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

Migraine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00634985
• Other study ID #: A1601085
• Status: Completed
• Phase: Phase 4
• Start date: November 2002
• Est. completion date: December 2003

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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

Locations

Country	Name	City	State
	Pfizer Investigational Site
Turkey	Pfizer Investigational Site	Capa	Istanbul
Turkey	Pfizer Investigational Site	Gaziantep
Turkey	Pfizer Investigational Site	Istanbul
Turkey	Pfizer Investigational Site	Izmir
Turkey	Pfizer Investigational Site	Samsun

Sponsors (1)

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

Country where clinical trial is conducted

Turkey, 

Outcome

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

External Links

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