Eletriptan for the Treatment of Migraine in Patients With Previous Poor Response or Tolerance to Oral Sumatriptan

Viatris

Status and phase

Completed

Phase 3

Conditions

Migraine With or Without Aura

Treatments

Drug: Placebo

Drug: Eletriptan 80 mg

Drug: Eletriptan 40 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01989936

A1601006

Details and patient eligibility

About

To determine the tolerability and efficacy of eletriptan in patients who had discontinued oral sumatriptan due to lack of efficacy or intolerable adverse events (AEs) during previous clinical treatment (not a controlled trial).

Enrollment

446 patients

Sex

All

Ages

18 to 68 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and female subjects age ≥ 18 years who met the International Headache Society (IHS) diagnostic criteria for migraine, with or without aura, and could reasonably expect to suffer at least one acute attack of migraine every 6 weeks.
Subjects required to have discontinued therapy with oral sumatriptan at least 2 weeks, but not longer than 2 years, prior to the screening visit.
Female subjects required to be adequately protected against pregnancy.

Exclusion criteria

pregnancy or breastfeeding, known coronary artery disease, significant arrhythmias, heart failure, significant ECG abnormalities, and uncontrolled hypertension.
Any significant systemic, organ, neurological, endocrine, metabolic, and psychological disorders reported by the patient or discovered during the physical examination
Subjects considered to have atypical migraine such as frequent attacks, prolonged aura or any migraine that was considered atypical.
Subjects who, during the course of the trial, required treatment with sumatriptan or any other 5-HT1B/1D agonist in addition to study medication.