Efficacy, Safety, and Tolerability of Oral Eletriptan for Treatment of Acute Migraine

Viatris

Status and phase: Completed; Phase 3

Conditions: Migraine With or Without Aura

Treatments: Drug: Eletriptan 40 mg; Drug: Placebo; Drug: Eletriptan 80 mg; Drug: Eletriptan 20 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01978496

A160-102

Details and patient eligibility

About

To confirm the efficacy of three dose levels of oral eletriptan relative to placebo in relieving symptoms of acute migraine and to further explore the dose response relationship of eletriptan.

Enrollment: 1,334 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of at least one typical attack of migraine with or without aura every 6 weeks, as defined by the International Headache Society (IHS) criteria.
• Capable of taking study medication as outpatients and recording its effects.

Exclusion criteria

• Pregnant or breast-feeding women
• Migraine subjects who also suffered from concomitant frequent (non-migraine) headache, defined as more than six headaches per month on average
• Migraine attacks that were thought to be atypical and had consistently failed to respond to medical therapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,334 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Eletriptan 20 mg

Experimental group

Treatment:

Drug: Eletriptan 20 mg

Eletriptan 40 mg

Experimental group

Treatment:

Drug: Eletriptan 40 mg

Eletriptan 80 mg

Experimental group

Treatment:

Drug: Eletriptan 80 mg