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Completed

NCT Number: NCT00442936

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

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System 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

  • 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.

Treatment and study plan

Telcagepant potassium 150 mg

Drug

Telcagepant 150 mg liquid-filled soft gel capsules

Telcagepant potassium 300 mg

Drug

Telcagepant 300 mg liquid-filled soft gel capsules

Zolmitriptan 5 mg

Drug

Zolmitriptan 5 mg tablets

Placebo to telcagepant 150 mg

Drug

Placebo to match telcagepant 150 mg liquid-filled soft gel capsules

Placebo to tecagepant 300 mg

Drug

Placebo to match tecagepant 300 mg liquid-filled soft gel capsules

Placebo to zolmitriptan 5 mg

Drug

Placebo to match zolmitriptan 5 mg tablets

Rescue medication

Drug

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 outcomes

  1. Number of Participants With Pain Freedom (PF) at 2 Hours Post-Dose

    Time frame: 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.

  2. Number of Participants With Pain Relief (PR) at 2 Hours Post-Dose

    Time frame: 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.

  3. Number of Participants With Absence of Photophobia at 2 Hours Post-Dose

    Time frame: 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.

  4. Number of Participants With Absence of Phonophobia at 2 Hours Post-Dose

    Time frame: 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.

  5. Number of Participants With Absence of Nausea at 2 Hours Post-Dose

    Time frame: 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.

  6. Number of Participants Who Experience At Least One Adverse Event (AE)

    Time frame: Up to 14 days after last dose of study drug

    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.

  7. Number of Participants Who Discontinue Study Drug Due to an AE

    Time frame: Up to 48 hours after first dose of study drug

    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 outcomes

  1. Number of Participants With Sustained Pain Freedom (SPF) From 2 to 24 Hours Post-Dose

    Time frame: 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.

  2. Number of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose

    Time frame: 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.

  3. Number of Participants With Total Migraine Freedom (TMF) at 2 to 24 Hours Post-Dose

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Mar 5, 2007
Registry last updated
Oct 17, 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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