Comparative Study of Oral Eletriptan (40mg and 80mg), Oral Sumatriptan (25mg and 50mg) and Placebo

A Multicenter, Double-blind, Placebo Controlled, Parallel Group, Study of Two Dose Levels of Oral Eletriptan and Two Dose Levels of of Oral Sumatriptan Given for the Acute Treatment of Migraine

The objective of this study was to compare the efficacy, toleration and safety of eletriptan 40mg and 80mg, with sumatriptan 25mg and 50mg, and placebo when given orally to subjects with an acute migraine.

Study Overview

• Status: Completed
• Conditions: Migraine With or Without Aura
• Intervention / Treatment: Drug: Placebo; Drug: Eletriptan 40 mg; Drug: Eletriptan 80 mg; Drug: Sumatriptan 25 mg; Drug: Sumatriptan 50 mg

• Study Type: Interventional
• Enrollment (Actual): 1141
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects who expected to suffer at least one acute attack of migraine, with or without aura, each 6 weeks (The diagnosis of migraine was to comply with the criteria proposed by the International Headache Society (IHS))
• Subjects capable of taking medication as outpatients, and recording the effects of such medication.

Exclusion Criteria:

• Pregnant or breast-feeding women
• Migraine subjects who also suffered from concomitant frequent (non-migrainous) headache, defined as more than six attacks per month on average.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• 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 25 mg	Drug: Sumatriptan 25 mg; 25mg oral
EXPERIMENTAL: Sumatriptan 50 mg	Drug: Sumatriptan 50 mg; 50mg oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache response at 1 hour after the first dose for 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	Measure Description	Time Frame
Pain-free response at 1 hour after the first dose for the first attack.	A pain free response was defined as an improvement from a severe or moderate headache at baseline to an absent headache post-dose.	1 hour

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: December 1, 1996
• Primary Completion (ACTUAL): January 1, 1998
• Study Completion (ACTUAL): January 1, 1998

Study Registration Dates

• First Submitted: October 30, 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: A160-104