findmyKOL
Clinical trialNCT00792103CompletedPhase 3Interventional

An Open-Label Study to Evaluate the Safety of NP101 in the Treatment of Acute Migraine Over 12 Months

SponsorNuPathe Inc.Enrollment198Migraine Disorders
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

34 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Facility name not stated

    Phoenix, Arizona, United States

  • Facility name not stated

    Little Rock, Arkansas, United States

  • Facility name not stated

    Newport Beach, California, United States

  • Facility name not stated

    San Francisco, California, United States

  • Facility name not stated

    Santa Monica, California, United States

  • Facility name not stated

    Fairfield, Connecticut, United States

  • Facility name not stated

    Ocala, Florida, United States

  • Facility name not stated

    Palm Beach Gardens, Florida, United States

  • Facility name not stated

    Sunrise, Florida, United States

  • Facility name not stated

    Atlanta, Georgia, United States

  • Facility name not stated

    Columbus, Georgia, United States

  • Facility name not stated

    Decatur, Georgia, United States

  • Facility name not stated

    Savannah, Georgia, United States

  • Facility name not stated

    Chicago, Illinois, United States

  • Facility name not stated

    Ann Arbor, Michigan, United States

  • Facility name not stated

    Kalamazoo, Michigan, United States

  • Facility name not stated

    Springfield, Missouri, United States

  • Facility name not stated

    St Louis, Missouri, United States

  • Facility name not stated

    Mount Vernon, New York, United States

  • Facility name not stated

    Plainview, New York, United States

  • Facility name not stated

    Greensboro, North Carolina, United States

  • Facility name not stated

    West Chester, Ohio, United States

  • Facility name not stated

    Oklahoma City, Oklahoma, United States

  • Facility name not stated

    Philadelphia, Pennsylvania, United States

  • Facility name not stated

    Pittsburgh, Pennsylvania, United States

  • Facility name not stated

    Wynnewood, Pennsylvania, United States

  • Facility name not stated

    Memphis, Tennessee, United States

  • Facility name not stated

    Nashville, Tennessee, United States

  • Facility name not stated

    Dallas, Texas, United States

  • Facility name not stated

    Houston, Texas, United States

  • Facility name not stated

    San Antonio, Texas, United States

  • Facility name not stated

    Alexandria, Virginia, United States

  • Facility name not stated

    Virginia Beach, Virginia, United States

  • Facility name not stated

    Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

NP101
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Jan 2009
Primary completion
30 Sept 2010
Completion
30 Sept 2010
Last update posted
4 Feb 2016
Registered enrollment
198
Registry id
NCT00792103

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.