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| Sponsor: | NuPathe Inc. |
|---|---|
| Information provided by: | NuPathe Inc. |
| ClinicalTrials.gov Identifier: | NCT00724815 |
Purpose
This study will use a randomized, parallel group, double-blind, placebo controlled design to compare the efficacy and tolerability of NP101 to a placebo iontophoretic transdermal patch. Adult subjects who meet the enrollment criteria will be randomized in a 1:1 ratio and stratified by race into one of two treatment groups: NP101 - sumatriptan iontophoretic transdermal patch or placebo iontophoretic transdermal patch.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine Disorders |
Drug: NP101 Drug: NP101 placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study |
| Official Title: | The Efficacy and Tolerability of NP101, a Sumatriptan Iontophoretic Transdermal Patch, in the Treatment of Acute Migraine: A Randomized, Double-Blind, Placebo-Controlled Study |
| Enrollment: | 530 |
| Study Start Date: | July 2008 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
NP101 - sumatriptan iontophoretic transdermal patch
|
Drug: NP101
NP101 sumatriptan iontophoretic transdermal patch
|
|
2: Placebo Comparator
Placebo iontophoretic transdermal patch
|
Drug: NP101 placebo
Placebo iontophoretic transdermal patch
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Phoenix, Arizona, United States | |
| United States, Arkansas | |
| Little Rock, Arkansas, United States | |
| United States, California | |
| San Francisco, California, United States | |
| Santa Monica, California, United States | |
| Newport Beach, California, United States | |
| United States, Connecticut | |
| Fairfield, Connecticut, United States | |
| United States, Florida | |
| Sunrise, Florida, United States | |
| Palm Beach Gardens, Florida, United States | |
| Ocala, Florida, United States | |
| United States, Georgia | |
| Atlanta, Georgia, United States | |
| Decatur, Georgia, United States | |
| Savannah, Georgia, United States | |
| Columbus, Georgia, United States | |
| United States, Illinois | |
| Chicago, Illinois, United States | |
| United States, Michigan | |
| Kalamazoo, Michigan, United States | |
| Ann Arbor, Michigan, United States | |
| United States, Missouri | |
| Springfield, Missouri, United States | |
| St. Louis, Missouri, United States | |
| United States, New York | |
| Mount Vernon, New York, United States | |
| Plainview, New York, United States | |
| United States, North Carolina | |
| Greensboro, North Carolina, United States | |
| United States, Ohio | |
| West Chester, Ohio, United States | |
| United States, Oklahoma | |
| Oklahoma City, Oklahoma, United States | |
| United States, Pennsylvania | |
| Pittsburgh, Pennsylvania, United States | |
| Wynnewood, Pennsylvania, United States | |
| Philadelphia, Pennsylvania, United States | |
| United States, Tennessee | |
| Nashville, Tennessee, United States | |
| Memphis, Tennessee, United States | |
| United States, Texas | |
| Dallas, Texas, United States | |
| Houston, Texas, United States | |
| San Antonio, Texas, United States | |
| United States, Virginia | |
| Virginia Beach, Virginia, United States | |
| Alexandria, Virginia, United States | |
| United States, Washington | |
| Seattle, Washington, United States | |
| Study Director: | Angel S Angelov, MD | NuPathe Inc. |
More Information
| Responsible Party: | NuPathe Inc. ( Angel S. Angelov, M.D. ) |
| Study ID Numbers: | PROT-15-NP101-007 |
| Study First Received: | July 28, 2008 |
| Last Updated: | July 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00724815 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Migraine Disorders Nervous System Diseases Central Nervous System Diseases |
Headache Disorders, Primary Brain Diseases Headache Disorders |