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

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00632385

Collaborator

(none)

127

Enrollment

Locations

Arm

Duration (Months)

7.9

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Migraine	Drug: Eletriptan	Phase 4

Study Design

Study Type:

Interventional

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 :

Jan 1, 2003

Actual Study Completion Date :

Aug 1, 2003

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change from baseline in headache pain severity [1, 2, 4, and 24 hours]

Secondary Outcome Measures

Functional impairment [1, 2, 4, and 24 hours]
Work Productivity Questionnaire [Week 10]
Time Loss [Week 10]
Subject Preference Questionnaire [Week 10]
Global Evaluation [Week 10]
Subject Satisfaction Scale [Week 10]
Associated Symptoms [1, 2, 4, and 24 hours]
Use of Rescue Medication [Week 10]
Adverse events [Week 10]
Vital signs [Week 10]
Physical examination [Week 10]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Irvine	California	United States	92618
2	Pfizer Investigational Site	Newport Beach	California	United States	92660-2452
3	Pfizer Investigational Site	San Francisco	California	United States	94109
4	Pfizer Investigational Site	Plantation	Florida	United States	33324
5	Pfizer Investigational Site	Saint Petersburg	Florida	United States	33710
6	Pfizer Investigational Site	Tampa	Florida	United States	33609
7	Pfizer Investigational Site	Marietta	Georgia	United States	30067
8	Pfizer Investigational Site	South Bend	Indiana	United States	46601
9	Pfizer Investigational Site	Milford	Massachusetts	United States	01757
10	Pfizer Investigational Site	Chesterfield	Missouri	United States	63017
11	Pfizer Investigational Site	Springfield	Missouri	United States	65804
12	Pfizer Investigational Site	Greensboro	North Carolina	United States	27403
13	Pfizer Investigational Site	Cincinnati	Ohio	United States	45219
14	Pfizer Investigational Site	Eugene	Oregon	United States	97401
15	Pfizer Investigational Site	San Antonio	Texas	United States	78229
16	Pfizer Investigational Site	Alexandria	Virginia	United States	22304

Sponsors and Collaborators

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00632385

Other Study ID Numbers:

A1601092

First Posted:

Mar 10, 2008

Last Update Posted:

Jan 27, 2021

Last Verified:

Jan 1, 2021

Additional relevant MeSH terms:

Migraine Disorders

Eletriptan

Study Results

No Results Posted as of Jan 27, 2021