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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1008 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-11-30

Study Completion Date

1998-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Migraine With or Without Aura

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

matching placebo

Eletriptan 40 mg

Group Type EXPERIMENTAL

Eletriptan 40 mg

Intervention Type DRUG

40mg oral

Eletriptan 80 mg

Group Type EXPERIMENTAL

Eletriptan 80 mg

Intervention Type DRUG

80mg oral

Sumatriptan 50 mg

Group Type EXPERIMENTAL

Sumatriptan 50 mg

Intervention Type DRUG

50mg oral

Sumatriptan 100 mg

Group Type EXPERIMENTAL

Sumatriptan 100 mg

Intervention Type DRUG

100mg oral

Interventions

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Placebo

matching placebo

Intervention Type DRUG

Eletriptan 40 mg

40mg oral

Intervention Type DRUG

Eletriptan 80 mg

80mg oral

Intervention Type DRUG

Sumatriptan 50 mg

50mg oral

Intervention Type DRUG

Sumatriptan 100 mg

100mg oral

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No