A Study to Assess an Auto-injector Being Used to Treat a Migraine Attack
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00510419
First received: August 1, 2007
Last updated: June 6, 2012
Last verified: June 2012
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Purpose
The purpose of this research study is to evaluate an investigational auto-injector system for delivering sumatriptan under the skin for a single migraine attack.
The study could take approximately 5 weeks and will include about 3 office visits to the study doctor, the patient will be contacted every 2 weeks until the patient experiences a migraine and uses the auto-injector. The last visit will be done by a telephone follow-up call.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine |
Drug: "Investigational"Auto-injector (sumatriptan succinate) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 3 Open-Label Study to Assess Subcutaneous Self-Injection With Sumatriptan Succinate Using an Auto-injector During a Single Migraine Attack |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Successful administration and acceptability of self-injection of sumatriptan under the skin using an investigational auto-injector will be assessed by use of patient-completed scales and a short questionnaire.
Secondary Outcome Measures:
- • Comparison of pain scores pre-dose and 2 hours post-dose. • Preference of investigational auto-injector experience compared to subject's previous self-administration of sumatriptan.
| Enrollment: | 73 |
| Study Start Date: | July 2007 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Investigational Plan:
- Screening Visit [Visit 0 / 0-14 days prior to receipt of study drug]
- Baseline Visit [Visit 1 / Provision of study drug and subject training]
- Treatment Visit [Visit 2 / within 72 hours after study drug administration]
- Follow-up Visit [Visit 3 / Telephone follow-up 7-10 days after study drug administration]
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adults 18 to 60 years of age
- Prior effective use of injectable sumatriptan on at least two occasions within the last two months
- At least two migraines per month suitable injectable sumatriptan
- Capable of using a migraine self-injection auto-injector
- Capable of distinguishing between migraine and other headache types (e.g., tension-type headache)
Exclusion Criteria:
- Seizure disorders
- Coronary artery disease (CAD)
- Cardiac dysrhythmia or pacemaker
- High blood pressure
- Liver disease
- Kidney disease
- Autoimmune disease
- History of alcohol or substance abuse
- Currently pregnant
- Use of any other investigational drug product within 30 days prior to treatment visit
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510419
Locations
| United States, California | |
| San Francisco Clinical Research Center | |
| San Francisco, California, United States, 94109 | |
| United States, Connecticut | |
| New England Center for Headache | |
| Stamford, Connecticut, United States, 06902 | |
| United States, Illinois | |
| Diamond Head Clinic | |
| Chicago, Illinois, United States, 60614 | |
| United States, Michigan | |
| Michigan Head Pain & Neurological Institute | |
| Ann Arbor, Michigan, United States, 48104 | |
| United States, Missouri | |
| Clinvest | |
| Springfield, Missouri, United States, 65807 | |
| United States, Pennsylvania | |
| University of Pittsburgh Headache Center | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Tennessee | |
| Wesley Headache Clinic | |
| Memphis, Tennessee, United States, 38018 | |
| United States, Texas | |
| Anodyne Headache and Pain Care | |
| Dallas, Texas, United States, 75231 | |
| Houston Headache Clinic | |
| Houston, Texas, United States, 77004 | |
| Road Runner Research, LTD | |
| San Antonio, Texas, United States, 78258 | |
Sponsors and Collaborators
Pfizer
More Information
No publications provided by Pfizer
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00510419 History of Changes |
| Other Study ID Numbers: | K644-07-3001 |
| Study First Received: | August 1, 2007 |
| Last Updated: | June 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Migraine |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 23, 2013