Migraine
Conditions
Keywords
migraine, treatment satisfaction
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.
Interventions
DEVICESumavel DosePro
Needle free delivery system containing 0.5 mL of solution of 6 mg sumatriptan, subcutaneous administration
DRUGSumatriptan
subcutaneous injection, 6 mg, per migraine attack, no more than two administrations within a 24 hr period
Sponsors
Zogenix, Inc.
Synteract, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Treatment Satisfaction at the End of the Treatment | At the end of the treatment (after 4 migraines or 60 days, whichever came first) | Overall participant satisfaction with migraine treatment Sumavel DosePro was measured using the Patient Perception of Migraine Questionnaire-Revised (PPMQ-R), question 3c "Overall satisfaction". The PPMQ-R scores (scale ranges from 1-7 with 1=very satisfied) were transformed to a 0-100 scale with higher scores indicating a higher level of treatment satisfaction (100=very satisfied). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Preference | After 4 migraines or 60 days whichever came first | Number of participants preferring Sumavel DosePro compared to their pre-study migraine treatment (Prefer Sumavel DosePro vs. No Preference or Prefer Other Treatment). |
| Treatment Confidence | After 4 migraines or 60 days whichever came first | Number of subjects who indicated they were confident or very confident in treating repeated migraine attacks with Sumavel DosePro at end of treatment. |
Countries
United States
Contacts
STUDY_CHAIRRoger K Cady, MD
Clinvest
Participant flow
Recruitment details
Recruitment period occured from November, 2009 to February, 2010 at 22 US medical clinics.
Pre-assignment details
The Participant Flow refers to all participants enrolled in the study. Four participants enrolled in the study received no treatment with Sumavel DosePro and were therefore excluded from the Safety Population.
Participants by arm
| Arm | Count |
|---|---|
| Sumavel DosePro The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject's self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period. | 242 |
| Total | 242 |
Baseline characteristics
| Characteristic | Sumavel DosePro |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 242 Participants |
| Region of Enrollment United States | 242 Participants |
| Sex: Female, Male Female | 196 Participants |
| Sex: Female, Male Male | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 242 |
| other Total, other adverse events | 136 / 242 |
| serious Total, serious adverse events | 0 / 242 |
Outcome results
Primary
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)
Time frame: After 4 migraines or 60 days
Population: The Per-protocol (PP) population included all subjects who treated at least one (and up to four) migraine episode(s) with Sumavel DosePro and complied with all other study procedures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sumavel DosePro | Overall Satisfaction | 73.7 Scale of 0-100; 100= very satisfied | Standard Deviation 29.08 |
Comparison: For the primary analyses and other PPMQ-R variables, the mean of the differences between each subject's rating of overall treatment satisfaction at the end of study based on the subject's experience using Sumavel DosePro and the rating at baseline based on the subject's pre-study triptan treatment were compared using a two-sided paired t-test at the 5% level of significancep-value: 0.0007t-test, 2 sided
Secondary
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.
Time frame: After 4 migraines or 60 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sumavel DosePro | Treatment Confidence | 136 participants |
Secondary
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).
Time frame: After 4 migraines or 60 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sumavel DosePro | Treatment Preference | 74 participants |