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NCT03282227 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Long-Term Safety of M207 in the Acute Treatment of Migraine
A Phase 3 study, sponsored by Zosano Pharma Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 342
- Enrollment target
NCT03282227: Completed Phase 3 study, sponsored by Zosano Pharma Corporation.
NCT03282227 is a Phase 3 study that has completed, run by Zosano Pharma Corporation. The registered enrollment target is 342 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03282227, a Phase 3 study, has completed, sponsored by Zosano Pharma Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 342 participants
- Enrollment target
Study Summary
This is an open-label, twelve-month safety study. There is a screening period followed by a run-in period to record migraine activity. Qualified subjects will receive study medication for up to twelve months for the treatment of multiple migraine attacks. Using the electronic diary (eDiary) to confirm they are experiencing a qualified migraine, subjects will self-administer the patches and respond to questions in the eDiary post treatment administration.
Primary Outcome
Number and % of subjects in safety population with any treatment-emergent adverse event(s) during the study. TEAE is defined as any new adverse event (AE) that started after first patch application. This was an open-label study with no control group. No statistical analyses were performed. Application site skin reactions including erythema, swelling, haemorrhage, bruise, pain, and pruritus were collected systematically via subject e-diary and/or investigator skin assessment at study visits. All
Interventions
- DRUG M207 Microneedle System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 342 participants |
| Start Date | 2017-11-07 |
| Est. Completion | 2019-05-17 |
| Phase | Phase 3 |
What the finished NCT03282227 record still lists
NCT03282227 is an interventional study that assigns participants to a tested intervention. The registered 342 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 (56% lower).
The record links to 0 conditions, and to 1 intervention - of which M207 Microneedle System is the first listed.
NCT03282227 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03282227 about?
NCT03282227 is a clinical study titled "A Study to Evaluate the Long-Term Safety of M207 in the Acute Treatment of Migraine". This is an open-label, twelve-month safety study. There is a screening period followed by a run-in period to record migraine activity. Qualified subjects will receive study medication for up to twelve months for the treatment of multiple migraine attacks. Using the electronic diary (eDiary) to confi...
What is the current status of trial NCT03282227?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 342 participants. The study started on 2017-11-07. Estimated completion is 2019-05-17.
What interventions are being tested in trial NCT03282227?
The interventions under investigation include: M207 Microneedle System (DRUG).
Who is sponsoring clinical trial NCT03282227?
This trial is sponsored by Zosano Pharma Corporation, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03282227's enrollment target sits among peer trials
342 1053rd of 2000 higher than 948 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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