The purpose of this study is to investigate the safety and tolerability of telcagepant (MK-0974) in the long-term treatment of acute migraine in adult participants. The primary hypothesis of this study is that telcagepant is well tolerated in the long-term treatment of acute migraine in adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,068
One capsule taken orally at onset of migraine
One tablet taken orally at onset of migraine
One tablet taken orally at onset of migraine
Percentage of Participants With At Least One Triptan-Related Adverse Experience (AE)
Triptan-related AEs are defined as: chest pain, chest tightness, asthenia, paraesthesia, dysaesthesia or hyperaesthesia. Participants were monitored for triptan-related AEs for 14 days after any dose of study drug.
Time frame: Within 14 days of any dose of study drug (Up to 18.5 months)
Percentage of Participants With At Least One Clinical 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 product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination. Participants were monitored for clinical AEs for 14 days after any dose of study drug.
Time frame: Within 14 days of any dose of study drug (Up to 18.5 months)
Percentage of Participants With At Least One Laboratory 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 product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. Participants were monitored for laboratory AEs for 14 days after any dose of study drug.
Time frame: Within 14 days of any dose of study drug (Up to 18.5 months)
Percentage of Participants With At Least One Vital Sign Measurement Outside Predefined Limits of Change
Predefined limits of change were established for vital sign measurements: Systolic Blood Pressure (\>=180 mm Hg and 20 mm Hg increase OR \<=90 mm Hg and 20 mm Hg decrease), Diastolic Blood Pressure (\>=105 mm Hg and 15 mm Hg increase OR \<=50 mm Hg and 15 mm Hg decrease), Pulse (\>=120 beats per minute \[bpm\] and 15 bpm increase OR \<=50 bpm and 15 bpm decrease), Body Temperature (\>38º C \[oral equivalent\]) and Respiratory Rate (\>25 or increase of 10 OR \<5 or decrease of 10 \[per minute\]). Participants were monitored for vital sign measurements outside predefined limits of change for 14 days after any dose of study drug.
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One capsule taken orally at onset of migraine
One tablet taken orally at onset of migraine
One tablet taken orally at onset of migraine
Time frame: Within 14 days of any dose of study drug (Up to 18.5 months)
Percentage of Participant Migraine Attacks 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 mild, moderate or severe migraine headache (Grade 1, 2, or 3) at baseline to no pain (Grade 0) 2 hours post-dose.
Time frame: 2 hours post-dose (Up to 18 months)