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NCT00724815 · ClinicalTrials.gov registry record · Phase 3

The Efficacy and Tolerability of NP101 Patch in the Treatment of Acute Migraine

A Phase 3 study, sponsored by NuPathe.

Completed
Registry status
Phase 3
Development phase
530
Enrollment target

NCT00724815: Completed Phase 3 study, sponsored by NuPathe.

NCT00724815 is a Phase 3 study that has completed, run by NuPathe. The registered enrollment target is 530 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00724815, a Phase 3 study, has completed, sponsored by NuPathe.

COMPLETED
Registry status
Phase 3
Development phase
530 participants
Enrollment target

Study Summary

This study was a randomized, parallel group, double-blind, placebo controlled design to compare the efficacy and tolerability of NP101 to a placebo iontophoretic transdermal patch. The primary objective of this study was to assess the proportion of subjects who were headache pain free at two hours after patch activation. Key secondary objectives included: 1. The proportion of subjects who were nausea free at two hours after patch activation. 2. The proportion of subjects who were photophobia free at two hours after patch activation. 3. The proportion of subjects who were phonophobia free at two hours after patch activation.

Primary Outcome

Subjects whose headache severity score equaled zero (0) two hours post patch activation and who had not received any rescue medication before their two-hour assessment.

Interventions

  • DRUG Placebo
  • DRUG NP101 - Sumatriptan iontophoretic transdermal patch

Trial Details

FieldValue
Enrollment Target 530 participants
Start Date 2009-01
Est. Completion 2009-07
Phase Phase 3
NuPathe

7 total trials

What the finished NCT00724815 record still lists

NCT00724815 is an interventional study that assigns participants to a tested intervention. The registered 530 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 (31% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00724815 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00724815 about?

NCT00724815 is a clinical study titled "The Efficacy and Tolerability of NP101 Patch in the Treatment of Acute Migraine". This study was a randomized, parallel group, double-blind, placebo controlled design to compare the efficacy and tolerability of NP101 to a placebo iontophoretic transdermal patch. The primary objective of this study was to assess the proportion of subjects who were headache pain free at two hours a...

What is the current status of trial NCT00724815?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 530 participants. The study started on 2009-01. Estimated completion is 2009-07.

What interventions are being tested in trial NCT00724815?

The interventions under investigation include: Placebo (DRUG), NP101 - Sumatriptan iontophoretic transdermal patch (DRUG).

Who is sponsoring clinical trial NCT00724815?

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

How this trial's enrollment target compares

Where NCT00724815's enrollment target sits among peer trials

530 706th of 2000 higher than 1,292 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 NCT00724815, the US trial registry maintained by the National Library of Medicine. NCT00724815 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.