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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 is a Phase 3 study that has completed, run by NuPathe. The registered enrollment target is 198 participants.
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.
Interventions
- DRUG NP101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 198 participants |
| Start Date | 2009-01 |
| Est. Completion | 2010-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00792103
The ClinicalTrials.gov registry entry for NCT00792103 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 198 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NuPathe, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which NP101 is the first listed.
NCT00792103 reports 0 study locations.
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.
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