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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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: 1
NP101 - sumatriptan iontophoretic transdermal patch
|
Drug: NP101
NP101 sumatriptan iontophoretic transdermal patch
|
|
Placebo Comparator: 2
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
Show 34 Study Locations| Study Director: | Angel S Angelov, MD | NuPathe Inc. |
More Information
| Responsible Party: | Angel S. Angelov, M.D., NuPathe Inc. |
| ClinicalTrials.gov Identifier: | NCT00724815 History of Changes |
| Other Study ID Numbers: | PROT-15-NP101-007 |
| Study First Received: | July 28, 2008 |
| Last Updated: | July 30, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Sumatriptan Vasoconstrictor Agents Cardiovascular Agents |
Therapeutic Uses Pharmacologic Actions Serotonin 5-HT1 Receptor Agonists Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |