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

NCT00792103 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2016-02-04

Study results available
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Summary

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.

Conditions

  • Migraine Disorders

Interventions

DRUG

NP101

NP101 study patch 4 hour application

Sponsors & Collaborators

  • NuPathe Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Pierce, MD PhD · NuPathe Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00792103 on ClinicalTrials.gov