NCT01986088

Eletriptan vs Sumatriptan: A Double-blind, Placebo-controlled, Multiple Migraine Attack Study

A Multicentre, Double Blind, Double Dummy, Parallel Group, Placebo Controlled, Study of Two Dose Levels of Oral Eletriptan and Two Dose Levels Oral Sumatriptan Given for the Acute Treatment of Migraine(With and Without Aura).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,008 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years – 76 Years
• Healthy volunteers: Not accepted

Summary

A previously published, placebo-controlled, head-to-head comparator study found eletriptan to have superior efficacy to oral sumatriptan 100 mg in treating a single acute migraine attack. The goal of the current study was to extend the findings of that study by examining the efficacy of eletriptan compared with both 50- and 100-mg doses of sumatriptan; and to evaluate the comparative efficacy of eletriptan and sumatriptan across additional important clinical outcomes. In particular, early response (at 1 hour), sustained response (without need for additional treatment) at 24 hours, and consistency of response across multiple attacks were examined.

Conditions

• Migraine With or Without Aura

Interventions

Type	Name	Description
DRUG	Placebo	matching placebo
DRUG	Eletriptan 40 mg	40mg oral
DRUG	Eletriptan 80 mg	80mg oral
DRUG	Sumatriptan 50 mg	50mg oral
DRUG	Sumatriptan 100 mg	100mg oral

Timeline

• Start date: 1996-11-01
• Primary completion: 1998-01-01
• Completion: 1998-01-01
• First posted: 2013-11-18
• Last updated: 2021-01-28