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

Phase 3

Completed

• Conditions: Migraine With or Without Aura
• Interventions: Drug: Placebo; Drug: Eletriptan 20 mg; Drug: Eletriptan 40 mg; Drug: Eletriptan 80 mg

• Registration Number: NCT01978496
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1996-07
• Primary Completion: 1997-12
• Study Completion: 1997-12
• Study First Submitted: 2013-10-31
• Study First Submitted QC: 2013-10-31
• Study First Posted: 2013-11-07
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1334

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Eletriptan 20 mg	Eletriptan 20 mg	-
Eletriptan 40 mg	Eletriptan 40 mg	-
Eletriptan 80 mg	Eletriptan 80 mg	-

Primary Outcome Measures

Name	Time	Method
Headache responder rate at two hours after the first dose for the first attack.	2 hours	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.

Secondary Outcome Measures

Name	Time	Method
Pain free responder rate at two hours after the first dose for the first attack.	2 hours	Pain free response was defined as improvement from grade 2 or 3 at baseline to grade 0 at two hours post-dose.