Safety and Efficacy of Eletriptan for the Treatment of Migraine in Subjects Unsuccessfully Treated With Nonsteroidal Anti-inflammatory Drugs

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT00634985

Collaborator

(none)

120

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To assess the safety and efficacy of eletriptan for the treatment of migraine in subjects who had not been adequately treated with non-steroidal antiinflammatory drugs (NSAIDs)

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

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Multicentre, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Eletriptan 40 Mg for the Treatment of Migraine (With or Without Aura) in Subjects Unsuccessfully Treated With NSAIDS

Study Start Date :

Nov 1, 2002

Actual Study Completion Date :

Dec 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Drug: eletriptan 40 mg oral tablet for migraine attack; additional 40 mg oral tablet >2 hours from first dose if migraine reoccurred within 24 hours of achieving response

Arm

Intervention/Treatment

Experimental: A

Drug: eletriptan

40 mg oral tablet for migraine attack; additional 40 mg oral tablet >2 hours from first dose if migraine reoccurred within 24 hours of achieving response

Outcome Measures

Primary Outcome Measures

Headache severity and response post-treatment [2 hours]
Functional response post-treatment [2 hours]

Secondary Outcome Measures

Presence of associated symptoms including, nausea, vomiting, phonophobia, and photophobia at baseline and post-treatment [1, 2, 4, and 24 hours]
Migraine recurrence post-treatment [1, 2, 4, and 24 hours]
Time loss (from normal activities and from work) post-treatment [24 hours]
Subject preference and acceptability post-treatment [24 hours and 12 weeks]
Subject satisfaction post-treatment [2 and 24 hours]
Adverse events [Week 12]
Physical examination [Week 12]
Vital signs [Week 12]
Electrocardiogram [Week 12]
Headache severity and response at baseline and post-treatment [1, 4 and 24 hours]
Functional impairment severity and response at baseline and post-treatment [1, 4 and 24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Met International Headache Society diagnostic criteria for migraine with or without aura
Expected to suffer one to six acute migraine attacks per month based on past history
Experienced migraines for at least one year prior to entering study, and historically have not responded to NSAIDs

Exclusion Criteria:

Frequent migraine or frequent concomitant non-migrainous headache (average of >6 attacks per month)
Atypical migraines that consistently failed to respond to adequate medical therapy
Migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migrainous infarction, migraine aura without headache, or migraine with acute-onset aura

Contacts and Locations

Locations

	Site	City	State	Country
1	Pfizer Investigational Site	Capa	Istanbul	Turkey
2	Pfizer Investigational Site	Gaziantep		Turkey
3	Pfizer Investigational Site	Istanbul		Turkey
4	Pfizer Investigational Site	Izmir		Turkey
5	Pfizer Investigational Site	Samsun		Turkey
6	Pfizer Investigational Site

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:

NCT00634985

Other Study ID Numbers:

A1601085

First Posted:

Mar 13, 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