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| Sponsor: | NuPathe Inc. |
|---|---|
| Information provided by: | NuPathe Inc. |
| ClinicalTrials.gov Identifier: | NCT00806546 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine Disorders |
Drug: NP101 |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
| Official Title: | An Open-Label Study to Evaluate the Safety of NP101, a Sumatriptan Iontophoretic Transdermal Patch, in the Treatment of Acute Migraine Over 12 Months |
| Estimated Enrollment: | 400 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | February 2011 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
NP101: Experimental
sumatriptan iontophoretic transdermal patch
|
Drug: NP101
NP101 study patch four hour application
|
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 31 Study Locations
More Information
| Responsible Party: | NuPathe Inc. ( Angel S. Angelov, MD, Senior Medical Director ) |
| Study ID Numbers: | PROT-15-NP101-009 |
| Study First Received: | December 10, 2008 |
| Last Updated: | February 5, 2010 |
| ClinicalTrials.gov Identifier: | NCT00806546 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 |