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NCT00792103 · ClinicalTrials.gov registry record · Phase 3
An Open-Label Study to Evaluate the Safety of NP101 in the Treatment of Acute Migraine Over 12 Months
A Phase 3 study, sponsored by NuPathe.
- Completed
- Registry status
- Phase 3
- Development phase
- 198
- Enrollment target
NCT00792103: Completed Phase 3 study, sponsored by NuPathe.
NCT00792103 is a Phase 3 study that has completed, run by NuPathe. The registered enrollment target is 198 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00792103, a Phase 3 study, has completed, sponsored by NuPathe.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 198 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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).
Interventions
- DRUG NP101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 198 participants |
| Start Date | 2009-01 |
| Est. Completion | 2010-09 |
| Phase | Phase 3 |
What the finished NCT00792103 record still lists
NCT00792103 is an interventional study that assigns participants to a tested intervention. The registered 198 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 1 intervention - of which NP101 is the first listed.
NCT00792103 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00792103 about?
NCT00792103 is a clinical study titled "An Open-Label Study to Evaluate the Safety of NP101 in the Treatment of Acute Migraine Over 12 Months". 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: *...
What is the current status of trial NCT00792103?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 198 participants. The study started on 2009-01. Estimated completion is 2010-09.
What interventions are being tested in trial NCT00792103?
The interventions under investigation include: NP101 (DRUG).
Who is sponsoring clinical trial NCT00792103?
This trial is sponsored by NuPathe, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00792103's enrollment target sits among peer trials
198 1389th of 2000 higher than 611 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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