MigrainePhase 4NCT01016834
Evaluation of Treatment Satisfaction and Preference for Sumavel DosePro in the Treatment of Migraine
A Phase 4 study testing Sumavel DosePro and Sumatriptan in people with Migraine, run by Zogenix, Inc. at 21 sites in United States.
Trial summary
The purpose of the study is to evaluate the treatment satisfaction of subjects using Sumavel DosePro to treat their moderate to severe migraines. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Sumavel DosePro and Sumatriptan
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 21 sitesUnited States
- Study dates
- 30 Nov 2009to 30 Apr 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Michigan Head, Pain, & Neurological Institute
Ann Arbor, Michigan, 48104
Comprehensive Neurosciences Inc
Atlanta, Georgia, 30328
University of Alabama Hospital, Dept. of Neurology
Birmingham, Alabama, 35233
Alpine Clinical Research
Boulder, Colorado, 80304
Diamond Headache Clinic
Chicago, Illinois, 60614
Neurological Medicine
Clarksville, Tennessee, 37043
Cleveland Clinic: Neurological Center for Pain
Cleveland, Ohio, 33195
Neurology Specialists of Decatur
Decatur, Georgia, 30033
Regional Clinical Research Inc
Endwell, New York, 13760
Headache Wellness Center
Greensboro, North Carolina, 27405
Nashville Neuroscience Group
Nashville, Tennessee, 37203
C. Phillip O'Carroll, MD, Inc
Newport Beach, California, 92660
Meridian Clinical Research
Omaha, Nebraska, 68134
University Clinical Research Inc.
Pembroke Pines, Florida, 33024
Jefferson Headache Center
Philadelphia, Pennsylvania, 19107
Arizona Research Center
Phoenix, Arizona, 85023
California Medical Clinic for Headache
Santa Monica, California, 90404
Swedish Pain and Headache Center
Seattle, Washington, 98104
Clinvest/A Division of Banyan Group, Inc
Springfield, Missouri, 65807
Mercy Health Research
St Louis, Missouri, 63141
Comprehensive Neuroscience Inc
St. Petersburg, Florida, 33716
About this study
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
The purpose of the study is to evaluate the treatment satisfaction of subjects using Sumavel DosePro to treat their moderate to severe migraines.
Read the 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.
- Conditions
- Migraine
- Being tested
- Sumavel DosePro, Sumatriptan
- Keywords
- migraine, treatment satisfaction
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sumavel DoseProDevice
Needle free delivery system containing 0.5 mL of solution of 6 mg sumatriptan, subcutaneous administration
SumatriptanDrug
Also called Sumavel DosePro (Sumatriptan injection)
subcutaneous injection, 6 mg, per migraine attack, no more than two administrations within a 24 hr period
| Study group | Role | What they receive |
|---|---|---|
| Sumavel(R) DosePro(R) | Other | Single arm study (Sumavel DosePro) Receives: Device: Sumavel DosePro; Drug: Sumatriptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Treatment Satisfaction at the End of the Treatment
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).
Measured: At the end of the treatment (after 4 migraines or 60 days, whichever came first)
Secondary outcomes (2)
Treatment Preference
Number of participants preferring Sumavel DosePro compared to their pre-study migraine treatment (Prefer Sumavel DosePro vs. No Preference or Prefer Other Treatment).
Measured: After 4 migraines or 60 days whichever came first
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.
Measured: After 4 migraines or 60 days whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study start30 Nov 2009
- Primary completion30 Apr 2010
- Study completion30 Apr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zogenix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Synteract, Inc.
- Responsible party
- Sponsor
- Investigators
- Roger K Cady, MD, Study chair, Clinvest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016834
- Sponsor's protocol ID
- ZX001-0901
- Status last verified
- May 2026
- First submitted
- 18 Nov 2009
- Last updated
- 8 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rothrock JF, Cady RK, Aurora SK, Brandes JL, Myers JA, Fox AW, Farr SJ. Needle-free subcutaneous sumatriptan for triptan users requiring a change in migraine therapy: efficacy and impact on patient-rated functionality, satisfaction, and confidence. Curr Med Res Opin. 2011 Nov;27(11):2185-91. doi: 10.1185/03007995.2011.619177. Epub 2011 Sep 26.
PubMed 21942531Cady RK, Aurora SK, Brandes JL, Rothrock JF, Myers JA, Fox AW, Farr SJ. Satisfaction with and confidence in needle-free subcutaneous sumatriptan in patients currently treated with triptans. Headache. 2011 Sep;51(8):1202-11. doi: 10.1111/j.1526-4610.2011.01972.x. Epub 2011 Aug 3.
PubMed 21812775
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01016834
- Acronym / sponsor ID
- ZX001-0901
- Conditions
- Migraine
- Keywords
- migraine, treatment satisfaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Zogenix, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Synteract, Inc.
- Study start
- 30 Nov 2009 (actual)
- Primary completion
- 30 Apr 2010 (actual)
- Study completion
- 30 Apr 2010 (actual)
- First posted
- 20 Nov 2009 (estimated)
- Results
- Posted 29 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sumavel(R) DosePro(R) | Other | Device: Sumavel DosePro, Drug: SumatriptanSingle arm study (Sumavel DosePro) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sumavel DoseProNeedle free delivery system containing 0.5 mL of solution of 6 mg sumatriptan, subcutaneous administration | Device | Sumavel(R) DosePro(R) |
| SumatriptanAlso: Sumavel DosePro (Sumatriptan injection)subcutaneous injection, 6 mg, per migraine attack, no more than two administrations within a 24 hr period | Drug | Sumavel(R) DosePro(R) |
Primary outcome
Overall Treatment Satisfaction at the End of the Treatment
Time frame: 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).
2 secondary outcomes
Treatment Preference
Time frame: After 4 migraines or 60 days whichever came first
Treatment Confidence
Time frame: After 4 migraines or 60 days whichever came first
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21942531Rothrock JF, Cady RK, Aurora SK, Brandes JL, Myers JA, Fox AW, Farr SJ. Needle-free subcutaneous sumatriptan for triptan users requiring a change in migraine therapy: efficacy and impact on patient-rated functionality, satisfaction, and confidence. Curr Med Res Opin. 2011 Nov;27(11):2185-91. doi: 10.1185/03007995.2011.619177. Epub 2011 Sep 26.
- Derived from this study: PubMed 21812775Cady RK, Aurora SK, Brandes JL, Rothrock JF, Myers JA, Fox AW, Farr SJ. Satisfaction with and confidence in needle-free subcutaneous sumatriptan in patients currently treated with triptans. Headache. 2011 Sep;51(8):1202-11. doi: 10.1111/j.1526-4610.2011.01972.x. Epub 2011 Aug 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger K Cady, MD study chair
Clinvest
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sumavel DosePro and Sumatriptan in people with Migraine, run by Zogenix, Inc. at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Treatment Satisfaction at the End of the Treatment (time frame: At the end of the treatment (after 4 migraines or 60 days, whichever came first)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01016834, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.