An Open-Label Study to Evaluate the Safety of NP101 in the Treatment of Acute Migraine Over 12 Months
Public ClinicalTrials.gov record NCT00792103. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label Study to Evaluate the Safety of NP101, a Sumatriptan Iontophoretic Transdermal Patch, in the Treatment of Acute Migraine Over 12 Months
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective is to evaluate the safety of long-term treatment with NP101 as assessed by: * Subject self-examination skin irritation scores * Adverse events * Changes in vital signs and ECG parameters The secondary objective is to evaluate the long term efficacy of NP101 as assessed by: * Headache pain free at two hours after patch activation for all initial acute migraine attacks treated with NP101 * Headache pain relief at two hours after patch activation for all initial acute migraine attacks treated with NP101 * Nausea free at two hours after patch activation for all initial acute migraine attacks treated with NP101 * Phonophobia free at two hours after patch activation for all initial acute migraine attacks treated with NP101 * Photophobia free at two hours after patch activation for all initial acute migraine attacks treated with NP101 * Migraine free at two hours after patch activation for all initial acute migraine attacks treated with NP101 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.
Study identification
- NCT ID
- NCT00792103
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 198 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2009 (Type not available)
- Primary completion
- Sep 2010 (Actual)
- Completion
- Sep 2010 (Actual)
- Last update posted
- Feb 4, 2016
2009 – 2010
United States locations
- U.S. sites
- 34
- U.S. states
- 18
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Phoenix | Arizona | — | — |
| Not listed | Little Rock | Arkansas | — | — |
| Not listed | Newport Beach | California | — | — |
| Not listed | San Francisco | California | — | — |
| Not listed | Santa Monica | California | — | — |
| Not listed | Fairfield | Connecticut | — | — |
| Not listed | Ocala | Florida | — | — |
| Not listed | Palm Beach Gardens | Florida | — | — |
| Not listed | Sunrise | Florida | — | — |
| Not listed | Atlanta | Georgia | — | — |
| Not listed | Columbus | Georgia | — | — |
| Not listed | Decatur | Georgia | — | — |
| Not listed | Savannah | Georgia | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Ann Arbor | Michigan | — | — |
| Not listed | Kalamazoo | Michigan | — | — |
| Not listed | Springfield | Missouri | — | — |
| Not listed | St Louis | Missouri | — | — |
| Not listed | Mount Vernon | New York | — | — |
| Not listed | Plainview | New York | — | — |
| Not listed | Greensboro | North Carolina | — | — |
| Not listed | West Chester | Ohio | — | — |
| Not listed | Oklahoma City | Oklahoma | — | — |
| Not listed | Philadelphia | Pennsylvania | — | — |
| Not listed | Pittsburgh | Pennsylvania | — | — |
| Not listed | Wynnewood | Pennsylvania | — | — |
| Not listed | Memphis | Tennessee | — | — |
| Not listed | Nashville | Tennessee | — | — |
| Not listed | Dallas | Texas | — | — |
| Not listed | Houston | Texas | — | — |
| Not listed | San Antonio | Texas | — | — |
| Not listed | Alexandria | Virginia | — | — |
| Not listed | Virginia Beach | Virginia | — | — |
| Not listed | Seattle | Washington | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00792103, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 4, 2016 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00792103 live on ClinicalTrials.gov.