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

NCT00806546 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 514

Last updated 2016-02-04

Study results available
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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.

Conditions

  • Migraine Disorders

Interventions

DRUG

NP101

NP101 study patch four hour application

Sponsors & Collaborators

  • NuPathe Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Pierce, M.D., PhD. · NuPathe Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2011-05-31
Completion
2011-05-31

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 NCT00806546 on ClinicalTrials.gov