Evaluation of Treatment Satisfaction and Preference for Sumavel DosePro in the Treatment of Migraine
The purpose of the study is to evaluate the treatment satisfaction of subjects using Sumavel DosePro to treat their moderate to severe migraines.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Overall Satisfaction [ Time Frame: After 4 migraines or 60 days ] [ Designated as safety issue: No ]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)
- Treatment Preference [ Time Frame: After 4 migraines or 60 days ] [ Designated as safety issue: No ]Number of subjects preferring Sumavel DosePro compared to their pre-study migraine treatment (Prefer Sumavel DosePro vs. No Preference or Prefer Other Treatment).
- Treatment Confidence [ Time Frame: After 4 migraines or 60 days ] [ Designated as safety issue: No ]Number of subjects who indicated they were confident or very confident in treating repeated migraine attacks with Sumavel DosePro at end of treatment.
|Study Start Date:||November 2009|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Single arm study (Sumavel DosePro)
Device: Sumavel DosePro
Needle free delivery system containing 0.5 mL of solution of 6 mg sumatriptan, subcutaneous administrationDrug: Sumatriptan
subcutaneous injection, 6 mg, per migraine attack, no more than two administrations within a 24 hr period
Other Name: Sumavel DosePro (Sumatriptan injection)
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.
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|Study Chair:||Roger K Cady, MD||Clinvest/A Division of Banyan Group Inc|