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

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).

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01986088

Enrollment

1008

Registered

2013-11-18

Start date

1996-11-30

Completion date

1998-01-31

Last updated

2021-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine With or Without Aura

Brief 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.

Interventions

DRUGPlacebo

matching placebo

DRUGEletriptan 40 mg

40mg oral

DRUGEletriptan 80 mg

80mg oral

DRUGSumatriptan 50 mg

50mg oral

DRUGSumatriptan 100 mg

100mg oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 76 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Headache response at 1 hour after treatment of 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

Measure	Time frame
Headache severity	.5, 1, 2, 4 and 24 hours
Pain-free response	.5, 1, 2, 4 and 24 hours
Functional response	.5, 1, 2, 4 and 24 hours
Presence or absence of nausea, photophobia, and phonophobia	.5, 1, 2, 4 and 24 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026