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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,380
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.
Number of Participants With Pain Freedom (PF) at 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.
Time frame: 2 hours post-dose
Number of Participants With Pain Relief (PR) at 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.
Time frame: 2 hours post-dose
Number of Participants With Absence of Photophobia at 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.
Time frame: 2 hours post-dose
Number of Participants With Absence of Phonophobia at 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.
Time frame: 2 hours post-dose
Number of Participants With Absence of Nausea at 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.
Time frame: 2 hours post-dose
Number of Participants Who Experience At Least One Adverse Event (AE)
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.
Time frame: Up to 14 days after last dose of study drug
Number of Participants Who Discontinue Study Drug Due to an AE
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.
Time frame: Up to 48 hours after first dose of study drug
Number of Participants With Sustained Pain Freedom (SPF) From 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.
Time frame: 2 to 24 hours post-dose
Number of Participants With Total Migraine Freedom (TMF) at 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.
Time frame: 2 hours post-dose
Number of Participants With Total Migraine Freedom (TMF) at 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.
Time frame: 2 to 24 hours post-dose
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