Evaluation of Treatment Satisfaction and Preference for Sumavel DosePro in the Treatment of Migraine
Information source: Zogenix, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine
Intervention: Sumavel DosePro (Device); Sumatriptan (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Zogenix, Inc. Official(s) and/or principal investigator(s): Roger K Cady, MD, Study Chair, Affiliation: Clinvest, A Division of Banyan Group Inc.
Summary
The purpose of the study is to evaluate the treatment satisfaction of subjects using Sumavel
DosePro to treat their moderate to severe migraines.
Clinical Details
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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Overall Satisfaction
Secondary outcome: Treatment PreferenceTreatment Confidence
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
University of Alabama Hospital, Dept. of Neurology, Birmingham, Alabama 35233, United States
Arizona Research Center, Phoenix, Arizona 85023, United States
C. Phillip O'Carroll, MD, Inc, Newport Beach, California 92660, United States
California Medical Clinic for Headache, Santa Monica, California 90404, United States
Alpine Clinical Research, Boulder, Colorado 80304, United States
University Clinical Research Inc., Pembroke Pines, Florida 33024, United States
Comprehensive Neuroscience Inc, St Petersburg, Florida 33716, United States
Comprehensive Neurosciences Inc, Atlanta, Georgia 30328, United States
Neurology Specialists of Decatur, Decatur, Georgia 30033, United States
Diamond Headache Clinic, Chicago, Illinois 60614, United States
Michigan Head, Pain, & Neurological Institute, Ann Arbor, Michigan 48104, United States
Mercy Health Research, Saint Louis, Missouri 63141, United States
Clinvest/A Division of Banyan Group, Inc, Springfield, Missouri 65807, United States
Meridian Clinical Research, Omaha, Nebraska 68134, United States
Regional Clinical Research Inc, Endwell, New York 13760, United States
Headache Wellness Center, Greensboro, North Carolina 27405, United States
Cleveland Clinic: Neurological Center for Pain, Cleveland, Ohio 33195, United States
Jefferson Headache Center, Philadelphia, Pennsylvania 19107, United States
Neurological Medicine, Clarksville, Tennessee 37043, United States
Nashville Neuroscience Group, Nashville, Tennessee 37203, United States
Swedish Pain and Headache Center, Seattle, Washington 98104, United States
Additional Information
Starting date: November 2009
Last updated: November 28, 2011
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