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

NCT ID: NCT01016834

Last Updated: 2011-12-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

246 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-04-30

Brief Summary

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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

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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.

Conditions

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Migraine

Keywords

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migraine treatment satisfaction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sumavel(R) DosePro(R)

Single arm study (Sumavel DosePro)

Group Type OTHER

Sumavel DosePro

Intervention Type DEVICE

Needle free delivery system containing 0.5 mL of solution of 6 mg sumatriptan, subcutaneous administration

Sumatriptan

Intervention Type DRUG

subcutaneous injection, 6 mg, per migraine attack, no more than two administrations within a 24 hr period

Interventions

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Sumavel DosePro

Needle free delivery system containing 0.5 mL of solution of 6 mg sumatriptan, subcutaneous administration

Intervention Type DEVICE

Sumatriptan

subcutaneous injection, 6 mg, per migraine attack, no more than two administrations within a 24 hr period

Intervention Type DRUG

Other Intervention Names

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Sumavel DosePro (Sumatriptan injection)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Synteract, Inc.

INDUSTRY

Sponsor Role collaborator

Zogenix, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roger K Cady, MD

Role: STUDY_CHAIR

Clinvest

Locations

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University of Alabama Hospital, Dept. of Neurology

Birmingham, Alabama, United States

Site Status

Arizona Research Center

Phoenix, Arizona, United States

Site Status

C. Phillip O'Carroll, MD, Inc

Newport Beach, California, United States

Site Status

California Medical Clinic for Headache

Santa Monica, California, United States

Site Status

Alpine Clinical Research

Boulder, Colorado, United States

Site Status

University Clinical Research Inc.

Pembroke Pines, Florida, United States

Site Status

Comprehensive Neuroscience Inc

St. Petersburg, Florida, United States

Site Status

Comprehensive Neurosciences Inc

Atlanta, Georgia, United States

Site Status

Neurology Specialists of Decatur

Decatur, Georgia, United States

Site Status

Diamond Headache Clinic

Chicago, Illinois, United States

Site Status

Michigan Head, Pain, & Neurological Institute

Ann Arbor, Michigan, United States

Site Status

Clinvest/A Division of Banyan Group, Inc

Springfield, Missouri, United States

Site Status

Mercy Health Research

St Louis, Missouri, United States

Site Status

Meridian Clinical Research

Omaha, Nebraska, United States

Site Status

Regional Clinical Research Inc

Endwell, New York, United States

Site Status

Headache Wellness Center

Greensboro, North Carolina, United States

Site Status

Cleveland Clinic: Neurological Center for Pain

Cleveland, Ohio, United States

Site Status

Jefferson Headache Center

Philadelphia, Pennsylvania, United States

Site Status

Neurological Medicine

Clarksville, Tennessee, United States

Site Status

Nashville Neuroscience Group

Nashville, Tennessee, United States

Site Status

Swedish Pain and Headache Center

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 21942531 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21812775 (View on PubMed)

Other Identifiers

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ZX001-0901

Identifier Type: -

Identifier Source: org_study_id