|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Zogenix, Inc. |
|---|---|
| Information provided by: | Zogenix, Inc. |
| ClinicalTrials.gov Identifier: | NCT00530517 |
Purpose
Intraject is a needle-free, single use, disposable, subcutaneous delivery system pre-filled with 6mg Sumatriptan to be used by patients to treat acute migraine treatment. Study participation will last one month and include 2 doctor visits and 2-4 phone calls.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine Headache |
Device: Intraject Sumatriptan |
Phase II |
| Study Type: | Interventional |
| Study Design: | Open Label, Active Control, Single Group Assignment |
| Official Title: | A Multi-Center, Open-Label, Single-Dose, Single-Arm Study to Evaluate the Usability of Subcutaneously Administered Sumatriptan Delivered Via the Intraject® System in Adult Patients During Acute Migraine Attack |
| Enrollment: | 54 |
| Study Start Date: | September 2007 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Device: Intraject Sumatriptan
needle-free, single use, disposable, subcutaneous delivery system pre-filled with 6mg Sumatriptan
|
This study will evaluate how patients will interact with the needle-free Intraject system during actual self-administration to the abdomen or thigh for treatment of migraine headache while outside the clinic.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Illinois | |
| Chicago, Illinois, United States, 60614 | |
| United States, Missouri | |
| Springfield, Missouri, United States, 65807 | |
| St. Louis, Missouri, United States, 63141 | |
| United States, Tennessee | |
| Nashville, Tennessee, United States, 37203 | |
| Principal Investigator: | Jan Brandes, MD | Nashville Neuroscience Group |
More Information
| Responsible Party: | Zogenix, Inc ( Stephen J. Farr, Ph.D/ President and COO ) |
| Study ID Numbers: | ZX001-0701 |
| Study First Received: | September 13, 2007 |
| Last Updated: | February 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00530517 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
migraine sumatripatan |
|
Serotonin Agonists Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Central Nervous System Diseases Headache Disorders, Primary Cardiovascular Agents |
Brain Diseases Pharmacologic Actions Headache Disorders Sumatriptan Serotonin Agents Migraine Disorders Therapeutic Uses Vasoconstrictor Agents |