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).

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.

Study Overview

• Status: Completed
• Conditions: Migraine With or Without Aura
• Intervention / Treatment: Drug: Placebo; Drug: Eletriptan 40 mg; Drug: Eletriptan 80 mg; Drug: Sumatriptan 50 mg; Drug: Sumatriptan 100 mg

• Study Type: Interventional
• Enrollment (Actual): 1008
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Eligible patients were men and women with a minimum age limit of 18 years of age (in Canada there was also an age limit of 65 years) who were expected to have at least one attack of migraine with or without aura, as defined by the International Headache Society (IHS) criteria,15 every 6 weeks.
• Patients had to be capable of taking study medication as outpatients and recording the effects.

Exclusion Criteria:

• Pregnant or breast-feeding women and those not using adequate contraception were excluded from the trial.
• Patients with frequent nonmigrainous headache, atypical migraine that had not previously responded to therapy, migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, or migrainous infarction were excluded from the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; matching placebo
Experimental: Eletriptan 40 mg	Drug: Eletriptan 40 mg; 40mg oral
Experimental: Eletriptan 80 mg	Drug: Eletriptan 80 mg; 80mg oral
Experimental: Sumatriptan 50 mg	Drug: Sumatriptan 50 mg; 50mg oral
Experimental: Sumatriptan 100 mg	Drug: Sumatriptan 100 mg; 100mg oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache response at 1 hour after treatment of the first attack.	Headache response was defined as improvement from a severe or moderate headache at baseline to either a mild or absent headache post-dose.	1 hour

Secondary Outcome Measures

Outcome Measure	Time Frame
Headache severity	.5, 1, 2, 4 and 24 hours
Pain-free response	.5, 1, 2, 4 and 24 hours
Functional response	.5, 1, 2, 4 and 24 hours
Presence or absence of nausea, photophobia, and phonophobia	.5, 1, 2, 4 and 24 hours

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: November 1, 1996
• Primary Completion (Actual): January 1, 1998
• Study Completion (Actual): January 1, 1998

Study Registration Dates

• First Submitted: November 11, 2013
• First Submitted That Met QC Criteria: November 11, 2013
• First Posted (Estimate): November 18, 2013

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Vasoconstrictor Agents; Sumatriptan; Eletriptan
• Other Study ID Numbers: A160-318