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

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01986270
• Collaborator: (none)
• Enrollment: 1,141
• Arms: 5
• Duration (Months): 13

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Migraine With or Without Aura	Drug: Placebo; Drug: Eletriptan 40 mg; Drug: Eletriptan 80 mg; Drug: Sumatriptan 25 mg; Drug: Sumatriptan 50 mg	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1141 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Dec 1, 1996
• Actual Primary Completion Date: Jan 1, 1998
• Actual Study Completion Date: Jan 1, 1998

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT01986270
• Other Study ID Numbers: A160-104
• First Posted: Nov 18, 2013
• Last Update Posted: Jan 28, 2021
• Last Verified: Jan 1, 2021

• Additional relevant MeSH terms: Migraine Disorders; Sumatriptan; Eletriptan

Study Results

No Results Posted as of Jan 28, 2021