This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (50 and 100 mg) compared to placebo for the acute treatment of a single migraine attack.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,672
50 mg ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
Percentage of Participants With Pain Freedom at 2 Hours After Initial Dose
Pain freedom was defined as a reduction in headache severity from moderate/severe at baseline to no pain at 2 hours after the initial dose. Participants were provided with an electronic diary (eDiary) to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing postdose pain severity assessment at or before 2 hours after initial dose.
Time frame: Baseline (Predose) to 2 hours after initial dose
Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose
The most bothersome migraine-associated symptom was the symptom (photophobia, phonophobia or nausea) present at pre-dose baseline identified by the participant to be 'most bothersome'. Participants were provided with an eDiary to record absence or presence of migraine-associated symptoms. Number analyzed is the number of participants with non-missing postdose most bothersome migraine-associated symptoms.
Time frame: Baseline (Predose) to 2 hours after initial dose
Percentage of Participants With Pain Relief at 2 Hours After the Initial Dose
Pain relief was defined as a reduction of a moderate/severe migraine headache to a mild headache or to no headache. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing pain severity assessment at or before 2 hours after initial dose.
Time frame: Baseline (Predose) to 2 hours after initial dose
Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours After Initial Dose
Sustained pain relief was defined as a pain relief at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a moderate/severe headache up to 24 hours after dosing with study drug. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Determinable cases: participants for whom sustained pain relief from 2 to 24 hours status can be determined based on the observed headache severity at scheduled time points, use of rescue medication or optional second dose between 2 and 24 hours, and the answer to the headache recurrence question at 24 hours. Number analyzed is the number of participants with determinable sustained pain relief from 2 to 24 hours after initial dose.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clinical Research Advantage, Inc./Desert Clinical Research, LLC.
Mesa, Arizona, United States
Xenoscience, Inc.
Phoenix, Arizona, United States
Clinical Research Advantage, Inc./Orange Grove Family Practice
Tucson, Arizona, United States
Principals Research Group, Inc.
Hot Springs, Arkansas, United States
KLR Business Group, Inc. dba Arkansas Clinical Research
Little Rock, Arkansas, United States
The Research Center of Southern California, LLC
Carlsbad, California, United States
Med Center
Carmichael, California, United States
T. Joseph Raoof MD, Inc./Encino Research Center
Encino, California, United States
Neurology Center of North Orange County
Fullerton, California, United States
Behavioral Research Specialists, LLC
Glendale, California, United States
...and 80 more locations
Time frame: 2 to 24 hours after initial dose
Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose
Sustained pain freedom was defined as a pain freedom at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a mild/moderate/severe headache up to 24 hours after dosing with study drug. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Determinable cases: participants for whom sustained pain relief from 2 to 24 hours status can be determined based on the observed headache severity at scheduled time points, use of rescue medication or optional second dose between 2 and 24 hours, and the answer to the headache recurrence question at 24 hours. Number analyzed is the number of participants with determinable sustained pain freedom from 2 to 24 hours after initial dose.
Time frame: 2 to 24 hours after initial dose
Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose
Photophobia was defined as sensitivity to light, a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence photophobia. Number analyzed is the number of participants with non-missing postdose photophobia assessment at or before 2 hours after initial dose.
Time frame: 2 hours after initial dose
Percentage of Participants With the Absence of Phonophobia at 2 Hours After the Initial Dose
Phonophobia was defined as sensitivity to sound, a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence of phonophobia. Number analyzed is the number of participants with non-missing postdose phonophobia assessment at or before 2 hours after initial dose.
Time frame: 2 hours after initial dose
Percentage of Participants With Absence of Nausea at 2 Hours After the Initial Dose
Nausea was a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence of nausea. Number analyzed is the number of participants with non-missing postdose nausea assessment at or before 2 hours after initial dose.
Time frame: 2 hours after initial dose