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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
165
Telcagepant (MK-0974) (300 mg soft gel capsules or 280 mg tablets)
Acetaminophen/Paracetamol (500 mg X 2 dosage units)
Placebo 300 mg soft gel capsules or placebo 280 mg tablet.
Placebo to acetaminophen/paracetamol (500 mg X 2 dosage units)
Percentage of Participants With Pain Freedom at 2 Hours Post-dose (Period 1, Migraine Attack 1)
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.
Time frame: 2 hours post-dose (Up to 6 weeks)
Number of Participants Who Experienced an Adverse Event (AE) Within 14 Days Post-dose
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.
Time frame: Within 14 days of any dose of study medication (Up to 16 weeks)
Number of Participants Discontinuing Study Drug Due to an AE Within 48 Hours Post-dose
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.
Time frame: Up to 48 hours post-dose (Up to 14 weeks)
Percentage of Participants With Pain Relief at 2 Hours Post-dose (Period 1, Migraine Attack 1)
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.
Time frame: 2 hours post-dose (Up to 6 weeks)
Number of Participants With a Confirmed Vascular Event Within 48 Hours Post-dose
Confirmed Vascular Event included cardiac events, cerebrovascular events, and peripheral vascular events.
Time frame: Up to 48 hours after the dose of any study medication (Up to 14 weeks)
Percentage of Participants With Absence of Phonophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)
The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points.
Time frame: 2 hours post-dose (Up to 6 weeks)
Percentage of Participants With Absence of Photophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)
The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points.
Time frame: 2 Hours post-dose (Up to 6 weeks)
Percentage of Participants With Absence of Nausea at 2 Hours Post-dose (Period 1, Migraine Attack 1)
The participant recorded whether nausea was present or absent at each of the predefined time points.
Time frame: 2 hours post-dose (Up to 6 weeks)
Percentage of Participants With Sustained Pain Freedom (SPF) at 2 to 24 Hours Post-dose
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.
Time frame: Up to 24 hours post-dose (Up to 14 weeks)
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