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

Study Overview
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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.

Official Title
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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

Conditions
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Migraine

Intervention / Treatment
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* Device: Sumavel DosePro
* Drug: Sumatriptan


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sumavel(R) DosePro(R)<br>Single arm study (Sumavel DosePro) | Device: Sumavel DosePro<br>* Needle free delivery system containing 0.5 mL of solution of 6 mg sumatriptan, subcutaneous administration<br>Drug: Sumatriptan<br>* subcutaneous injection, 6 mg, per migraine attack, no more than two administrations within a 24 hr period<br>* Other names: Sumavel DosePro (Sumatriptan injection);|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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migraine, treatment satisfaction