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Completed

NCT Number: NCT00662818

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

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.

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Key information

Conditions

Migraine Disorders Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Accident Cerebrovascular Disorders Headache Disorders Headache Disorders, Primary Heart Disease Heart Diseases Ischemic Attack, Transient Nervous System Diseases Peripheral Vascular Diseases Stroke TIA (Transient Ischemic Attack) Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

telcagepant

Drug

Telcagepant (MK-0974) (300 mg soft gel capsules or 280 mg tablets)

Acetaminophen/paracetamol

Drug

Acetaminophen/Paracetamol (500 mg X 2 dosage units)

Placebo to telcagepant

Drug

Placebo 300 mg soft gel capsules or placebo 280 mg tablet.

Placebo to Acetaminophen/Paracetamol

Drug

Placebo to acetaminophen/paracetamol (500 mg X 2 dosage units)

Primary outcomes

  1. Percentage of Participants With Pain Freedom at 2 Hours Post-dose (Period 1, Migraine Attack 1)

    Time frame: 2 hours post-dose (Up to 6 weeks)

    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.

  2. Number of Participants Who Experienced an Adverse Event (AE) Within 14 Days Post-dose

    Time frame: Within 14 days of any dose of study medication (Up to 16 weeks)

    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.

  3. Number of Participants Discontinuing Study Drug Due to an AE Within 48 Hours Post-dose

    Time frame: Up to 48 hours post-dose (Up to 14 weeks)

    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 outcomes

  1. Percentage of Participants With Pain Relief at 2 Hours Post-dose (Period 1, Migraine Attack 1)

    Time frame: 2 hours post-dose (Up to 6 weeks)

    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.

  2. Number of Participants With a Confirmed Vascular Event Within 48 Hours Post-dose

    Time frame: Up to 48 hours after the dose of any study medication (Up to 14 weeks)

    Confirmed Vascular Event included cardiac events, cerebrovascular events, and peripheral vascular events.

  3. Percentage of Participants With Absence of Phonophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)

    Time frame: 2 hours post-dose (Up to 6 weeks)

    The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points.

  4. Percentage of Participants With Absence of Photophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)

    Time frame: 2 Hours post-dose (Up to 6 weeks)

    The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points.

  5. Percentage of Participants With Absence of Nausea at 2 Hours Post-dose (Period 1, Migraine Attack 1)

    Time frame: 2 hours post-dose (Up to 6 weeks)

    The participant recorded whether nausea was present or absent at each of the predefined time points.

  6. Percentage of Participants With Sustained Pain Freedom (SPF) at 2 to 24 Hours Post-dose

    Time frame: Up to 24 hours post-dose (Up to 14 weeks)

    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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 21, 2008
Registry last updated
Oct 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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