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| Name | Class |
|---|---|
| Synteract, Inc. | INDUSTRY |
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The purpose of the study is to evaluate the treatment satisfaction of subjects using Sumavel DosePro to treat their moderate to severe migraines.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sumavel(R) DosePro(R) | Other | Single arm study (Sumavel DosePro) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sumavel DosePro | Device | Needle free delivery system containing 0.5 mL of solution of 6 mg sumatriptan, subcutaneous administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At the end of the treatment (after 4 migraines or 60 days, whichever came first) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | After 4 migraines or 60 days whichever came first |
| Treatment Confidence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger K Cady, MD | Clinvest | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Hospital, Dept. of Neurology | Birmingham | Alabama | 35233 | United States | ||
| Arizona Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21942531 | Derived | 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. | |
| 21812775 |
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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.
Recruitment period occured from November, 2009 to February, 2010 at 22 US medical clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Sumatriptan | Drug | subcutaneous injection, 6 mg, per migraine attack, no more than two administrations within a 24 hr period |
|
|
Number of subjects who indicated they were confident or very confident in treating repeated migraine attacks with Sumavel DosePro at end of treatment. |
| After 4 migraines or 60 days whichever came first |
| Phoenix |
| Arizona |
| 85023 |
| United States |
| C. Phillip O'Carroll, MD, Inc | Newport Beach | California | 92660 | United States |
| California Medical Clinic for Headache | Santa Monica | California | 90404 | United States |
| Alpine Clinical Research | Boulder | Colorado | 80304 | United States |
| University Clinical Research Inc. | Pembroke Pines | Florida | 33024 | United States |
| Comprehensive Neuroscience Inc | St. Petersburg | Florida | 33716 | United States |
| Comprehensive Neurosciences Inc | Atlanta | Georgia | 30328 | United States |
| Neurology Specialists of Decatur | Decatur | Georgia | 30033 | United States |
| Diamond Headache Clinic | Chicago | Illinois | 60614 | United States |
| Michigan Head, Pain, & Neurological Institute | Ann Arbor | Michigan | 48104 | United States |
| Clinvest/A Division of Banyan Group, Inc | Springfield | Missouri | 65807 | United States |
| Mercy Health Research | St Louis | Missouri | 63141 | United States |
| Meridian Clinical Research | Omaha | Nebraska | 68134 | United States |
| Regional Clinical Research Inc | Endwell | New York | 13760 | United States |
| Headache Wellness Center | Greensboro | North Carolina | 27405 | United States |
| Cleveland Clinic: Neurological Center for Pain | Cleveland | Ohio | 33195 | United States |
| Jefferson Headache Center | Philadelphia | Pennsylvania | 19107 | United States |
| Neurological Medicine | Clarksville | Tennessee | 37043 | United States |
| Nashville Neuroscience Group | Nashville | Tennessee | 37203 | United States |
| Swedish Pain and Headache Center | Seattle | Washington | 98104 | United States |
| Cady 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. |
| Safety Population |
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| Per-Protocol Population |
|
| COMPLETED |
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| NOT COMPLETED |
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Baseline Characteristics refer to the Safety Population including all participants who received at least one dose of Sumavel DosePro.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | At the end of the treatment (after 4 migraines or 60 days, whichever came first) |
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| Secondary | 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). | 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. | Posted | Number | participants | After 4 migraines or 60 days whichever came first |
|
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| 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. | 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. | Posted | Number | participants | After 4 migraines or 60 days whichever came first |
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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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 242 | 0 | 242 | 136 | 242 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Administrative site conditions | General disorders | MedDRA (10.0) | Non-systematic Assessment | Inclusive of all single reports of injection site hemorrhage,hematoma, pain, swelling, and erythema |
|
| Dizzyness | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Paresthesia | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judith Myers, Senior Director Clinical Operations | Zogenix | 510-550-8300 | jmyers@zogenix.com |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D018170 | Sumatriptan |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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