Efficacy and Safety of Eletriptan for the Treatment of Migraine in Patients Not Satisfied With Rizatriptan Therapy - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00632385

Purpose

To assess the efficacy and safety of eletriptan for migraine headaches in subjects who were not satisfied with rizatriptan therapy

Condition	Intervention	Phase
Migraine	Drug: Eletriptan	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Study of Eletriptan for the Acute Treatment of Migraine in Migraine Sufferers Who Are Dissatisfied With Rizatriptan Therapy

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Eletriptan Rizatriptan Rizatriptan Benzoate Eletriptan Hydrobromide

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from baseline in headache pain severity [ Time Frame: 1, 2, 4, and 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Functional impairment [ Time Frame: 1, 2, 4, and 24 hours ] [ Designated as safety issue: No ]
Work Productivity Questionnaire [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
Time Loss [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
Subject Preference Questionnaire [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
Global Evaluation [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
Subject Satisfaction Scale [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
Associated Symptoms [ Time Frame: 1, 2, 4, and 24 hours ] [ Designated as safety issue: No ]
Use of Rescue Medication [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: Week 10 ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: Week 10 ] [ Designated as safety issue: Yes ]
Physical examination [ Time Frame: Week 10 ] [ Designated as safety issue: Yes ]

Enrollment:	123
Study Start Date:	January 2003
Study Completion Date:	August 2003

Arms	Assigned Interventions
A: Experimental	Drug: Eletriptan 40 mg oral tablet for migraine attack, followed by 40 mg oral tablet if migraine reoccurred >2 hours from first dose and within 24 hours of first dose

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of migraine headache according to International Headache Society criteria and migraine headaches for at least 1 year
Eletriptan naive
Previously treated with rizatriptan and failed to achieve a satisfactory response within the past 12 months

Exclusion Criteria:

Non-migraine headaches on average more than 6 days per month or have less than 24 hours of freedom from headache between migraine attacks
Migraine attacks that are atypical or chronic daily headaches
A history of migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migrainous infarction, migraine aura without headache, migraine with acute onset aura

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632385

Locations

United States, California
Pfizer Investigational Site
San Francisco, California, United States, 94109
Pfizer Investigational Site
Newport Beach, California, United States, 92660-2452
Pfizer Investigational Site
IRVINE, California, United States, 92618
United States, Florida
Pfizer Investigational Site
St Petersburg, Florida, United States, 33710
Pfizer Investigational Site
Plantation, Florida, United States, 33324
Pfizer Investigational Site
TAMPA, Florida, United States, 33609
United States, Georgia
Pfizer Investigational Site
Marietta, Georgia, United States, 30067
United States, Indiana
Pfizer Investigational Site
SOUTH BEND, Indiana, United States, 46601
United States, Massachusetts
Pfizer Investigational Site
Milford, Massachusetts, United States, 01757
United States, Missouri
Pfizer Investigational Site
SPRINGFIELD, Missouri, United States, 65804
Pfizer Investigational Site
CHESTERFIELD, Missouri, United States, 63017
United States, North Carolina
Pfizer Investigational Site
GREENSBORO, North Carolina, United States, 27403
United States, Ohio
Pfizer Investigational Site
CINCINNATI, Ohio, United States, 45219
United States, Oregon
Pfizer Investigational Site
EUGENE, Oregon, United States, 97401
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Virginia
Pfizer Investigational Site
Alexandria, Virginia, United States, 22304

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A1601092
Study First Received:	March 3, 2008
Last Updated:	April 23, 2008
ClinicalTrials.gov Identifier:	NCT00632385 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Serotonin Agonists
Eletriptan
Neurotransmitter Agents
Migraine Disorders
Headache
Central Nervous System Diseases

Headache Disorders, Primary
Rizatriptan
Brain Diseases
Serotonin
Headache Disorders

Additional relevant MeSH terms:

Eletriptan
Serotonin Agonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Diseases

Headache Disorders, Primary
Rizatriptan
Brain Diseases
Pharmacologic Actions
Headache Disorders
Serotonin Agents
Migraine Disorders

ClinicalTrials.gov processed this record on September 10, 2009