Trial Outcomes & Findings for Evaluation of Treatment Satisfaction and Preference for Sumavel DosePro in the Treatment of Migraine (NCT NCT01016834)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

246 participants

Primary outcome timeframe

After 4 migraines or 60 days

Results posted on

2011-12-29

Participant Flow

Recruitment period occured from November, 2009 to February, 2010 at 22 US medical clinics

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	242
Overall Study COMPLETED	220
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sumavel DosePro n=242 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	242 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	196 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants
Region of Enrollment United States	242 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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)

Outcome measures

Outcome measures
Measure	Sumavel DosePro n=211 Participants 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.
Overall Satisfaction	73.7 Scale of 0-100; 100= very satisfied Standard Deviation 29.08

SECONDARY outcome

Timeframe: After 4 migraines or 60 days

Number of subjects preferring Sumavel DosePro compared to their pre-study migraine treatment (Prefer Sumavel DosePro vs. No Preference or Prefer Other Treatment).

Outcome measures

Outcome measures
Measure	Sumavel DosePro n=211 Participants 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.
Treatment Preference	74 participants Interval 29.6 to 40.8

SECONDARY outcome

Timeframe: After 4 migraines or 60 days

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

Outcome measures
Measure	Sumavel DosePro n=211 Participants 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.
Treatment Confidence	136 participants

Adverse Events

Sumavel DosePro

Serious events: 0 serious events

Other events: 136 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sumavel DosePro n=242 participants at risk 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.
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.
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.
Musculoskeletal and connective tissue disorders Muscle tightness	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.

Additional Information

Judith Myers, Senior Director Clinical Operations

Zogenix

Phone: 510-550-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60