Efficacy and Safety of Eletriptan for the Treatment of Migraine in Patients Not Satisfied With Rizatriptan Therapy
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ClinicalTrials.gov Identifier: NCT00632385 |
Recruitment Status
:
Completed
First Posted
: March 10, 2008
Last Update Posted
: April 26, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Migraine | Drug: Eletriptan | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 127 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-label Study of Eletriptan for the Acute Treatment of Migraine in Migraine Sufferers Who Are Dissatisfied With Rizatriptan Therapy |
Study Start Date : | January 2003 |
Actual Study Completion Date : | August 2003 |

Arm | Intervention/treatment |
---|---|
Experimental: A |
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
|
- Change from baseline in headache pain severity [ Time Frame: 1, 2, 4, and 24 hours ]
- Functional impairment [ Time Frame: 1, 2, 4, and 24 hours ]
- Work Productivity Questionnaire [ Time Frame: Week 10 ]
- Time Loss [ Time Frame: Week 10 ]
- Subject Preference Questionnaire [ Time Frame: Week 10 ]
- Global Evaluation [ Time Frame: Week 10 ]
- Subject Satisfaction Scale [ Time Frame: Week 10 ]
- Associated Symptoms [ Time Frame: 1, 2, 4, and 24 hours ]
- Use of Rescue Medication [ Time Frame: Week 10 ]
- Adverse events [ Time Frame: Week 10 ]
- Vital signs [ Time Frame: Week 10 ]
- Physical examination [ Time Frame: Week 10 ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00632385
United States, California | |
Pfizer Investigational Site | |
Irvine, California, United States, 92618 | |
Pfizer Investigational Site | |
Newport Beach, California, United States, 92660-2452 | |
Pfizer Investigational Site | |
San Francisco, California, United States, 94109 | |
United States, Florida | |
Pfizer Investigational Site | |
Plantation, Florida, United States, 33324 | |
Pfizer Investigational Site | |
St Petersburg, Florida, United States, 33710 | |
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 | |
Chesterfield, Missouri, United States, 63017 | |
Pfizer Investigational Site | |
Springfield, Missouri, United States, 65804 | |
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 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc |
ClinicalTrials.gov Identifier: | NCT00632385 History of Changes |
Other Study ID Numbers: |
A1601092 |
First Posted: | March 10, 2008 Key Record Dates |
Last Update Posted: | April 26, 2011 |
Last Verified: | April 2011 |
Additional relevant MeSH terms:
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Rizatriptan |
Eletriptan Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |