Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
518
For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours
For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours
Percentage of Participants Reporting Absence of Headache of Moderate/Severe Intensity Within 24 Hours Post-dose
The absence of a headache of moderate/severe intensity will be recorded by the participant in an electronic diary (eDiary) within 24 hours after taking double-blind study intervention during the prodrome in order to determine the attenuation of headache. The absence of moderate or severe headache are derived based on headache record and rescue use.
Time frame: 24 hours after taking double-blind study intervention during the prodrome
Percentage of Participants Reporting Absence of Headache of Moderate or Severe Intensity Within 48 Hours Post-dose
The absence of a headache of moderate or severe intensity will be recorded by the participant in an eDiary within 48 hours after taking double-blind study intervention during the prodrome in order to determine the prevention of headache
Time frame: 48 hours after taking double-blind study intervention during the prodrome
Percentage of Participants Reporting Improvement in the Ability to Function Normally Over 24 Hours Post-dose
The Functional Disability Scale (FDS) is a single item used to measure the participant's level to function normally. Participants will be asked to rate the performance of daily activities using 4 response options ranging from 0 (no disability, able to function normally) to 3 (severely impaired, cannot do all or most things, bed rest may be necessary) within 24 hours after taking double-blind study intervention during the prodrome
Time frame: 24 hours after taking double-blind study intervention during the prodrome
Percentage of Participants Reporting Absence of Headache of Any Intensity Within 24 Hours Post-dose
The absence of a headache of moderate/severe intensity will be recorded by the participant in an electronic diary (eDiary) within 24 hours after taking double-blind study intervention during the prodrome in order to determine the attenuation of headache. The absence of moderate or severe headache are derived based on headache record and rescue use.
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Achieve Clinical Research, LLC /ID# 237098
Birmingham, Alabama, United States
Barrow Neuro Institute /ID# 236775
Phoenix, Arizona, United States
Arkansas Clinical Research /ID# 238032
Little Rock, Arkansas, United States
California Headache and Balance Center /ID# 236247
Fresno, California, United States
Sun Valley Research Center /ID# 236561
Imperial, California, United States
Wr-Pri Llc /Id# 236007
Los Alamitos, California, United States
Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 237691
Newport Beach, California, United States
Excell Research, Inc /ID# 237721
Oceanside, California, United States
George J. Rederich M.D. Inc. /ID# 235769
Torrance, California, United States
Diablo Clinical Research /ID# 237570
Walnut Creek, California, United States
...and 63 more locations
Time frame: 24 hours after taking double-blind study intervention during the prodrome