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

Phase 3

Completed

• Conditions: Migraine With Aura; Migraine Without Aura
• Interventions: Drug: Eletriptan HBr 80 mg; Drug: Placebo; Drug: Eletriptan HBr 40 mg

• Registration Number: NCT01859481
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2000-03
• Primary Completion: 2002-03
• Study Completion: 2002-03
• Study First Submitted: 2013-05-13
• Study First Submitted QC: 2013-05-17
• Study First Posted: 2013-05-22
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 971

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eletriptan HBr 80 mg	Eletriptan HBr 80 mg	-
Placebo	Placebo	-
Eletriptan HBr 40 mg	Eletriptan HBr 40 mg	-

Primary Outcome Measures

Name	Time	Method
Consistency of headache response (3 responses out of 3 active treated attacks) . Headache response was defined as migraine headache pain of moderate or severe intensity pre dose becoming basent or mild within 2 hours post dose.	24 weeks

Secondary Outcome Measures

Name	Time	Method
Consistency of headache response (2 responses out of 3 active treated attacks). Headache response was defined as migraine headache pain of moderate or severe intensity pre dose becoming basent or mild within 2 hours post dose.	24 weeks

Trial Locations

Locations (140)

Eeuwfeestkliniek; 🇧🇪 Antwerpen, Belgium

A.Z. Sint Jan; 🇧🇪 Brugge, Belgium

Cliniques Universitaires St Luc; 🇧🇪 Bruxelles, Belgium

C.H.U. de Charleroi; 🇧🇪 Charleroi, Belgium

Hopital de La Citadelle; 🇧🇪 Liege, Belgium

Faculty Hospital U Svety Anny; 🇨🇿 Brno, Czechia

Neurologika Klinika F.N.; 🇨🇿 Hradec Kralove, Czechia

Pain Centrum; 🇨🇿 Prague 2, Czechia

1St Medical Faculty of the Charles University; 🇨🇿 Prague 2, Czechia

Arhus Kommunehospital; 🇩🇰 Arhus C, Denmark

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