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Multiple Attacks Study to Compare the Efficacy and Safety of MK-0974 With Placebo for Acute Migraine (MK-0974-031)

Primary Purpose

Migraines

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Telcagepant 140 mg
Talcagepant 280 mg
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraines focused on measuring multiple attacks of moderate to severe migraine headaches

Eligibility Criteria

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

Inclusion Criteria:

  • History of migraines within the past year
  • 1 to 8 moderate or severe migraine attacks per month in the past 2 months that lasted between 4 to 72 hours if untreated
  • Use acceptable contraception throughout the study
  • Able to complete the study questionnaire(s) and paper diary
  • Limit consumption of grapefruit juice to no more than one 8 ounce glass a day

Exclusion Criteria:

  • Pregnant or breast-feeding or is expecting to become pregnant during the study
  • Difficulty distinguishing his/her migraine attacks from tension or interval headaches
  • A history of mostly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours
  • More than 15 headache-days per month or has taken medication for acute headache on more than 10 days a month in the past 3 months
  • Greater than 50 years old at the age of migraine onset
  • Previously taken telcagepant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Placebo Comparator

    Arm Label

    Telcagepant 140 mg

    Telcagepant 280 mg

    Control Group 1

    Control Group 2

    Arm Description

    Telcagepant 140 mg, oral, tablet, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.

    Telcagepant 280 mg, oral, tablet, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.

    Placebo, oral, tablet, across 3 migraine attacks (1st, 2nd, and 4th). Telcagepant 140 mg will be administered for the 3rd migraine attack. Participants will receive placebo for the optional second dose. For migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.

    Placebo, oral, tablet, across 3 migraine attacks (1st, 2nd, and 3rd). Telcagepant 140 mg will be administered for the 4th migraine attack. Participants will receive placebo for the optional second dose. For migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.

    Outcomes

    Primary Outcome Measures

    Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack)
    Pain Freedom (PF) at 2 hours post-dose (first migraine attack), with pain freedom defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.
    Percentage of Participants Reporting Pain Relief at 2 Hours Post-dose (First Migraine Attack)
    Pain Relief (PR) at 2 hours post-dose (first migraine attack), with pain relief defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.
    Percentage of Participants Reporting Pain Freedom Consistency at 2 Hours Post-dose
    Pain Freedom Consistency (PFC) at 2 hours post-dose, defined as having achieved PF at 2 hours post-dose on at least 3 treated migraine attacks. Note that for the control groups, a positive PF response arising from the administration of the 1 talcagepant treated migraine attack will count as one of the 3 positive PF responses needed to fulfill the criteria for PFC.
    Percentage of Participants Reporting Pain Relief Consistency at 2 Hours Post-dose
    Pain Relief Consistency (PRC) at 2 hours post-dose, defined as having achieved PR at 2 hours post-dose on at least 3 treated migraine attacks. Note that for the control groups, a positive PR response arising from the administration of the 1 telcagepant treated migraine attack will count as one of the 3 positive PR responses needed to fulfill the criteria for PRC.
    Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-dose (First Migraine Attack)
    The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points.
    Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-dose (First Migraine Attack)
    The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points.
    Percentage of Participants Reporting Absence of Nausea 2 Hours Post-dose (First Migraine Attack)
    The participant recorded whether nausea was present or absent at each of the predefined time points.
    Number of Participants Experiencing an Adverse Event (AE) Within 48 Hours Post-dose (First Migraine Attack)
    AEs were reported following treatment for the first migraine attack using a 48-hour post-dose window. AEs displayed are those reported by at least 4 participants in one or more treatment groups.
    Number of Participants Discontinuing Study Medication Due to an AE
    Participants discontinuing study medication due to an AE were reported for all migraine attacks.

    Secondary Outcome Measures

    Percentage of Participants Reporting Sustained Pain Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)
    Sustained Pain Freedom (SPF) from 2 to 24 hours after study medication administration. SPF from 2 to 24 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with the study medication.
    Percentage of Participants Reporting Sustained Pain Freedom From 2 to 48 Hours Post-dose (First Migraine Attack)
    Sustained Pain Freedom (SPF) from 2 to 48 hours post-dose after study medication administration. SPF from 2 to 48 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 48 hours after dosing with the study medication.
    Percentage of Participants Reporting Total Migraine Freedom at 2 Hours Post-dose (First Migraine Attack)
    TMF 2 hours post-dose, which is defined as TMF at 2 hours post-dose, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache and no reported occurrence of photophobia, phonophobia, nausea, or vomiting during the 2 hours after dosing with the study medication.
    Percentage of Participants Reporting Total Migraine Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)
    TMF from 2 to 24 hours post-dose, which is defined as TMF at 2 hours post-dose, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache and no reported occurrence of photophobia, phonophobia, nausea, or vomiting during the 2 to 24 hours after dosing with the study medication.

    Full Information

    First Posted
    May 15, 2007
    Last Updated
    September 18, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00483704
    Brief Title
    Multiple Attacks Study to Compare the Efficacy and Safety of MK-0974 With Placebo for Acute Migraine (MK-0974-031)
    Official Title
    A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Multiple Attacks Study to Compare the Efficacy and Safety of Oral MK-0974 With Placebo for the Acute Treatment of Migraine With or Without Aura
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 14, 2008 (Actual)
    Primary Completion Date
    March 25, 2009 (Actual)
    Study Completion Date
    March 25, 2009 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of the study is to assess the safety and efficacy of telcagepant (MK-0974) in acute treatment of multiple migraine attacks with or without aura. Primary hypotheses of this study are that telcagepant is superior to placebo, as measured by the proportion of participants who have pain freedom, pain relief, pain freedom consistency, pain relief consistency, and absence of photophobia, phonophobia, and nausea at 2 hours post-dose.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Migraines
    Keywords
    multiple attacks of moderate to severe migraine headaches

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1935 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Telcagepant 140 mg
    Arm Type
    Experimental
    Arm Description
    Telcagepant 140 mg, oral, tablet, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
    Arm Title
    Telcagepant 280 mg
    Arm Type
    Experimental
    Arm Description
    Telcagepant 280 mg, oral, tablet, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
    Arm Title
    Control Group 1
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo, oral, tablet, across 3 migraine attacks (1st, 2nd, and 4th). Telcagepant 140 mg will be administered for the 3rd migraine attack. Participants will receive placebo for the optional second dose. For migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
    Arm Title
    Control Group 2
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo, oral, tablet, across 3 migraine attacks (1st, 2nd, and 3rd). Telcagepant 140 mg will be administered for the 4th migraine attack. Participants will receive placebo for the optional second dose. For migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
    Intervention Type
    Drug
    Intervention Name(s)
    Telcagepant 140 mg
    Intervention Description
    Telcagepant 140 mg tablets
    Intervention Type
    Drug
    Intervention Name(s)
    Talcagepant 280 mg
    Intervention Description
    Telcagepant 280 mg tablets
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo tablets
    Primary Outcome Measure Information:
    Title
    Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack)
    Description
    Pain Freedom (PF) at 2 hours post-dose (first migraine attack), with pain freedom defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.
    Time Frame
    2 hours post-dose for the first migraine attack (up to 6 months)
    Title
    Percentage of Participants Reporting Pain Relief at 2 Hours Post-dose (First Migraine Attack)
    Description
    Pain Relief (PR) at 2 hours post-dose (first migraine attack), with pain relief defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.
    Time Frame
    2 hours post-dose for the first migraine attack (up to 6 months)
    Title
    Percentage of Participants Reporting Pain Freedom Consistency at 2 Hours Post-dose
    Description
    Pain Freedom Consistency (PFC) at 2 hours post-dose, defined as having achieved PF at 2 hours post-dose on at least 3 treated migraine attacks. Note that for the control groups, a positive PF response arising from the administration of the 1 talcagepant treated migraine attack will count as one of the 3 positive PF responses needed to fulfill the criteria for PFC.
    Time Frame
    2 hours post-dose (up to 6 months)
    Title
    Percentage of Participants Reporting Pain Relief Consistency at 2 Hours Post-dose
    Description
    Pain Relief Consistency (PRC) at 2 hours post-dose, defined as having achieved PR at 2 hours post-dose on at least 3 treated migraine attacks. Note that for the control groups, a positive PR response arising from the administration of the 1 telcagepant treated migraine attack will count as one of the 3 positive PR responses needed to fulfill the criteria for PRC.
    Time Frame
    2 hours post-dose (up to 6 months)
    Title
    Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-dose (First Migraine Attack)
    Description
    The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points.
    Time Frame
    2 hours post-dose for the first migraine attack (up to 6 months)
    Title
    Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-dose (First Migraine Attack)
    Description
    The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points.
    Time Frame
    2 hours post-dose for the first migraine attack (up to 6 months)
    Title
    Percentage of Participants Reporting Absence of Nausea 2 Hours Post-dose (First Migraine Attack)
    Description
    The participant recorded whether nausea was present or absent at each of the predefined time points.
    Time Frame
    2 hours post-dose for the first migraine attack (up to 6 months)
    Title
    Number of Participants Experiencing an Adverse Event (AE) Within 48 Hours Post-dose (First Migraine Attack)
    Description
    AEs were reported following treatment for the first migraine attack using a 48-hour post-dose window. AEs displayed are those reported by at least 4 participants in one or more treatment groups.
    Time Frame
    Up to 48 hours post-dose for the first migraine attack (up to 6 months)
    Title
    Number of Participants Discontinuing Study Medication Due to an AE
    Description
    Participants discontinuing study medication due to an AE were reported for all migraine attacks.
    Time Frame
    Up to the 4th dose of study medication (up to 6 months)
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants Reporting Sustained Pain Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)
    Description
    Sustained Pain Freedom (SPF) from 2 to 24 hours after study medication administration. SPF from 2 to 24 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with the study medication.
    Time Frame
    From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)
    Title
    Percentage of Participants Reporting Sustained Pain Freedom From 2 to 48 Hours Post-dose (First Migraine Attack)
    Description
    Sustained Pain Freedom (SPF) from 2 to 48 hours post-dose after study medication administration. SPF from 2 to 48 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 48 hours after dosing with the study medication.
    Time Frame
    From 2 to 48 hours post-dose for the first migraine attack (up to 6 months)
    Title
    Percentage of Participants Reporting Total Migraine Freedom at 2 Hours Post-dose (First Migraine Attack)
    Description
    TMF 2 hours post-dose, which is defined as TMF at 2 hours post-dose, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache and no reported occurrence of photophobia, phonophobia, nausea, or vomiting during the 2 hours after dosing with the study medication.
    Time Frame
    2 hours post-dose for the first migraine attack (up to 6 months)
    Title
    Percentage of Participants Reporting Total Migraine Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)
    Description
    TMF from 2 to 24 hours post-dose, which is defined as TMF at 2 hours post-dose, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache and no reported occurrence of photophobia, phonophobia, nausea, or vomiting during the 2 to 24 hours after dosing with the study medication.
    Time Frame
    From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: History of migraines within the past year 1 to 8 moderate or severe migraine attacks per month in the past 2 months that lasted between 4 to 72 hours if untreated Use acceptable contraception throughout the study Able to complete the study questionnaire(s) and paper diary Limit consumption of grapefruit juice to no more than one 8 ounce glass a day Exclusion Criteria: Pregnant or breast-feeding or is expecting to become pregnant during the study Difficulty distinguishing his/her migraine attacks from tension or interval headaches A history of mostly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours More than 15 headache-days per month or has taken medication for acute headache on more than 10 days a month in the past 3 months Greater than 50 years old at the age of migraine onset Previously taken telcagepant
    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

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    20974601
    Citation
    Ho AP, Dahlof CG, Silberstein SD, Saper JR, Ashina M, Kost JT, Froman S, Leibensperger H, Lines CR, Ho TW. Randomized, controlled trial of telcagepant over four migraine attacks. Cephalalgia. 2010 Dec;30(12):1443-57. doi: 10.1177/0333102410370878. Epub 2010 Jun 8.
    Results Reference
    derived
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/study.html?id=0974-031&kw=0974-031&tab=access

    Learn more about this trial

    Multiple Attacks Study to Compare the Efficacy and Safety of MK-0974 With Placebo for Acute Migraine (MK-0974-031)

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