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Telcagepant (MK-0974) Treatment of Migraine in Participants With Stable Vascular Disease (MK-0974-034)

Primary Purpose

Migraine Disorders, Heart Disease, Cerebrovascular Accident

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Telcagepant
Acetaminophen/Paracetamol
Placebo to Telcagepant
Placebo to Acetaminophen/Paracetamol
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Disorders

Eligibility Criteria

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

Inclusion Criteria:

  • Stable coronary artery disease for 3 months or more
  • 18 years of age or older with a history of migraine with or without aura
  • Must use acceptable contraception throughout the study

Exclusion Criteria:

  • Pregnant, breast-feeding, or planning to become pregnant during this study
  • 50 years of age or older when migraines began
  • Other pain syndromes that might interfere with study assessments, uncontrolled psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
  • History of gastric, or small intestinal surgery, or has a disease that causes malabsorption

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg

    Placebo and APAP 1000 mg→Telcagepant 300 mg

    Arm Description

    Participants receive up to 12 doses of telcagepant (280 mg tablet/capsule 300 mg), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.

    Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.

    Outcomes

    Primary Outcome Measures

    Percentage of Participants With Pain Freedom at 2 Hours Post-dose (Period 1, Migraine Attack 1)
    Pain Freedom (PF) at 2 hours post-dose (Period 1, Attack 1) defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at baseline to no pain (Grade 0). 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.
    Number of Participants Who Experienced an Adverse Event (AE) Within 14 Days Post-dose
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
    Number of Participants Discontinuing Study Drug Due to an AE Within 48 Hours Post-dose
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

    Secondary Outcome Measures

    Percentage of Participants With Pain Relief at 2 Hours Post-dose (Period 1, Migraine Attack 1)
    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.
    Number of Participants With a Confirmed Vascular Event Within 48 Hours Post-dose
    Confirmed Vascular Event included cardiac events, cerebrovascular events, and peripheral vascular events.
    Percentage of Participants With Absence of Phonophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)
    The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points.
    Percentage of Participants With Absence of Photophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)
    The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points.
    Percentage of Participants With Absence of Nausea at 2 Hours Post-dose (Period 1, Migraine Attack 1)
    The participant recorded whether nausea was present or absent at each of the predefined time points.
    Percentage of Participants With Sustained Pain Freedom (SPF) at 2 to 24 Hours Post-dose
    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.

    Full Information

    First Posted
    April 17, 2008
    Last Updated
    September 18, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00662818
    Brief Title
    Telcagepant (MK-0974) Treatment of Migraine in Participants With Stable Vascular Disease (MK-0974-034)
    Official Title
    A Multicenter, Randomized, Double-Blind, Placebo- and Active Controlled, Crossover Study to Evaluate the Safety and Efficacy of MK-0974 in the Treatment of Acute Migraine in Patients With Stable Vascular Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 17, 2008 (Actual)
    Primary Completion Date
    September 2, 2009 (Actual)
    Study Completion Date
    September 2, 2009 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the safety and efficacy of telcagepant in the treatment of acute migraine in participants with stable vascular disease. Acetaminophen/paracetamol (APAP) will be used as an active comparator in this study. The primary hypothesis of this study is that telcagepant 300 mg is superior to placebo.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Migraine Disorders, Heart Disease, Cerebrovascular Accident, TIA (Transient Ischemic Attack), Vascular Diseases, Peripheral Vascular Diseases

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg
    Arm Type
    Experimental
    Arm Description
    Participants receive up to 12 doses of telcagepant (280 mg tablet/capsule 300 mg), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.
    Arm Title
    Placebo and APAP 1000 mg→Telcagepant 300 mg
    Arm Type
    Experimental
    Arm Description
    Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.
    Intervention Type
    Drug
    Intervention Name(s)
    Telcagepant
    Intervention Description
    Telcagepant (MK-0974) (300 mg soft gel capsules or 280 mg tablets)
    Intervention Type
    Drug
    Intervention Name(s)
    Acetaminophen/Paracetamol
    Intervention Description
    Acetaminophen/Paracetamol (500 mg X 2 dosage units)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo to Telcagepant
    Intervention Description
    Placebo 300 mg soft gel capsules or placebo 280 mg tablet.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo to Acetaminophen/Paracetamol
    Intervention Description
    Placebo to acetaminophen/paracetamol (500 mg X 2 dosage units)
    Primary Outcome Measure Information:
    Title
    Percentage of Participants With Pain Freedom at 2 Hours Post-dose (Period 1, Migraine Attack 1)
    Description
    Pain Freedom (PF) at 2 hours post-dose (Period 1, Attack 1) defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at baseline to no pain (Grade 0). 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 (Up to 6 weeks)
    Title
    Number of Participants Who Experienced an Adverse Event (AE) Within 14 Days Post-dose
    Description
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
    Time Frame
    Within 14 days of any dose of study medication (Up to 16 weeks)
    Title
    Number of Participants Discontinuing Study Drug Due to an AE Within 48 Hours Post-dose
    Description
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
    Time Frame
    Up to 48 hours post-dose (Up to 14 weeks)
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants With Pain Relief at 2 Hours Post-dose (Period 1, Migraine Attack 1)
    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 (Up to 6 weeks)
    Title
    Number of Participants With a Confirmed Vascular Event Within 48 Hours Post-dose
    Description
    Confirmed Vascular Event included cardiac events, cerebrovascular events, and peripheral vascular events.
    Time Frame
    Up to 48 hours after the dose of any study medication (Up to 14 weeks)
    Title
    Percentage of Participants With Absence of Phonophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)
    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 (Up to 6 weeks)
    Title
    Percentage of Participants With Absence of Photophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)
    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 (Up to 6 weeks)
    Title
    Percentage of Participants With Absence of Nausea at 2 Hours Post-dose (Period 1, Migraine Attack 1)
    Description
    The participant recorded whether nausea was present or absent at each of the predefined time points.
    Time Frame
    2 hours post-dose (Up to 6 weeks)
    Title
    Percentage of Participants With Sustained Pain Freedom (SPF) at 2 to 24 Hours Post-dose
    Description
    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
    Up to 24 hours post-dose (Up to 14 weeks)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Stable coronary artery disease for 3 months or more 18 years of age or older with a history of migraine with or without aura Must use acceptable contraception throughout the study Exclusion Criteria: Pregnant, breast-feeding, or planning to become pregnant during this study 50 years of age or older when migraines began Other pain syndromes that might interfere with study assessments, uncontrolled psychiatric conditions, dementia, or significant neurological disorders (other than migraine) History of gastric, or small intestinal surgery, or has a disease that causes malabsorption

    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
    22221076
    Citation
    Ho TW, Ho AP, Chaitman BR, Johnson C, Mathew NT, Kost J, Fan X, Aurora SK, Brandes JL, Fei K, Beebe L, Lines C, Krucoff MW. Randomized, controlled study of telcagepant in patients with migraine and coronary artery disease. Headache. 2012 Feb;52(2):224-35. doi: 10.1111/j.1526-4610.2011.02052.x. Epub 2012 Jan 6.
    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=0974-034&kw=0974-034&tab=access

    Learn more about this trial

    Telcagepant (MK-0974) Treatment of Migraine in Participants With Stable Vascular Disease (MK-0974-034)

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