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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00442936
First received: February 28, 2007
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Migraine
Drug: Telcagepant potassium 150 mg
Drug: Telcagepant potassium 300 mg
Drug: Zolmitriptan 5 mg
Drug: Placebo to telcagepant 150 mg
Drug: Placebo to tecagepant 300 mg
Drug: Placebo to zolmitriptan 5 mg
Drug: Rescue medication
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants With Pain Freedom (PF) at 2 Hours Post-Dose [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]
    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) [ Time Frame: Up to 14 days after last dose of study drug ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to 48 hours after first dose of study drug ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 2 to 24 hours post-dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 to 24 hours post-dose ] [ Designated as safety issue: No ]
    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.


Enrollment: 1380
Study Start Date: February 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telcagepant 150 mg
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.
Drug: Telcagepant potassium 150 mg
Telcagepant 150 mg liquid-filled soft gel capsules
Drug: Placebo to tecagepant 300 mg
Placebo to match tecagepant 300 mg liquid-filled soft gel capsules
Drug: Placebo to zolmitriptan 5 mg
Placebo to match zolmitriptan 5 mg tablets
Drug: Rescue medication
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.
Experimental: Telcagepant 300 mg
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.
Drug: Telcagepant potassium 300 mg
Telcagepant 300 mg liquid-filled soft gel capsules
Drug: Placebo to telcagepant 150 mg
Placebo to match telcagepant 150 mg liquid-filled soft gel capsules
Drug: Placebo to zolmitriptan 5 mg
Placebo to match zolmitriptan 5 mg tablets
Drug: Rescue medication
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.
Active Comparator: Zolmitriptan 5 mg
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.
Drug: Zolmitriptan 5 mg
Zolmitriptan 5 mg tablets
Drug: Placebo to telcagepant 150 mg
Placebo to match telcagepant 150 mg liquid-filled soft gel capsules
Drug: Placebo to tecagepant 300 mg
Placebo to match tecagepant 300 mg liquid-filled soft gel capsules
Drug: Rescue medication
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.
Placebo Comparator: Placebo
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.
Drug: Placebo to telcagepant 150 mg
Placebo to match telcagepant 150 mg liquid-filled soft gel capsules
Drug: Placebo to tecagepant 300 mg
Placebo to match tecagepant 300 mg liquid-filled soft gel capsules
Drug: Placebo to zolmitriptan 5 mg
Placebo to match zolmitriptan 5 mg tablets
Drug: Rescue medication
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442936

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00442936     History of Changes
Other Study ID Numbers: 0974-011, MK-0974-011, 2006_525
Study First Received: February 28, 2007
Results First Received: June 17, 2014
Last Updated: July 31, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Oxazolidinones
Zolmitriptan
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014