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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 Preference

Treatment 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

Page last updated: August 23, 2015

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