An Open-Label Study to Evaluate the Safety of NP101 in the Treatment of Acute Migraine Over 12 Months (NP101-008)

February 2, 2016 updated by: NuPathe Inc.

An Open-Label Study to Evaluate the Safety of NP101, a Sumatriptan Iontophoretic Transdermal Patch, 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:

  • 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Newport Beach, California, United States
      • San Francisco, California, United States
      • Santa Monica, California, United States
    • Connecticut
      • Fairfield, Connecticut, United States
    • Florida
      • Ocala, Florida, United States
      • Palm Beach Gardens, Florida, United States
      • Sunrise, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Columbus, Georgia, United States
      • Decatur, Georgia, United States
      • Savannah, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Kalamazoo, Michigan, United States
    • Missouri
      • Springfield, Missouri, United States
      • St. Louis, Missouri, United States
    • New York
      • Mount Vernon, New York, United States
      • Plainview, New York, United States
    • North Carolina
      • Greensboro, North Carolina, United States
    • Ohio
      • West Chester, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
      • Wynnewood, Pennsylvania, United States
    • Tennessee
      • Memphis, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Alexandria, Virginia, United States
      • Virginia Beach, Virginia, United States
    • Washington
      • Seattle, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject was previously enrolled in study NP101-007 and treated (patch activation) a qualifying migraine.
  • Subject will be judged to be in good health, based upon the results of a medical history, physical examination, vital signs, and ECG. Subjects will not have any clinically significant abnormal vital signs or ECG parameters in order to qualify for enrollment. ECG must be done at enrollment for NP101-008 unless ECG for the Final Visit of study NP101-007 was conducted within 30 days.
  • Female subjects of childbearing potential (not surgically sterile or 2 years post menopausal) must have a negative pregnancy test at enrollment.

Exclusion Criteria:

  • Subject has less than two potential skin application sites.
  • Subject has clinically significant abnormal vital signs or ECG parameters or had an adverse event while participating in NP101-007 that would preclude the continued treatment with the NP101 patch.
  • Subject has had changes in their medical history or medication use that would preclude their use of sumatriptan as per the approved Imitrex® product Prescribing Information (PI) or their safe use of NP101 as per the NP101 Investigator's Brochure.
  • Subject has or plans to start, stop, change treatment or dose of any of the following within 3 months prior to the subject's study Enrollment date and through the Final Visit: anxiolytics, lithium and other mood stabilizers such as valproate, carbamazepine or lamotrigine, hypnotics or antipsychotics.
  • Subject has taken non-triptan serotonergic drugs including selective serotonin reuptake inhibitor (SSRI), serotonin and norepinephrine reuptake inhibitor (SNRI), tricyclic antidepressants (TCAs), monoamine oxidase inhibitor (MAOI) or preparations containing St. John's Wort within 1 month prior to enrollment and/or is planning to start any of these medications during the study (through Final Visit).
  • Female subjects who are pregnant, breast feeding, or of childbearing potential, and are not using or are unwilling to use an effective form of contraception during the study and for a period of 30 days following Final Visit. Acceptable methods of contraception include barrier method with spermicide, intrauterine device (IUD), steroidal contraceptive (oral, transdermal, implanted or injected) or abstinence. If the exclusive male partner is surgically sterile, this will be acceptable.
  • Subject has participated in a clinical study within 30 days of enrollment (excluding NP101-007) or is planning to participate in another clinical study for the duration of NP101-008.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NP101
sumatriptan iontophoretic transdermal patch
Drug: NP101
NP101 study patch 4 hour application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject Self-examination of Skin Irritation
Time Frame: 24 hours post patch activation
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).
24 hours post patch activation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Relief
Time Frame: 2 hours
Headache pain relief (no pain or mild headache pain) at two hours post activation of NP101.
2 hours
Nausea Free
Time Frame: 2 hours
Nausea free at two hours after patch activation.
2 hours
Phonophobia Free
Time Frame: 2 hours
Phonophobia free at two hours after patch activation.
2 hours
Photophobia Free
Time Frame: 2 hours
Photophobia free at two hours after patch activation.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NuPathe Inc.

Investigators

  • Study Chair: Mark Pierce, MD PhD, NuPathe Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

November 14, 2008

First Submitted That Met QC Criteria

November 14, 2008

First Posted (Estimate)

November 17, 2008

Study Record Updates

Last Update Posted (Estimate)

February 4, 2016

Last Update Submitted That Met QC Criteria

February 2, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROT-15-NP101-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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