This study is being conducted to evaluate the efficacy and tolerability of rimegepant in a population of adults that are unsuitable for triptan medications due to a previous intolerance, lack of efficacy, or contraindication (including a history of clinically-relevant cardiovascular disease).
This study is being conducted to evaluate the efficacy and tolerability of rimegepant in a population of adults that are unsuitable for triptan medications due to a previous intolerance, lack of efficacy, or contraindication (including a history of clinically-relevant cardiovascular disease). Rimegepant will be further evaluated in this population with as needed use in a 12-week, open-label extension study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
632
DB Phase: Rimegepant 75 mg Orally Disintegrating Tablet (ODT)
DB Phase: matching placebo
OLE Phase: Rimegepant 75 mg ODT in association with each of the first 5 qualifying migraines
Compare the efficacy of rimegepant with placebo in the acute treatment of migraine, as measured by migraine headache pain relief at 2-hours post-dose during the Double-Blind Treatment (DBT) Phase.
Migraine headache pain relief will be assessed using the percentage of subjects with a headache pain intensity of none or mild. Migraine headache pain intensity will be measured on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe).
Time frame: 2 hours post-dose
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Clinical Research Institute
Los Angeles, California, United States
Ki Health Partners LLC, dba New England Institute for Clinical Research
Stamford, Connecticut, United States
Wr-Msra, Llc
Lake City, Florida, United States
Sensible Healthcare LLC
Ocoee, Florida, United States
Sandhill Research, LLC d/b/a Accel Research Sites Network - Ormond Clinical Research Unit
Ormond Beach, Florida, United States
WR-Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, United States
Collective Medical Research
Overland Park, Kansas, United States
DelRicht Research
New Orleans, Louisiana, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Community Clinical Research Network Inc
Marlborough, Massachusetts, United States
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