Clinical trial NCT01016834: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Keywords: migraine
treatment satisfaction
Lead sponsor: Zogenix, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Synteract, Inc.
First posted: 2009-11-20
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall Satisfaction
timeFrame: After 4 migraines or 60 days
Secondary outcomes:
measure: Treatment Preference
timeFrame: After 4 migraines or 60 days
measure: Treatment Confidence
timeFrame: After 4 migraines or 60 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Hospital, Dept. of Neurology
state: Alabama
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Newport Beach
country: United States
facility: C. Phillip O'Carroll, MD, Inc
state: California
city: Santa Monica
country: United States
facility: California Medical Clinic for Headache
state: California
city: Boulder
country: United States
facility: Alpine Clinical Research
state: Colorado
city: Pembroke Pines
country: United States
facility: University Clinical Research Inc.
state: Florida
city: St Petersburg
country: United States
facility: Comprehensive Neuroscience Inc
state: Florida
city: Atlanta
country: United States
facility: Comprehensive Neurosciences Inc
state: Georgia
city: Decatur
country: United States
facility: Neurology Specialists of Decatur
state: Georgia
city: Chicago
country: United States
facility: Diamond Headache Clinic
state: Illinois
city: Ann Arbor
country: United States
facility: Michigan Head, Pain, & Neurological Institute
state: Michigan
city: Saint Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Springfield
country: United States
facility: Clinvest/A Division of Banyan Group, Inc
state: Missouri
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Endwell
country: United States
facility: Regional Clinical Research Inc
state: New York
city: Greensboro
country: United States
facility: Headache Wellness Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic: Neurological Center for Pain
state: Ohio
city: Philadelphia
country: United States
facility: Jefferson Headache Center
state: Pennsylvania
city: Clarksville
country: United States
facility: Neurological Medicine
state: Tennessee
city: Nashville
country: United States
facility: Nashville Neuroscience Group
state: Tennessee
city: Seattle
country: United States
facility: Swedish Pain and Headache Center
state: Washington
Study officials:
affiliation: Clinvest
name: Roger K Cady, MD
role: STUDY_CHAIR
References:
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.
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.