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

Phase 3

Completed

• Conditions: Migraine With or Without Aura
• Interventions: Drug: Sumatriptan 25 mg; Drug: Sumatriptan 50 mg; Drug: Eletriptan 40 mg; Drug: Eletriptan 80 mg; Drug: Placebo

• Registration Number: NCT01986270
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1996-12
• Primary Completion: 1998-01
• Study Completion: 1998-01
• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-11-11
• Study First Posted: 2013-11-18
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1141

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sumatriptan 25 mg	Sumatriptan 25 mg	-
Sumatriptan 50 mg	Sumatriptan 50 mg	-
Eletriptan 40 mg	Eletriptan 40 mg	-
Eletriptan 80 mg	Eletriptan 80 mg	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Headache response at 1 hour after the first dose for the first attack.	1 hour	Headache response was defined as improvement from a severe or moderate headache at baseline to either a mild or absent headache post-dose.

Secondary Outcome Measures

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