Trial Outcomes & Findings for Evaluation of Treatment Satisfaction and Preference for Sumavel DosePro in the Treatment of Migraine (NCT NCT01016834)
NCT ID: NCT01016834
Last Updated: 2026-06-08
Results Overview
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).
COMPLETED
PHASE4
246 participants
At the end of the treatment (after 4 migraines or 60 days, whichever came first)
2026-06-08
Participant Flow
Recruitment period occured from November, 2009 to February, 2010 at 22 US medical clinics.
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.
Participant milestones
| Measure |
Sumavel DosePro
Participants used the Sumavel DosePro, a needle free delivery system containing 0.5 milliliter (mL) of solution of 6 milligrams (mg) sumatriptan. Participants took 6 mg sumatriptan as subcutaneous injection, per migraine attack. Not more, than two adminstrations were allowed within a 24 hours period.
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|---|---|
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Overall Study
STARTED
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246
|
|
Overall Study
Safety Population
|
242
|
|
Overall Study
Per-Protocol Population
|
212
|
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Overall Study
COMPLETED
|
220
|
|
Overall Study
NOT COMPLETED
|
26
|
Reasons for withdrawal
| Measure |
Sumavel DosePro
Participants used the Sumavel DosePro, a needle free delivery system containing 0.5 milliliter (mL) of solution of 6 milligrams (mg) sumatriptan. Participants took 6 mg sumatriptan as subcutaneous injection, per migraine attack. Not more, than two adminstrations were allowed within a 24 hours period.
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|---|---|
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Overall Study
Protocol Violation
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Non-Compliance
|
2
|
|
Overall Study
Subject decision
|
13
|
|
Overall Study
Did Not Treat Due To Work Situation
|
1
|
Baseline Characteristics
Evaluation of Treatment Satisfaction and Preference for Sumavel DosePro in the Treatment of Migraine
Baseline characteristics by cohort
| Measure |
Sumavel DosePro
n=242 Participants
Participants used the Sumavel DosePro, a needle free delivery system containing 0.5 milliliter (mL) of solution of 6 milligrams (mg) sumatriptan. Participants took 6 mg sumatriptan as subcutaneous injection, per migraine attack. Not more, than two adminstrations were allowed within a 24 hours period.
|
|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
242 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
196 Participants
n=9 Participants
|
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Sex: Female, Male
Male
|
46 Participants
n=9 Participants
|
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Region of Enrollment
United States
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242 Participants
n=9 Participants
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PRIMARY outcome
Timeframe: At the end of the treatment (after 4 migraines or 60 days, whichever came first)Population: The Per-protocol (PP) population included all participants who treated at least one (and up to four) migraine episode(s) with Sumavel DosePro and complied with all other study procedures. Here, number of participants analyzed (211) included those participants who were evaluable for the assessment.
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).
Outcome measures
| Measure |
Sumavel DosePro
n=211 Participants
Participants used the Sumavel DosePro, a needle free delivery system containing 0.5 milliliter (mL) of solution of 6 milligrams (mg) sumatriptan. Participants took 6 mg sumatriptan as subcutaneous injection, per migraine attack. Not more, than two adminstrations were allowed within a 24 hours period.
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|---|---|
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Overall Treatment Satisfaction at the End of the Treatment
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73.7 units on a scale
Standard Deviation 29.08
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SECONDARY outcome
Timeframe: After 4 migraines or 60 days whichever came firstPopulation: The Per-protocol (PP) population included all participants who treated at least one (and up to four) migraine episode(s) with Sumavel DosePro and complied with all other study procedures. Here, number of participants analyzed (211) included those participants who were evaluable for the assessment.
Number of participants preferring Sumavel DosePro compared to their pre-study migraine treatment (Prefer Sumavel DosePro vs. No Preference or Prefer Other Treatment).
Outcome measures
| Measure |
Sumavel DosePro
n=211 Participants
Participants used the Sumavel DosePro, a needle free delivery system containing 0.5 milliliter (mL) of solution of 6 milligrams (mg) sumatriptan. Participants took 6 mg sumatriptan as subcutaneous injection, per migraine attack. Not more, than two adminstrations were allowed within a 24 hours period.
|
|---|---|
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Treatment Preference
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74 participants
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SECONDARY outcome
Timeframe: After 4 migraines or 60 days whichever came firstPopulation: The Per-protocol (PP) population included all participants who treated at least one (and up to four) migraine episode(s) with Sumavel DosePro and complied with all other study procedures. Here, number of participants analyzed (211) included those participants who were evaluable for the assessment.
Number of subjects who indicated they were confident or very confident in treating repeated migraine attacks with Sumavel DosePro at end of treatment.
Outcome measures
| Measure |
Sumavel DosePro
n=211 Participants
Participants used the Sumavel DosePro, a needle free delivery system containing 0.5 milliliter (mL) of solution of 6 milligrams (mg) sumatriptan. Participants took 6 mg sumatriptan as subcutaneous injection, per migraine attack. Not more, than two adminstrations were allowed within a 24 hours period.
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|---|---|
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Treatment Confidence
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137 participants
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Adverse Events
Sumavel DosePro
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sumavel DosePro
n=242 participants at risk
Participants used the Sumavel DosePro, a needle free delivery system containing 0.5 milliliter (mL) of solution of 6 milligrams (mg) sumatriptan. Participants took 6 mg sumatriptan as subcutaneous injection, per migraine attack. Not more, than two adminstrations were allowed within a 24 hours period.
|
|---|---|
|
General disorders
Administrative site conditions
|
40.9%
99/242 • 60 days
Subjects were asked to report SAEs from first dose of Sumavel DosePro up to 3-5 days post 4th migraine attack or 60 days, which ever occurred earliest.
|
|
Nervous system disorders
Dizzyness
|
7.0%
17/242 • 60 days
Subjects were asked to report SAEs from first dose of Sumavel DosePro up to 3-5 days post 4th migraine attack or 60 days, which ever occurred earliest.
|
|
Nervous system disorders
Paresthesia
|
5.8%
14/242 • 60 days
Subjects were asked to report SAEs from first dose of Sumavel DosePro up to 3-5 days post 4th migraine attack or 60 days, which ever occurred earliest.
|
|
Nervous system disorders
Somnolence
|
5.4%
13/242 • 60 days
Subjects were asked to report SAEs from first dose of Sumavel DosePro up to 3-5 days post 4th migraine attack or 60 days, which ever occurred earliest.
|
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Gastrointestinal disorders
Nausea
|
7.4%
18/242 • 60 days
Subjects were asked to report SAEs from first dose of Sumavel DosePro up to 3-5 days post 4th migraine attack or 60 days, which ever occurred earliest.
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
12/242 • 60 days
Subjects were asked to report SAEs from first dose of Sumavel DosePro up to 3-5 days post 4th migraine attack or 60 days, which ever occurred earliest.
|
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Musculoskeletal and connective tissue disorders
Muscle tightness
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5.8%
14/242 • 60 days
Subjects were asked to report SAEs from first dose of Sumavel DosePro up to 3-5 days post 4th migraine attack or 60 days, which ever occurred earliest.
|
|
Vascular disorders
Flushing
|
5.8%
14/242 • 60 days
Subjects were asked to report SAEs from first dose of Sumavel DosePro up to 3-5 days post 4th migraine attack or 60 days, which ever occurred earliest.
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Additional Information
Judith Myers, Senior Director Clinical Operations
Zogenix
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60