Eletriptan vs Sumatriptan: A Double-blind, Placebo-controlled, Multiple Migraine Attack Study

Migraine With or Without Aura Clinical Trial

Official title:

A Multicentre, Double Blind, Double Dummy, Parallel Group, Placebo Controlled, Study of Two Dose Levels of Oral Eletriptan and Two Dose Levels Oral Sumatriptan Given for the Acute Treatment of Migraine(With and Without Aura).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01986088
• Other study ID #: A160-318
• Status: Completed
• Phase: Phase 3
• Start date: November 1996
• Est. completion date: January 1998

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A previously published, placebo-controlled, head-to-head comparator study found eletriptan to have superior efficacy to oral sumatriptan 100 mg in treating a single acute migraine attack. The goal of the current study was to extend the findings of that study by examining the efficacy of eletriptan compared with both 50- and 100-mg doses of sumatriptan; and to evaluate the comparative efficacy of eletriptan and sumatriptan across additional important clinical outcomes. In particular, early response (at 1 hour), sustained response (without need for additional treatment) at 24 hours, and consistency of response across multiple attacks were examined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1008
• Est. completion date: January 1998
• Est. primary completion date: January 1998
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 76 Years

Eligibility

Inclusion Criteria:

• Eligible patients were men and women with a minimum age limit of 18 years of age (in Canada there was also an age limit of 65 years) who were expected to have at least one attack of migraine with or without aura, as defined by the International Headache Society (IHS) criteria,15 every 6 weeks.
• Patients had to be capable of taking study medication as outpatients and recording the effects.

Exclusion Criteria:

• Pregnant or breast-feeding women and those not using adequate contraception were excluded from the trial.
• Patients with frequent nonmigrainous headache, atypical migraine that had not previously responded to therapy, migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, or migrainous infarction were excluded from the trial.

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine With or Without Aura

Intervention

Drug:
• Placebo
matching placebo
• Eletriptan 40 mg
40mg oral
• Eletriptan 80 mg
80mg oral
• Sumatriptan 50 mg
50mg oral
• Sumatriptan 100 mg
100mg oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache response at 1 hour after treatment of 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	Headache severity		.5, 1, 2, 4 and 24 hours
Secondary	Pain-free response		.5, 1, 2, 4 and 24 hours
Secondary	Functional response		.5, 1, 2, 4 and 24 hours
Secondary	Presence or absence of nausea, photophobia, and phonophobia		.5, 1, 2, 4 and 24 hours

External Links

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