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Study of Telcagepant (MK-0974) in Participants With Moderate to Severe Acute Migraine With or Without Aura (MK-0974-011)

Primary Purpose

Migraine

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Telcagepant potassium 150 mg
Telcagepant potassium 300 mg
Zolmitriptan 5 mg
Placebo to telcagepant 150 mg
Placebo to tecagepant 300 mg
Placebo to zolmitriptan 5 mg
Rescue medication
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has at least 1 year history of migraine (with or without aura)
  • Females of child bearing potential must use acceptable contraception throughout trial.

Exclusion Criteria:

  • Is pregnant/breast-feeding (or is a female expecting to conceive during study period)
  • Has history or evidence of stroke/transient ischemic attacks, heart disease, coronary artery vasospasm, other significant underlying cardiovascular diseases, uncontrolled hypertension (high blood pressure), uncontrolled diabetes, or human immunodeficiency virus (HIV) disease
  • Has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
  • Has a history of gastric, or small intestinal surgery, or has a disease that causes malabsorption
  • Has a history of cancer within the last 5 years.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    Telcagepant 150 mg

    Telcagepant 300 mg

    Zolmitriptan 5 mg

    Placebo

    Arm Description

    Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.

    Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.

    Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.

    Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.

    Outcomes

    Primary Outcome Measures

    Number of Participants With Pain Freedom (PF) at 2 Hours Post-Dose
    Participants were asked to rate their migraine headache severity with ratings of 0=No pain, 1=Mild pain, 2=Moderate pain, and 3=Severe pain. PF at 2 hours post-dose is defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at baseline to no pain (Grade 0) at 2 hours post-dose.
    Number of Participants With Pain Relief (PR) at 2 Hours Post-Dose
    Participants were asked to rate their migraine headache severity with ratings of 0=No pain, 1=Mild pain, 2=Moderate pain, and 3=Severe pain. PR at 2 hours post-dose is defined as a shift from a moderate or severe migraine headache (Grade 2 or 3) at baseline to mild or no pain (Grade 1 or 0) at 2 hours post-dose.
    Number of Participants With Absence of Photophobia at 2 Hours Post-Dose
    Participants were asked if they experienced any sensitivity to light. The number of participants who experienced no photophobia (sensitivity to light) at 2 hours post-dose was determined.
    Number of Participants With Absence of Phonophobia at 2 Hours Post-Dose
    Participants were asked if they experienced any sensitivity to sound. The number of participants who experienced no phonophobia (sensitivity to sound) at 2 hours post-dose was determined.
    Number of Participants With Absence of Nausea at 2 Hours Post-Dose
    Participants were asked if they experienced any nausea. The number of participants who experienced no nausea at 2 hours post-dose was determined.
    Number of Participants Who Experience At Least One Adverse Event (AE)
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 14 days after last dose study drug. Participants who took both active and placebo study drug were counted in the active group.
    Number of Participants Who Discontinue Study Drug Due to an AE
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants who took both active and placebo study drug were counted in the active group.

    Secondary Outcome Measures

    Number of Participants With Sustained Pain Freedom (SPF) From 2 to 24 Hours Post-Dose
    SPF is defined as PF at 2 hours post-dose with no return of mild/moderate/severe headache through 24 hours post-dose, and with no administration of either the optional second dose of study drug or any rescue medication between 2 and 24 hours post-dose.
    Number of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose
    TMF at 2 hours post-dose is defined as PF at 2 hours post-dose without any of the following migraine-related symptoms: phonophobia, photophobia, nausea or vomiting at 2 hours post-dose.
    Number of Participants With Total Migraine Freedom (TMF) at 2 to 24 Hours Post-Dose
    TMF at 2 to 24 hours post-dose is defined as TMF at 2 hours post-dose with no administration of either the optional second dose of study drug or any rescue medication between 2 and 24 hours post-dose, no return of mild/moderate/severe headache within 24 hours and no presence of phonophobia, photophobia, nausea or vomiting within 24 hours post-dose.

    Full Information

    First Posted
    February 28, 2007
    Last Updated
    September 18, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00442936
    Brief Title
    Study of Telcagepant (MK-0974) in Participants With Moderate to Severe Acute Migraine With or Without Aura (MK-0974-011)
    Official Title
    A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Study to Compare the Response to a Single Treatment With Oral MK0974 With Placebo and Comparator in Subjects With Moderate to Severe Acute Migraine With or Without Aura
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    February 15, 2007 (Actual)
    Primary Completion Date
    October 2, 2007 (Actual)
    Study Completion Date
    October 2, 2007 (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 this study is to investigate the efficacy and safety of telcagepant (MK-0974) compared to an approved medication for acute migraine. This study was conducted as a "triple-dummy" design; for each dose of study drug, participants each received 3 forms of study drug (2 capsules of active and/or placebo and 1 tablet of active and/or placebo) and were instructed to take one of each form of study drug at dosing time. The primary hypotheses of this study are that telcagepant is superior to placebo in Pain Freedom at 2 Hours Post-Dose, Pain Relief at 2 Hours Post-Dose, Absence of Photophobia at 2 Hours Post-Dose, Absence of Phonophobia at 2 Hours Post-Dose and Absence of 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
    Migraine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1380 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Telcagepant 150 mg
    Arm Type
    Experimental
    Arm Description
    Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
    Arm Title
    Telcagepant 300 mg
    Arm Type
    Experimental
    Arm Description
    Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
    Arm Title
    Zolmitriptan 5 mg
    Arm Type
    Active Comparator
    Arm Description
    Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
    Intervention Type
    Drug
    Intervention Name(s)
    Telcagepant potassium 150 mg
    Intervention Description
    Telcagepant 150 mg liquid-filled soft gel capsules
    Intervention Type
    Drug
    Intervention Name(s)
    Telcagepant potassium 300 mg
    Intervention Description
    Telcagepant 300 mg liquid-filled soft gel capsules
    Intervention Type
    Drug
    Intervention Name(s)
    Zolmitriptan 5 mg
    Intervention Description
    Zolmitriptan 5 mg tablets
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo to telcagepant 150 mg
    Intervention Description
    Placebo to match telcagepant 150 mg liquid-filled soft gel capsules
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo to tecagepant 300 mg
    Intervention Description
    Placebo to match tecagepant 300 mg liquid-filled soft gel capsules
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo to zolmitriptan 5 mg
    Intervention Description
    Placebo to match zolmitriptan 5 mg tablets
    Intervention Type
    Drug
    Intervention Name(s)
    Rescue medication
    Intervention Description
    If moderate or severe migraine headache pain continues or recurs 2 hours after dose of study drug, participants are allowed to take an optional second dose of study drug or their own non-study rescue migraine medication, which may include analgesics (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs] or opiates), anti-emetics, or zolmitriptan. Triptans other than zolmitriptan and ergot derivatives are prohibited for 24 hours following the last dose of study drug.
    Primary Outcome Measure Information:
    Title
    Number of Participants With Pain Freedom (PF) at 2 Hours Post-Dose
    Description
    Participants were asked to rate their migraine headache severity with ratings of 0=No pain, 1=Mild pain, 2=Moderate pain, and 3=Severe pain. PF at 2 hours post-dose is defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at baseline to no pain (Grade 0) at 2 hours post-dose.
    Time Frame
    2 hours post-dose
    Title
    Number of Participants With Pain Relief (PR) at 2 Hours Post-Dose
    Description
    Participants were asked to rate their migraine headache severity with ratings of 0=No pain, 1=Mild pain, 2=Moderate pain, and 3=Severe pain. PR at 2 hours post-dose is defined as a shift from a moderate or severe migraine headache (Grade 2 or 3) at baseline to mild or no pain (Grade 1 or 0) at 2 hours post-dose.
    Time Frame
    2 hours post-dose
    Title
    Number of Participants With Absence of Photophobia at 2 Hours Post-Dose
    Description
    Participants were asked if they experienced any sensitivity to light. The number of participants who experienced no photophobia (sensitivity to light) at 2 hours post-dose was determined.
    Time Frame
    2 hours post-dose
    Title
    Number of Participants With Absence of Phonophobia at 2 Hours Post-Dose
    Description
    Participants were asked if they experienced any sensitivity to sound. The number of participants who experienced no phonophobia (sensitivity to sound) at 2 hours post-dose was determined.
    Time Frame
    2 hours post-dose
    Title
    Number of Participants With Absence of Nausea at 2 Hours Post-Dose
    Description
    Participants were asked if they experienced any nausea. The number of participants who experienced no nausea at 2 hours post-dose was determined.
    Time Frame
    2 hours post-dose
    Title
    Number of Participants Who Experience At Least One Adverse Event (AE)
    Description
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 14 days after last dose study drug. Participants who took both active and placebo study drug were counted in the active group.
    Time Frame
    Up to 14 days after last dose of study drug
    Title
    Number of Participants Who Discontinue Study Drug Due to an AE
    Description
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants who took both active and placebo study drug were counted in the active group.
    Time Frame
    Up to 48 hours after first dose of study drug
    Secondary Outcome Measure Information:
    Title
    Number of Participants With Sustained Pain Freedom (SPF) From 2 to 24 Hours Post-Dose
    Description
    SPF is defined as PF at 2 hours post-dose with no return of mild/moderate/severe headache through 24 hours post-dose, and with no administration of either the optional second dose of study drug or any rescue medication between 2 and 24 hours post-dose.
    Time Frame
    2 to 24 hours post-dose
    Title
    Number of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose
    Description
    TMF at 2 hours post-dose is defined as PF at 2 hours post-dose without any of the following migraine-related symptoms: phonophobia, photophobia, nausea or vomiting at 2 hours post-dose.
    Time Frame
    2 hours post-dose
    Title
    Number of Participants With Total Migraine Freedom (TMF) at 2 to 24 Hours Post-Dose
    Description
    TMF at 2 to 24 hours post-dose is defined as TMF at 2 hours post-dose with no administration of either the optional second dose of study drug or any rescue medication between 2 and 24 hours post-dose, no return of mild/moderate/severe headache within 24 hours and no presence of phonophobia, photophobia, nausea or vomiting within 24 hours post-dose.
    Time Frame
    2 to 24 hours post-dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Has at least 1 year history of migraine (with or without aura) Females of child bearing potential must use acceptable contraception throughout trial. Exclusion Criteria: Is pregnant/breast-feeding (or is a female expecting to conceive during study period) Has history or evidence of stroke/transient ischemic attacks, heart disease, coronary artery vasospasm, other significant underlying cardiovascular diseases, uncontrolled hypertension (high blood pressure), uncontrolled diabetes, or human immunodeficiency virus (HIV) disease Has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine) Has a history of gastric, or small intestinal surgery, or has a disease that causes malabsorption Has a history of cancer within the last 5 years.
    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
    19036425
    Citation
    Ho TW, Ferrari MD, Dodick DW, Galet V, Kost J, Fan X, Leibensperger H, Froman S, Assaid C, Lines C, Koppen H, Winner PK. Efficacy and tolerability of MK-0974 (telcagepant), a new oral antagonist of calcitonin gene-related peptide receptor, compared with zolmitriptan for acute migraine: a randomised, placebo-controlled, parallel-treatment trial. Lancet. 2008 Dec 20;372(9656):2115-23. doi: 10.1016/S0140-6736(08)61626-8. Epub 2008 Nov 25.
    Results Reference
    background
    PubMed Identifier
    21054362
    Citation
    Ho TW, Olesen J, Dodick DW, Kost J, Lines C, Ferrari MD. Antimigraine efficacy of telcagepant based on patient's historical triptan response. Headache. 2011 Jan;51(1):64-72. doi: 10.1111/j.1526-4610.2010.01790.x. Epub 2010 Nov 4.
    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=0974-011&kw=0974-011&tab=access

    Learn more about this trial

    Study of Telcagepant (MK-0974) in Participants With Moderate to Severe Acute Migraine With or Without Aura (MK-0974-011)

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