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NCT00806546 · ClinicalTrials.gov registry record · Phase 3

An Open-Label Study to Evaluate the Safety of NP101 in the Treatment of Acute Migraine Over Twelve Months

A Phase 3 study, sponsored by NuPathe.

Completed
Registry status
Phase 3
Development phase
514
Enrollment target

NCT00806546: Completed Phase 3 study, sponsored by NuPathe.

NCT00806546 is a Phase 3 study that has completed, run by NuPathe. The registered enrollment target is 514 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00806546, a Phase 3 study, has completed, sponsored by NuPathe.

COMPLETED
Registry status
Phase 3
Development phase
514 participants
Enrollment target

Study Summary

This study will use an open-label design to evaluate the safety of NP101. Adult subjects who meet the enrollment criteria will be treated with NP101 (sumatriptan succinate iontophoretic transdermal patch) for acute migraine attacks over a 12 month period.

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

FieldValue
Enrollment Target 514 participants
Start Date 2009-02
Est. Completion 2011-05
Phase Phase 3
NuPathe

7 total trials

What the finished NCT00806546 record still lists

NCT00806546 is an interventional study that assigns participants to a tested intervention. The registered 514 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 (33% lower).

The record links to 0 conditions, and to 1 intervention - of which NP101 is the first listed.

NCT00806546 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00806546 about?

NCT00806546 is a clinical study titled "An Open-Label Study to Evaluate the Safety of NP101 in the Treatment of Acute Migraine Over Twelve Months". This study will use an open-label design to evaluate the safety of NP101. Adult subjects who meet the enrollment criteria will be treated with NP101 (sumatriptan succinate iontophoretic transdermal patch) for acute migraine attacks over a 12 month period.

What is the current status of trial NCT00806546?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 514 participants. The study started on 2009-02. Estimated completion is 2011-05.

What interventions are being tested in trial NCT00806546?

The interventions under investigation include: NP101 (DRUG).

Who is sponsoring clinical trial NCT00806546?

This trial is sponsored by NuPathe, which has 7 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00806546's enrollment target sits among peer trials

514 724th of 2000 higher than 1,274 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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Source: ClinicalTrials.gov NCT00806546, the US trial registry maintained by the National Library of Medicine. NCT00806546 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.