavel DosePro; Drug: Sumatriptan

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.

• Study Type: Interventional
• Enrollment (Actual): 246
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: Sumavel DosePro (Sumatriptan injection)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	After 4 migraines or 60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	After 4 migraines or 60 days
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.	After 4 migraines or 60 days

Collaborators and Investigators

• Sponsor: Zogenix, Inc.
• Collaborators: Synteract, Inc.
• Investigators: Study Chair: Roger K Cady, MD, Clinvest

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: November 18, 2009
• First Submitted That Met QC Criteria: November 19, 2009
• First Posted (Estimate): November 20, 2009

Study Record Updates

• Last Update Posted (Estimate): December 29, 2011
• Last Update Submitted That Met QC Criteria: November 28, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: migraine; treatment satisfaction
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Vasoconstrictor Agents; Sumatriptan
• Other Study ID Numbers: ZX001-0901