Phase 4
Completed N=242
Evaluation of Treatment Satisfaction and Preference for Sumavel DosePro in the Treatment of Migraine
Source: ClinicalTrials.gov NCT01016834 ↗Enrolled (actual)
242
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcomePrimary: Overall Satisfaction — 73.7 Scale of 0-100; 100= very satisfied — p=0.0007
Summary
The purpose of the study is to evaluate the treatment satisfaction of subjects using Sumavel DosePro to treat their moderate to severe migraines.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Satisfaction |
73.7 | 0.0007 sig |
| SECONDARY Treatment Preference |
74 | — |
| SECONDARY Treatment Confidence |
136 | — |
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
Data sourced from ClinicalTrials.gov (NCT01016834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.