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

Viatris

Status and phase: Completed; Phase 3

Conditions: Migraine With or Without Aura

Treatments: Drug: Placebo; Drug: Eletriptan 80 mg; Drug: Sumatriptan 100 mg; Drug: Sumatriptan 50 mg; Drug: Eletriptan 40 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01986088

A160-318

Details and patient eligibility

About

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.

Enrollment: 1,008 patients

Sex: All

Ages: 18 to 76 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,008 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Eletriptan 40 mg

Experimental group

Treatment:

Drug: Eletriptan 40 mg

Eletriptan 80 mg

Experimental group

Treatment:

Drug: Eletriptan 80 mg

Sumatriptan 50 mg

Experimental group

Treatment:

Drug: Sumatriptan 50 mg

Sumatriptan 100 mg

Experimental group

Treatment:

Drug: Sumatriptan 100 mg