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The primary objective is to evaluate the safety of long-term treatment with NP101 as assessed by:
The secondary objective is to evaluate the long term efficacy of NP101 as assessed by:
This study will use an open-label design to assess the long term safety of NP101 (sumatriptan iontophoretic transdermal patch).
Subjects who continue to be in good health (use of a triptan or use of an NP101 patch is not contraindicated) and received treatment (patch activation) with the study patch for a qualifying migraine under study NP101-007 will be considered eligible for enrollment into the open-label study. Subjects will be expected to remain in the study for up to 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NP101 | Experimental | sumatriptan iontophoretic transdermal patch |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NP101 | Drug | NP101 study patch 4 hour application |
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| Measure | Description | Time Frame |
|---|---|---|
| Subject Self-examination of Skin Irritation | For each patch application, subjects performed a self-examination of skin irritation using a 5-point scale (0=no redness; 1=minimal skin redness; 2=moderate skin redness with sharp borders; 3=intense skin redness with or without swelling; 4=intense skin redness with blisters or broken skin). | 24 hours post patch activation |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Relief | Headache pain relief (no pain or mild headache pain) at two hours post activation of NP101. | 2 hours |
| Nausea Free | Nausea free at two hours after patch activation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Pierce, MD PhD | NuPathe Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22352764 | Derived | Smith TR, Goldstein J, Singer R, Pugach N, Silberstein S, Pierce MW. Twelve-month tolerability and efficacy study of NP101, the sumatriptan iontophoretic transdermal system. Headache. 2012 Apr;52(4):612-24. doi: 10.1111/j.1526-4610.2012.02094.x. Epub 2012 Feb 21. |
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This was an open-label study to assess the long-term safety of NP101. Subjects who continued to be in good health and received treatment with an NP101 patch for a qualifying migraine in the pivotal NP101-007 study were considered eligible for enrollment.
The study was initiated January 2009 and completed in September 2010. Patients were enrolled from 34 investigative sites across the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | NP101 | The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 2 hours |
| Phonophobia Free | Phonophobia free at two hours after patch activation. | 2 hours |
| Photophobia Free | Photophobia free at two hours after patch activation. | 2 hours |
| Little Rock |
| Arkansas |
| United States |
| Newport Beach | California | United States |
| San Francisco | California | United States |
| Santa Monica | California | United States |
| Fairfield | Connecticut | United States |
| Ocala | Florida | United States |
| Palm Beach Gardens | Florida | United States |
| Sunrise | Florida | United States |
| Atlanta | Georgia | United States |
| Columbus | Georgia | United States |
| Decatur | Georgia | United States |
| Savannah | Georgia | United States |
| Chicago | Illinois | United States |
| Ann Arbor | Michigan | United States |
| Kalamazoo | Michigan | United States |
| Springfield | Missouri | United States |
| St Louis | Missouri | United States |
| Mount Vernon | New York | United States |
| Plainview | New York | United States |
| Greensboro | North Carolina | United States |
| West Chester | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Philadelphia | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | United States |
| Wynnewood | Pennsylvania | United States |
| Memphis | Tennessee | United States |
| Nashville | Tennessee | United States |
| Dallas | Texas | United States |
| Houston | Texas | United States |
| San Antonio | Texas | United States |
| Alexandria | Virginia | United States |
| Virginia Beach | Virginia | United States |
| Seattle | Washington | United States |
| COMPLETED |
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| NOT COMPLETED |
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Per protocol, the intent-to-treat (ITT) population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Of the 183 subjects who applied at least one study patch, 181 subjects met the ITT criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | NP101 | The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | 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 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Pain Relief | Headache pain relief (no pain or mild headache pain) at two hours post activation of NP101. | Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Two treated subjects in the safety population did not meet this criteria. | Posted | Number | participants | 2 hours |
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| Primary | Subject Self-examination of Skin Irritation | For each patch application, subjects performed a self-examination of skin irritation using a 5-point scale (0=no redness; 1=minimal skin redness; 2=moderate skin redness with sharp borders; 3=intense skin redness with or without swelling; 4=intense skin redness with blisters or broken skin). | Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). | Posted | Mean | Standard Deviation | scores on a scale | 24 hours post patch activation | NP101 Patches | Participants |
|
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| Secondary | Nausea Free | Nausea free at two hours after patch activation. | Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Two treated subjects in the safety population did not meet this criteria. | Posted | Number | participants | 2 hours |
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| Secondary | Phonophobia Free | Phonophobia free at two hours after patch activation. | Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Two treated subjects in the safety population did not meet this criteria. | Posted | Number | participants | 2 hours |
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| Secondary | Photophobia Free | Photophobia free at two hours after patch activation. | Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Two treated subjects in the safety population did not meet this criteria. | Posted | Number | participant | 2 hours |
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All adverse events were collected from study enrollment until 30 days after the last patch application.
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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 | NP101 | The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period. | 2 | 183 | 66 | 183 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site hypersensitivity | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Application Site Pain | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Application site pruritus | General disorders | MedDRA (10.0) | Systematic Assessment |
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Per the study agreement, Investigators have the right to publish or present information and/or data arising from the study, provided the text of any such publication or presentation is submitted for review at least thirty days prior to submission for publication or other disclosure and NuPathe shall have the right to request the removal of any confidential information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Pierce, MD PhD | NuPathe Inc. | 484-567-0130 | mpierce@nupathe.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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| NP101 Patches |
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