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

Phase 3

Completed

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

• Registration Number: NCT01989936
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 1999-01
• Primary Completion: 2000-09
• Study Completion: 2000-09
• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-11-20
• Study First Posted: 2013-11-21
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 446

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint was 2-h headache response after taking the first dose of study medication for the first attack	18 weeks	Subjects recorded the intensity of each migraine headache in the diary based on a 4-point scale: 0, pain absent; 1, mild pain; 2, moderate pain; 3, severe pain. A response was considered a change from severe or moderate pain to mild or absent at various time points after dosing with study medication

Secondary Outcome Measures

Name	Time	Method
Sustained response was defined as achieving a headache response within 2 h post dose, with no recurrence or rescue medication needed	18 weeks	Recurrence was defined as a return of headache to moderate or severe intensity within 2-24 h if the subject had an initial response within 2 h of taking the study medication.

Trial Locations

Locations (43)

Arhus Kommunehospital; 🇩🇰 Arhus C, Denmark

Centralsygehuset I Esbjerg; 🇩🇰 Esbjerg, Denmark

Kas Glostrup; 🇩🇰 Glostrup, Denmark

Hilleroed Sygehus; 🇩🇰 Hilleroed, Denmark

Knud Kjaersgaard Pedersen; 🇩🇰 Hjorring, Denmark

Bispebjerg Hospital; 🇩🇰 København, Denmark

Neubauer, Ole (Private Practice); 🇩🇰 Nykoebing F, Denmark

Korsgaard, Anne G. (Private Practice); 🇩🇰 Odense C, Denmark

Haukiputaan Laakarikeskus; 🇫🇮 Haukipudas, Finland

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland

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