A Study to Test the Safety and Effectiveness of MK-0974 (Telcagepant) Co-administered With Ibuprofen or Acetaminophen in Patients With Migraines With or Without Aura (MK-0974-046)

Study Overview
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Brief Summary
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This study will test the safety and how effective telcagepant is when taken with ibuprofen or acetaminophen in participants with migraine with or without aura. The primary study hypothesis is that at least one drug combination is superior to telecagepant alone in the treatment of acute migraines.

Official Title
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A Phase IIa Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled, Clinical Trial to Study the Efficacy and Safety of MK0974 Co-administered With Ibuprofen or Acetaminophen in Patients With Migraine With or Without Aura

Conditions
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Migraine

Intervention / Treatment
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* Drug: placebo
* Drug: ibuprofen
* Drug: acetominophen
* Drug: telcagepant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be 18 years of age or older History of migraine with or without aura for more than 1 year with 1-8 moderate or severe migraine attacks per month in the 2 months prior to starting in the study Willing to stay awake for at least 2 hours after taking study drug Able to read, understand and complete questionnaires and diaries Exclusion Criteria: Breast-feeding, pregnant, or plan to become pregnant during the study Not able to tell migraine attack from other headaches Older than 50 years of age at migraine onset Have more than 15 headache days per month or have taken medication for acute headache on more than 10 days per month in any of the 3 months before starting in the study History of gastric or small intestinal surgery History of heart attack, stroke, unstable angina, coronary artery bypass surgery or transient ischemic attack in the 3 months before starting in the study Currently participating or have participated in a study with in investigational compound or device in the last 30 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine | Drug: placebo<br> <br> |
| Experimental: Telcagepant 280 mg +Ibuprofen 400 mg<br>Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine | Drug: ibuprofen<br> <br> Drug: telcagepant<br> <br> * Other names: MK-0974;|
| Experimental: Telcagepant 280 mg +APAP 1000 mg<br>Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine | Drug: acetominophen<br> <br> * Other names: N-acetyl-p-aminophenol (APAP);Drug: telcagepant<br> <br> * Other names: MK-0974;|
| Placebo Comparator: Telcagepant 280 mg<br>Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine | Drug: telcagepant<br> <br> * Other names: MK-0974;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Pain Freedom at Two Hours Post-dose | Pain severity was rated by the participants in a paper diary by grade; Grade 0 (no pain), Grade 1 (mild pain), Grade 2 (moderate pain), and Grade 3 (severe pain). Pain freedom was defined as a reduction in pain severity from moderate to severe migraine headache (Grade 2 or 3) to no pain (Grade 0). | 2 hours post-dose | 
| Number of Participants Experiencing Adverse Events Within 48 Hours Post-dose (Count ≥4 in One or More Treatment Groups) | An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. | Up to 48 hours post-dose | 
| Number of Participants Experiencing Adverse Events Within 14 Days Post-dose (Count ≥4 in One or More Treatment Groups) | An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. | Up to 14 days post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Pain Relief at 2 Hours Post-dose. | Pain severity was rated by the participants in a paper diary by grade; Grade 0 (no pain), Grade 1 (mild pain), Grade 2 (moderate pain), and Grade 3 (severe pain). Pain relief was defined as a reduction in pain severity from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0). | 2 hours post-dose |