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MK3207 for Treatment of Acute Migraines (3207-005)

Primary Purpose

Migraine

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK3207- 2.5 mg
MK3207- 5 mg
MK3207- 10 mg
MK3207- 20 mg
MK3207- 50 mg
MK3207- 100 mg
Comparator: placebo (unspecified)
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and Women from 18 to 65 years of age
  • 1+ year history of migraine that typically last from 4 to 72 hours if untreated
  • Had from 2 to 8 moderate or severe migraine attacks per month in the last 2 months
  • Not pregnant or planning to become pregnant in next 6 months

Exclusion Criteria:

  • Pregnant or breast-feeding, or planning to become pregnant in next 6 months
  • Cannot distinguish migraine attacks from tension type headaches
  • Migraines are mild or resolve without medication in less than 2 hours
  • More than 15 headache-days per month or have taken medication on more than 10 days per month in the last 3 months
  • Basilar type or hemiplegic migraine headaches
  • More than 50 years old when migraines began
  • History of cardiovascular disorder within last 6 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    3

    4

    5

    6

    7

    Arm Description

    MK3207- 2.5 mg

    MK3207- 5 mg

    MK3207- 10 mg

    MK3207- 20 mg

    MK3207- 50 mg

    MK3207- 100 mg

    Placebo

    Outcomes

    Primary Outcome Measures

    Pain Freedom (PF)
    Reduction of a Grade 2 or 3 severity migraine at baseline to Grade 0 at 2 hours postdose. Rating of Headache Severity (Scale from Grade 0 to 3): Grade 0: No pain Grade 1: Mild pain Grade 2: Moderate pain Grade 3: Severe pain

    Secondary Outcome Measures

    Pain Relief (PR)
    Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 0) at 2 hours postdose. Rating of Headache Severity (Scale from Grade 0 to 3): Grade 0: No pain Grade 1: Mild pain Grade 2: Moderate pain Grade 3: Severe pain
    Absence of Photophobia
    Absence of photophobia at 2 hours postdose as recorded by patient on paper diary.
    Absence of Phonophobia
    Absence of phonophobia at 2 hours postdose as recorded by patient on paper diary.
    Absence of Nausea
    Absence of nausea at 2 hours postdose as recorded by patient on paper diary.
    Sustained Pain Freedom (SPF)
    Pain freedom (Grade 0) at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with study medication.

    Full Information

    First Posted
    July 8, 2008
    Last Updated
    January 23, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00712725
    Brief Title
    MK3207 for Treatment of Acute Migraines (3207-005)
    Official Title
    A Phase IIb, Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-finding Study of MK3207 in the Treatment of Acute Migraine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2008 (undefined)
    Primary Completion Date
    January 2009 (Actual)
    Study Completion Date
    January 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of the study is to demonstrate the effectiveness and appropriate dosage level of MK3207 in the treatment of acute migraine.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Migraine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    676 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    MK3207- 2.5 mg
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    MK3207- 5 mg
    Arm Title
    3
    Arm Type
    Experimental
    Arm Description
    MK3207- 10 mg
    Arm Title
    4
    Arm Type
    Experimental
    Arm Description
    MK3207- 20 mg
    Arm Title
    5
    Arm Type
    Experimental
    Arm Description
    MK3207- 50 mg
    Arm Title
    6
    Arm Type
    Experimental
    Arm Description
    MK3207- 100 mg
    Arm Title
    7
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    MK3207- 2.5 mg
    Other Intervention Name(s)
    MK3207
    Intervention Description
    Arm 1: MK3207 2.5 mg taken after migraine onset.
    Intervention Type
    Drug
    Intervention Name(s)
    MK3207- 5 mg
    Other Intervention Name(s)
    MK3207
    Intervention Description
    Arm 2: MK3207 5 mg taken after migraine onset.
    Intervention Type
    Drug
    Intervention Name(s)
    MK3207- 10 mg
    Other Intervention Name(s)
    MK3207
    Intervention Description
    Arm 3: MK3207 10 mg taken after migraine onset.
    Intervention Type
    Drug
    Intervention Name(s)
    MK3207- 20 mg
    Other Intervention Name(s)
    MK3207
    Intervention Description
    Arm 4: MK3207 20 mg taken after migraine onset.
    Intervention Type
    Drug
    Intervention Name(s)
    MK3207- 50 mg
    Other Intervention Name(s)
    MK3207
    Intervention Description
    Arm 5: MK3207 50 mg taken after migraine onset.
    Intervention Type
    Drug
    Intervention Name(s)
    MK3207- 100 mg
    Other Intervention Name(s)
    MK3207
    Intervention Description
    Arm 6: MK3207 100 mg taken after migraine onset.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo (unspecified)
    Intervention Description
    Placebo taken after migraine onset.
    Primary Outcome Measure Information:
    Title
    Pain Freedom (PF)
    Description
    Reduction of a Grade 2 or 3 severity migraine at baseline to Grade 0 at 2 hours postdose. Rating of Headache Severity (Scale from Grade 0 to 3): Grade 0: No pain Grade 1: Mild pain Grade 2: Moderate pain Grade 3: Severe pain
    Time Frame
    2 hours postdose
    Secondary Outcome Measure Information:
    Title
    Pain Relief (PR)
    Description
    Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 0) at 2 hours postdose. Rating of Headache Severity (Scale from Grade 0 to 3): Grade 0: No pain Grade 1: Mild pain Grade 2: Moderate pain Grade 3: Severe pain
    Time Frame
    2 hours postdose
    Title
    Absence of Photophobia
    Description
    Absence of photophobia at 2 hours postdose as recorded by patient on paper diary.
    Time Frame
    2 hours postdose
    Title
    Absence of Phonophobia
    Description
    Absence of phonophobia at 2 hours postdose as recorded by patient on paper diary.
    Time Frame
    2 hours postdose
    Title
    Absence of Nausea
    Description
    Absence of nausea at 2 hours postdose as recorded by patient on paper diary.
    Time Frame
    2 hours postdose
    Title
    Sustained Pain Freedom (SPF)
    Description
    Pain freedom (Grade 0) at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with study medication.
    Time Frame
    2-24 hours postdose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Men and Women from 18 to 65 years of age 1+ year history of migraine that typically last from 4 to 72 hours if untreated Had from 2 to 8 moderate or severe migraine attacks per month in the last 2 months Not pregnant or planning to become pregnant in next 6 months Exclusion Criteria: Pregnant or breast-feeding, or planning to become pregnant in next 6 months Cannot distinguish migraine attacks from tension type headaches Migraines are mild or resolve without medication in less than 2 hours More than 15 headache-days per month or have taken medication on more than 10 days per month in the last 3 months Basilar type or hemiplegic migraine headaches More than 50 years old when migraines began History of cardiovascular disorder within last 6 months
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21383045
    Citation
    Hewitt DJ, Aurora SK, Dodick DW, Goadsby PJ, Ge YJ, Bachman R, Taraborelli D, Fan X, Assaid C, Lines C, Ho TW. Randomized controlled trial of the CGRP receptor antagonist MK-3207 in the acute treatment of migraine. Cephalalgia. 2011 Apr;31(6):712-22. doi: 10.1177/0333102411398399. Epub 2011 Mar 7.
    Results Reference
    result

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    MK3207 for Treatment of Acute Migraines (3207-005)

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