Study of Telcagepant (MK-0974) in Participants With Moderate to Severe Acute Migraine With or Without Aura (MK-0974-011)
Condition: Migraine
MeSH terms: Migraine Disorders
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
Intervention description: Telcagepant 150 mg liquid-filled soft gel capsules; Telcagepant 300 mg liquid-filled soft gel capsules; Zolmitriptan 5 mg tablets; Placebo to match telcagepant 150 mg liquid-filled soft gel capsules; Placebo to match tecagepant 300 mg liquid-filled soft gel capsules; Placebo to match zolmitriptan 5 mg tablets; 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.
Intervention MeSH terms: Oxazolidinones; Zolmitriptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1380.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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.