Efficacy, Safety, and Tolerability of Oral Eletriptan for Treatment of Acute Migraine

A Multicenter Double-blind, Randomized Placebo Controlled, Parallel Group, Study of the Efficacy and Safety of Oral Eletriptan in Subjects With Acute Migraine

To confirm the efficacy of three dose levels of oral eletriptan relative to placebo in relieving symptoms of acute migraine and to further explore the dose response relationship of eletriptan.

Study Overview

• Status: Completed
• Conditions: Migraine With or Without Aura
• Intervention / Treatment: Drug: Placebo; Drug: Eletriptan 20 mg; Drug: Eletriptan 40 mg; Drug: Eletriptan 80 mg

• Study Type: Interventional
• Enrollment (Actual): 1334
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• History of at least one typical attack of migraine with or without aura every 6 weeks, as defined by the International Headache Society (IHS) criteria.
• Capable of taking study medication as outpatients and recording its effects.

Exclusion Criteria:

• Pregnant or breast-feeding women
• Migraine subjects who also suffered from concomitant frequent (non-migraine) headache, defined as more than six headaches per month on average
• Migraine attacks that were thought to be atypical and had consistently failed to respond to medical therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; matching placebo
EXPERIMENTAL: Eletriptan 20 mg	Drug: Eletriptan 20 mg; 20mg oral
EXPERIMENTAL: Eletriptan 40 mg	Drug: Eletriptan 40 mg; 40mg oral
EXPERIMENTAL: Eletriptan 80 mg	Drug: Eletriptan 80 mg; 80mg oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache responder rate at two hours after the first dose for the first attack.	A headache response was defined as a subject having improvement in headache severity from grade 2 or 3 at baseline to 0 or 1 at two hours post-dose.	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain free responder rate at two hours after the first dose for the first attack.	Pain free response was defined as improvement from grade 2 or 3 at baseline to grade 0 at two hours post-dose.	2 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: July 1, 1996
• Primary Completion (ACTUAL): December 1, 1997
• Study Completion (ACTUAL): December 1, 1997

Study Registration Dates

• First Submitted: October 31, 2013
• First Submitted That Met QC Criteria: October 31, 2013
• First Posted (ESTIMATE): November 7, 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 Receptor Agonists; Eletriptan
• Other Study ID Numbers: A160-102