Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine

Phase 3

Completed

Conditions: Migraine, With or Without Aura

Interventions: Drug: Ubrogepant
Drug: Placebo-matching Ubrogepant

Registration Number: NCT02867709

Lead Sponsor: Allergan

Brief Summary: This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (25 and 50 mg) compared to placebo for the acute treatment of a single migraine attack.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1686

Inclusion Criteria

At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd edition, beta version
Migraine onset before age 50
History of migraines typically lasting between 4 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom
History of 2 to 8 migraine attacks per month with moderate to severe headache pain in each of the previous 3 months.

Exclusion Criteria

Difficulty distinguishing migraine headache from tension-type other headaches
Has taken medication for acute treatment of headache (including acetaminophen, nonsteroidal anti-inflammatory drugs [NSAIDs], triptans, ergotamine, opioids, or combination analgesics) on 10 or more days per month in the previous 3 months
Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine
Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
Required hospital treatment of a migraine attack 3 or more times in the previous 6 months
Has a chronic non-headache pain condition requiring daily pain medication
Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
Has a history of any prior gastrointestinal conditions (eg, diarrhoea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of investigational product; participants with prior gastric bariatric interventions which have been reversed are not excluded
Has a history of hepatitis within previous 6 months.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ubrogepant 50 mg	Placebo-matching Ubrogepant	1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Placebo	Placebo-matching Ubrogepant	1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Ubrogepant 25 mg	Placebo-matching Ubrogepant	1 ubrogepant 25 milligram (mg) tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Ubrogepant 25 mg	Ubrogepant	1 ubrogepant 25 milligram (mg) tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Ubrogepant 50 mg	Ubrogepant	1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Pain Freedom at 2 Hours After Initial Dose	Baseline (Predose) to 2 hours after initial dose	Pain freedom was defined as a reduction in headache pain severity from moderate/severe at baseline to no pain at 2 hours after the initial dose of investigational product. Participants were provided with 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.
Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose	Baseline (Predose) to 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 assessed.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Pain Relief at 2 Hours After the Initial Dose	Baseline (Predose) to 2 hours after 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.
Percentage of Participants With Absence of Nausea at 2 Hours After the Initial Dose	2 hours after 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.
Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours After Initial Dose	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 assessment of determinable sustained pain relief from 2 to 24 hours after initial dose.
Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose	2 hours after 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.
Percentage of Participants With the Absence of Phonophobia at 2 Hours After the Initial Dose	2 hours after 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.
Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose	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 assessment of determinable sustained pain freedom from 2 to 24 hours after initial dose.

Trial Locations

Locations (105): Cedars Sinai Pain Center
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Los Angeles, California, United States
Rapid Medical Research, Inc.
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Cleveland, Ohio, United States
The Cleveland Clinic Foundation
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Cleveland, Ohio, United States
Preferred Primary Care Physicians, Inc.
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Pittsburgh, Pennsylvania, United States
California Advanced Neurotherapeutic, Inc.
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Los Angeles, California, United States
Princeton Medical Institute
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Princeton, New Jersey, United States
Artemis Institute For Clinical Research
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San Diego, California, United States
LCC Medical Research Institute, LLC
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Miami, Florida, United States
Well Pharma Medical Research, Corp.
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Miami, Florida, United States
Josephson Wallack Munshower Neurology P.C.
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Indianapolis, Indiana, United States
Hope Research Institute
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Las Vegas, Nevada, United States
Sentral Clinical Research Services
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Cincinnati, Ohio, United States
Patient Priority Clinical Sites, LLC
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Cincinnati, Ohio, United States
University of Cincinnati Dept of Psychiatry & Behavioral Neuroscience
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Cincinnati, Ohio, United States
CTI Clinical Research Center
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Cincinnati, Ohio, United States
Summit Research Network Seattle, LLC
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Seattle, Washington, United States
St. Joseph's Hospital & Medical Center - Barrow Neurologic Institute (BNI)
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Phoenix, Arizona, United States
Clinical Research Advantage, Inc./Central Phoenix Medical Clinic, LLC
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Phoenix, Arizona, United States
Carolina Headache Institute
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Durham, North Carolina, United States
Clinical Research Advantage, Inc./Simon Williamson Clinic
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Birmingham, Alabama, United States
Dartmouth-Hitchcock Medical Center
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Lebanon, New Hampshire, United States
West Virginia University, Department of Neurology
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Morgantown, West Virginia, United States
Clinical Research Advantage, Inc./East Valley Family Physicians, PLC
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Chandler, Arizona, United States
Advanced Clinical Research
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Meridian, Idaho, United States
Princeton Center for Clinical Research
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Skillman, New Jersey, United States
Mayo Clinic Arizona, May Clinic Scottsdale
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Scottsdale, Arizona, United States
Radiant Research, Inc.
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Anderson, South Carolina, United States
Bio Behavioral Health
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Toms River, New Jersey, United States
Georgetown University Hospital
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Washington, District of Columbia, United States
Radiant Research Inc.
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Tucson, Arizona, United States
Hillcrest Clinical Research, LLC
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Simpsonville, South Carolina, United States
Middle Tennessee Clinical Research
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Fayetteville, Tennessee, United States
Radiant Clinical Research
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Washington, District of Columbia, United States
Clinical Research Advantage, Inc./Prairie Fields Family Medicine, PC
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Fremont, Nebraska, United States
Clinical Research Advantage, Inc
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Omaha, Nebraska, United States
Meridian Clinical Research, LLC
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Omaha, Nebraska, United States
Medical College of Wisconsin, Department of Neurology
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Milwaukee, Wisconsin, United States
Axiom Research, LLC
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Colton, California, United States
Anaheim Clinical Trials, LLC
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Anaheim, California, United States
Hope Clinical Research
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Canoga Park, California, United States
Pharmacology Research Institute
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Newport Beach, California, United States
Neuro-Pain Medical Center
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Fresno, California, United States
Sun Valley Research Center
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Imperial, California, United States
Grossmont Center For Clinical Research
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La Mesa, California, United States
Rancho Cucamonga Clinical Research
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Rancho Cucamonga, California, United States
George J Rederich MD, Inc
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Redondo Beach, California, United States
Clinical Research Advantage, Inc./Cassidy Medical Group-Vista
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Vista, California, United States
Colorado Neurological Institute
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Englewood, Colorado, United States
Advanced Neurosciences Research, LLC
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Fort Collins, Colorado, United States
Aventura Neurological Associates
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Aventura, Florida, United States
Clinical Research South Florida
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Coral Gables, Florida, United States
Broward Research Group
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Hollywood, Florida, United States
Avail Clinical Research, LLC
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DeLand, Florida, United States
Neurology Associates, P.A.
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Maitland, Florida, United States
Health Awareness, Inc.
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Jupiter, Florida, United States
Panax Clinical Research
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Miami Lakes, Florida, United States
Renstar Medical Research
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Ocala, Florida, United States
Sensible Healthcare, LLC
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Ocoee, Florida, United States
Suncoast Clinical Research
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New Port Richey, Florida, United States
QPS MRA, LLC (Miami Research Associates)
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South Miami, Florida, United States
The Kaufmann Clinic, Inc.
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Atlanta, Georgia, United States
Palm Beach Research Center
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West Palm Beach, Florida, United States
NeuroTrials Research, Inc.
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Atlanta, Georgia, United States
Clinical Research Advantage, Inc./Michigan Avenue Internists
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Chicago, Illinois, United States
Cedar Crosse Research Center
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Chicago, Illinois, United States
Robbins Headache Clinic
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Riverwoods, Illinois, United States
Seton Medical Group
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Baltimore, Maryland, United States
Beacon Clinical Research, LLC
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Quincy, Massachusetts, United States
Overlea Personal Physicians
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Baltimore, Maryland, United States
BTC of New Bedford
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New Bedford, Massachusetts, United States
New England Regional Headache Center, Inc.
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Worcester, Massachusetts, United States
Quest Research Institute
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Farmington Hills, Michigan, United States
The Headache Center
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Ridgeland, Mississippi, United States
Minneapolis Clinic of Neurology
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Golden Valley, Minnesota, United States
DENT Neurosciences Research Center
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Amherst, New York, United States
Cushing Neuroscience Institute North Shore-LIJ Medical Group
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Great Neck, New York, United States
ProHealth Care Associates, LLP
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Plainview, New York, United States
Upstate Clinical Research Associates, LLC
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Williamsville, New York, United States
Westchester Neuro. Const
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Yonkers, New York, United States
Lake Shore Clinical Research, LLC
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Mooresville, North Carolina, United States
Plains Clinical Research Center, LLC
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Fargo, North Dakota, United States
Sooner Clinical Research
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Oklahoma City, Oklahoma, United States
Preferred Primary Care Physicians
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Uniontown, Pennsylvania, United States
Abington Neurological Associates, Ltd.
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Willow Grove, Pennsylvania, United States
Volunteer Research Group
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Knoxville, Tennessee, United States
Texas Neurology, P.A.
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Dallas, Texas, United States
Advanced Research Institute
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Ogden, Utah, United States
Vista Clinical Research
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Columbia, South Carolina, United States
Radiant Research, Inc
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Dallas, Texas, United States
Baptist Memorial Medical Group (Neurology Specialist - Headache Clinic)
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Memphis, Tennessee, United States
Research Trials Worldwide, LLC
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Humble, Texas, United States
Clinical Research Associates of Tidewater
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Norfolk, Virginia, United States
iNeuro Headache Specialist
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McLean, Virginia, United States
Charlottesville Medical Research Center, LLC
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Charlottesville, Virginia, United States
Blue Ridge Research Center, LLC
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Roanoke, Virginia, United States
Sentara Neurology Specialists
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Virginia Beach, Virginia, United States
South Puget Sound Neurology
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Tacoma, Washington, United States
Norton Neurology Services MS Services
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Louisville, Kentucky, United States
L-MARC Research Center
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Louisville, Kentucky, United States
Clinicos, LLC
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Colorado Springs, Colorado, United States
Headache Wellness Center, PC
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Greensboro, North Carolina, United States
California Headache and Balance Center
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Fresno, California, United States
Desert Valley Research
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Rancho Mirage, California, United States
Raleigh Neurology Associates, PA
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Raleigh, North Carolina, United States
Clinical Trials of South Carolina
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Charleston, South Carolina, United States