MedTrace Logo

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

NCT00724815 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 530

Last updated 2016-02-04

Study results available
· View outcomes & findings →

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.

Conditions

  • Migraine Disorders

Interventions

DRUG

NP101 - Sumatriptan iontophoretic transdermal patch

Sumatriptan iontophoretic transdermal patch

DRUG

Placebo

NP101 Placebo iontophoretic transdermal patch

Sponsors & Collaborators

  • NuPathe Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Pierce, MD · NuPathe Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00724815 on ClinicalTrials.gov