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

Viatris

Status and phase: Completed; Phase 3

Conditions: Migraine With or Without Aura

Treatments: Drug: Eletriptan 80 mg; Drug: Sumatriptan 25 mg; Drug: Eletriptan 40 mg; Drug: Sumatriptan 50 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01986270

A160-104

Details and patient eligibility

About

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.

Enrollment: 1,141 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,141 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 25 mg

Experimental group

Treatment:

Drug: Sumatriptan 25 mg

Sumatriptan 50 mg

Experimental group

Treatment:

Drug: Sumatriptan 50 mg