A Multi-Center, Open-Label, Randomized, Parallel-Group Study of the Effects of Eletriptan 40mg on Mild vs Moderate to Severe Pain Intensity of Migraine in Early Intervention.

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country220 target enrollmentMarch 2005

ConditionsMigraine

Drugseletriptan

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Migraine
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Enrollment: 220
Locations: 1
Primary Endpoint: To evaluate pain free response at 2 hours with eletriptan 40mg in mild pain compared to moderate to severe pain intensity of migraine in early intervention.
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the efficacy of early intervention (dosing within 2 hours of onset of the migraine attack) with eletriptan 40mg on mild versus moderate to severe pain intensity of migraine.

Registry

clinicaltrials.gov

Start Date

March 2005

End Date

October 2006

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

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

Eligibility Criteria

Inclusion Criteria

•Diagnosis of migraine with or without aura according to the recent IHS criteria.
•Migraine headaches must have been present for more than one year.
•History in the last 3 months of 1 to 4 acute attacks of migraine headache per month.

Exclusion Criteria

•Subjects with current or past history of coronary artery disease.
•Pregnant or breastfeeding women.
•Subjects who have chronic daily headaches.

Outcomes

Primary Outcomes

To evaluate pain free response at 2 hours with eletriptan 40mg in mild pain compared to moderate to severe pain intensity of migraine in early intervention.

Secondary Outcomes

To demonstrate the efficacy of early intervention with eletriptan 40mg on mild compared to moderate to severe migraine pain include the following clinical outcomes: pain-free at 0.5, 1, 1.5, 4 and 24 hours; sustained pain-free, migraine recurrence