A Study to Assess an Auto-injector Being Used to Treat a Migraine Attack - Full Text View

Sponsor:	King Pharmaceuticals
Information provided by:	King Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00510419

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 III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Succinic acid Sumatriptan Sumatriptan succinate

U.S. FDA Resources

Further study details as provided by King Pharmaceuticals:

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)

Detailed Description:

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

King Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	K644-07-3001
Study First Received:	August 1, 2007
Last Updated:	October 27, 2009
ClinicalTrials.gov Identifier:	NCT00510419 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by King Pharmaceuticals:

Migraine

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on November 09, 2009