Eletriptan Provides Consistent Migraine Relief: Results Of A Within-Patient Multiple-Dose Study

Viatris

Status and phase: Completed; Phase 3

Conditions: Migraine With Aura; Migraine Without Aura

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01859481

A1601015

Details and patient eligibility

About

Evaluation of headache response at 2 hours for active treated attacks for increasing dose.

Enrollment: 971 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male and Female subjects in good general health, aged 18 to 65 years.
• Subjects should meet IHS diagnostic criteria for migraine with or without aura.
• Based on past history, subjects should expect to suffer at least one acute attack of migraine with or without aura, each 6 weeks

Exclusion criteria

• Known coronary-artery disease, clinically significant arrhythmia, heart failure, or uncontrolled hypertension.
• Pregnant or lactating women.
• Clinically significant electrocardiogram abnormalities at screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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971 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Eletriptan HBr 40 mg

Experimental group

Treatment:

Drug: Eletriptan HBr 40 mg

Eletriptan HBr 80 mg

Experimental group

Treatment:

Drug: Eletriptan HBr 80 mg