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Eletriptan vs Sumatriptan: A Double-blind, Placebo-controlled, Multiple Migraine Attack Study

Primary Purpose

Migraine With or Without Aura

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Placebo
Eletriptan 40 mg
Eletriptan 80 mg
Sumatriptan 50 mg
Sumatriptan 100 mg
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine With or Without Aura

Eligibility Criteria

18 Years - 76 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Eligible patients were men and women with a minimum age limit of 18 years of age (in Canada there was also an age limit of 65 years) who were expected to have at least one attack of migraine with or without aura, as defined by the International Headache Society (IHS) criteria,15 every 6 weeks.
  • Patients had to be capable of taking study medication as outpatients and recording the effects.

Exclusion Criteria:

  • Pregnant or breast-feeding women and those not using adequate contraception were excluded from the trial.
  • Patients with frequent nonmigrainous headache, atypical migraine that had not previously responded to therapy, migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, or migrainous infarction were excluded from the trial.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Placebo

    Eletriptan 40 mg

    Eletriptan 80 mg

    Sumatriptan 50 mg

    Sumatriptan 100 mg

    Arm Description

    Outcomes

    Primary Outcome Measures

    Headache response at 1 hour after treatment of the first attack.
    Headache response was defined as improvement from a severe or moderate headache at baseline to either a mild or absent headache post-dose.

    Secondary Outcome Measures

    Headache severity
    Pain-free response
    Functional response
    Presence or absence of nausea, photophobia, and phonophobia

    Full Information

    First Posted
    November 11, 2013
    Last Updated
    January 26, 2021
    Sponsor
    Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01986088
    Brief Title
    Eletriptan vs Sumatriptan: A Double-blind, Placebo-controlled, Multiple Migraine Attack Study
    Official Title
    A Multicentre, Double Blind, Double Dummy, Parallel Group, Placebo Controlled, Study of Two Dose Levels of Oral Eletriptan and Two Dose Levels Oral Sumatriptan Given for the Acute Treatment of Migraine(With and Without Aura).
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1996 (undefined)
    Primary Completion Date
    January 1998 (Actual)
    Study Completion Date
    January 1998 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A previously published, placebo-controlled, head-to-head comparator study found eletriptan to have superior efficacy to oral sumatriptan 100 mg in treating a single acute migraine attack. The goal of the current study was to extend the findings of that study by examining the efficacy of eletriptan compared with both 50- and 100-mg doses of sumatriptan; and to evaluate the comparative efficacy of eletriptan and sumatriptan across additional important clinical outcomes. In particular, early response (at 1 hour), sustained response (without need for additional treatment) at 24 hours, and consistency of response across multiple attacks were examined.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Migraine With or Without Aura

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1008 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Title
    Eletriptan 40 mg
    Arm Type
    Experimental
    Arm Title
    Eletriptan 80 mg
    Arm Type
    Experimental
    Arm Title
    Sumatriptan 50 mg
    Arm Type
    Experimental
    Arm Title
    Sumatriptan 100 mg
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    matching placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Eletriptan 40 mg
    Intervention Description
    40mg oral
    Intervention Type
    Drug
    Intervention Name(s)
    Eletriptan 80 mg
    Intervention Description
    80mg oral
    Intervention Type
    Drug
    Intervention Name(s)
    Sumatriptan 50 mg
    Intervention Description
    50mg oral
    Intervention Type
    Drug
    Intervention Name(s)
    Sumatriptan 100 mg
    Intervention Description
    100mg oral
    Primary Outcome Measure Information:
    Title
    Headache response at 1 hour after treatment of the first attack.
    Description
    Headache response was defined as improvement from a severe or moderate headache at baseline to either a mild or absent headache post-dose.
    Time Frame
    1 hour
    Secondary Outcome Measure Information:
    Title
    Headache severity
    Time Frame
    .5, 1, 2, 4 and 24 hours
    Title
    Pain-free response
    Time Frame
    .5, 1, 2, 4 and 24 hours
    Title
    Functional response
    Time Frame
    .5, 1, 2, 4 and 24 hours
    Title
    Presence or absence of nausea, photophobia, and phonophobia
    Time Frame
    .5, 1, 2, 4 and 24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    76 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Eligible patients were men and women with a minimum age limit of 18 years of age (in Canada there was also an age limit of 65 years) who were expected to have at least one attack of migraine with or without aura, as defined by the International Headache Society (IHS) criteria,15 every 6 weeks. Patients had to be capable of taking study medication as outpatients and recording the effects. Exclusion Criteria: Pregnant or breast-feeding women and those not using adequate contraception were excluded from the trial. Patients with frequent nonmigrainous headache, atypical migraine that had not previously responded to therapy, migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, or migrainous infarction were excluded from the trial.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A160-318&StudyName=Eletriptan%20vs%20Sumatriptan%3A%20A%20double-blind%2C%20placebo-controlled%2C%20multiple%20migraine%20attack%20study
    Description
    To obtain contact information for a study center near you, click here.

    Learn more about this trial

    Eletriptan vs Sumatriptan: A Double-blind, Placebo-controlled, Multiple Migraine Attack Study

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