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Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine (ACHIEVE II)

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ClinicalTrials.gov Identifier: NCT02867709
Recruitment Status : Completed
First Posted : August 16, 2016
Results First Posted : January 29, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Migraine, With or Without Aura Drug: Ubrogepant Drug: Placebo-matching Ubrogepant Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1686 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Single Attack Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine
Actual Study Start Date : August 26, 2016
Actual Primary Completion Date : January 25, 2018
Actual Study Completion Date : February 26, 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine
Drug Information available for: Ubrogepant

Arm Intervention/treatment
Experimental: Ubrogepant 25 mg
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.
Drug: Ubrogepant
Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.

Drug: Placebo-matching Ubrogepant
Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.

Experimental: Ubrogepant 50 mg
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.
Drug: Ubrogepant
Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.

Drug: Placebo-matching Ubrogepant
Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.

Placebo Comparator: Placebo
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.
Drug: Placebo-matching Ubrogepant
Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.




Primary Outcome Measures :
  1. Percentage of Participants With Pain Freedom at 2 Hours After Initial Dose [ Time Frame: 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.

  2. Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose [ Time Frame: 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 :
  1. Percentage of Participants With Pain Relief at 2 Hours After the Initial Dose [ Time Frame: 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.

  2. Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours After Initial Dose [ Time Frame: 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.

  3. Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose [ Time Frame: 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.

  4. Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose [ Time Frame: 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.

  5. Percentage of Participants With the Absence of Phonophobia at 2 Hours After the Initial Dose [ Time Frame: 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.

  6. Percentage of Participants With Absence of Nausea at 2 Hours After the Initial Dose [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867709


Locations
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United States, Alabama
Clinical Research Advantage, Inc./Simon Williamson Clinic
Birmingham, Alabama, United States, 35211
United States, Arizona
Clinical Research Advantage, Inc./East Valley Family Physicians, PLC
Chandler, Arizona, United States, 85224
St. Joseph's Hospital & Medical Center - Barrow Neurologic Institute (BNI)
Phoenix, Arizona, United States, 85013
Clinical Research Advantage, Inc./Central Phoenix Medical Clinic, LLC
Phoenix, Arizona, United States, 85020
Mayo Clinic Arizona, May Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
Radiant Research Inc.
Tucson, Arizona, United States, 85712
United States, California
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92801
Axiom Research, LLC
Apple Valley, California, United States, 92307
Hope Clinical Research
Canoga Park, California, United States, 91303
Axiom Research, LLC
Colton, California, United States, 92324
Pharmacology Research Institute
Encino, California, United States, 91316
Neuro-Pain Medical Center
Fresno, California, United States, 93710
California Headache and Balance Center
Fresno, California, United States, 93720
Sun Valley Research Center
Imperial, California, United States, 92251
Grossmont Center For Clinical Research
La Mesa, California, United States, 91942
Pharmacology Research Institute
Los Alamitos, California, United States, 90720
California Advanced Neurotherapeutic, Inc.
Los Angeles, California, United States, 90024
Cedars Sinai Pain Center
Los Angeles, California, United States, 90048
Pharmacology Research Institute
Newport Beach, California, United States, 92660
Rancho Cucamonga Clinical Research
Rancho Cucamonga, California, United States, 91730
Desert Valley Research
Rancho Mirage, California, United States, 92270
George J Rederich MD, Inc
Redondo Beach, California, United States, 90277
Artemis Institute For Clinical Research
San Diego, California, United States, 92103
Clinical Research Advantage, Inc./Cassidy Medical Group-Vista
Vista, California, United States, 92083
United States, Colorado
Clinicos, LLC
Colorado Springs, Colorado, United States, 80904
Colorado Neurological Institute
Englewood, Colorado, United States, 80113
Advanced Neurosciences Research, LLC
Fort Collins, Colorado, United States, 80528
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
Radiant Clinical Research
Washington, District of Columbia, United States, 20016
United States, Florida
Aventura Neurological Associates
Aventura, Florida, United States, 33180
Clinical Research South Florida
Coral Gables, Florida, United States, 33134
Avail Clinical Research, LLC
DeLand, Florida, United States, 32720
Broward Research Group
Hollywood, Florida, United States, 33024
Health Awareness, Inc.
Jupiter, Florida, United States, 33458
Neurology Associates, P.A.
Maitland, Florida, United States, 32751
Panax Clinical Research
Miami Lakes, Florida, United States, 33014
LCC Medical Research Institute, LLC
Miami, Florida, United States, 33126
Well Pharma Medical Research, Corp.
Miami, Florida, United States, 33143
Suncoast Clinical Research
New Port Richey, Florida, United States, 34652
Renstar Medical Research
Ocala, Florida, United States, 34470
Sensible Healthcare, LLC
Ocoee, Florida, United States, 34761
QPS MRA, LLC (Miami Research Associates)
South Miami, Florida, United States, 33143
Palm Beach Research Center
West Palm Beach, Florida, United States, 33409
United States, Georgia
The Kaufmann Clinic, Inc.
Atlanta, Georgia, United States, 30308
NeuroTrials Research, Inc.
Atlanta, Georgia, United States, 30342
United States, Idaho
Advanced Clinical Research
Meridian, Idaho, United States, 83642
United States, Illinois
Clinical Research Advantage, Inc./Michigan Avenue Internists
Chicago, Illinois, United States, 60604
Cedar Crosse Research Center
Chicago, Illinois, United States, 60607
Robbins Headache Clinic
Riverwoods, Illinois, United States, 60015
United States, Indiana
Josephson Wallack Munshower Neurology P.C.
Indianapolis, Indiana, United States, 46256
United States, Kentucky
Norton Neurology Services MS Services
Louisville, Kentucky, United States, 40207
L-MARC Research Center
Louisville, Kentucky, United States, 40213
United States, Maryland
Seton Medical Group
Baltimore, Maryland, United States, 21228
Overlea Personal Physicians
Baltimore, Maryland, United States, 21236
United States, Massachusetts
BTC of New Bedford
New Bedford, Massachusetts, United States, 02740
Beacon Clinical Research, LLC
Quincy, Massachusetts, United States, 02169
New England Regional Headache Center, Inc.
Worcester, Massachusetts, United States, 01605
United States, Michigan
Quest Research Institute
Farmington Hills, Michigan, United States, 48334
United States, Minnesota
Minneapolis Clinic of Neurology
Golden Valley, Minnesota, United States, 55422
United States, Mississippi
The Headache Center
Ridgeland, Mississippi, United States, 39157
United States, Nebraska
Clinical Research Advantage, Inc./Prairie Fields Family Medicine, PC
Fremont, Nebraska, United States, 68025
Clinical Research Advantage, Inc
Omaha, Nebraska, United States, 68114
Meridian Clinical Research, LLC
Omaha, Nebraska, United States, 68134
United States, Nevada
Hope Research Institute
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Princeton Medical Institute
Princeton, New Jersey, United States, 08540
Princeton Center for Clinical Research
Skillman, New Jersey, United States, 08558
Bio Behavioral Health
Toms River, New Jersey, United States, 08755
United States, New York
DENT Neurosciences Research Center
Amherst, New York, United States, 14226
Cushing Neuroscience Institute North Shore-LIJ Medical Group
Great Neck, New York, United States, 11021
ProHealth Care Associates, LLP
Plainview, New York, United States, 11803
Upstate Clinical Research Associates, LLC
Williamsville, New York, United States, 14221
Westchester Neuro. Const
Yonkers, New York, United States, 10701
United States, North Carolina
Carolina Headache Institute
Durham, North Carolina, United States, 27713
Headache Wellness Center, PC
Greensboro, North Carolina, United States, 27405
Lake Shore Clinical Research, LLC
Mooresville, North Carolina, United States, 28117
Raleigh Neurology Associates, PA
Raleigh, North Carolina, United States, 27607
United States, North Dakota
Plains Clinical Research Center, LLC
Fargo, North Dakota, United States, 58104
United States, Ohio
Radiant Research, Inc.
Akron, Ohio, United States, 44311
Sentral Clinical Research Services
Cincinnati, Ohio, United States, 45212
Patient Priority Clinical Sites, LLC
Cincinnati, Ohio, United States, 45215
University of Cincinnati Dept of Psychiatry & Behavioral Neuroscience
Cincinnati, Ohio, United States, 45219
CTI Clinical Research Center
Cincinnati, Ohio, United States, 45227
Rapid Medical Research, Inc.
Cleveland, Ohio, United States, 44122
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Sooner Clinical Research
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Preferred Primary Care Physicians, Inc.
Pittsburgh, Pennsylvania, United States, 15236
Preferred Primary Care Physicians
Uniontown, Pennsylvania, United States, 15401
Abington Neurological Associates, Ltd.
Willow Grove, Pennsylvania, United States, 19090
United States, South Carolina
Radiant Research, Inc.
Anderson, South Carolina, United States, 29621
Clinical Trials of South Carolina
Charleston, South Carolina, United States, 29406
Vista Clinical Research
Columbia, South Carolina, United States, 29201
Hillcrest Clinical Research, LLC
Simpsonville, South Carolina, United States, 29681
United States, Tennessee
Middle Tennessee Clinical Research
Fayetteville, Tennessee, United States, 37334
Volunteer Research Group
Knoxville, Tennessee, United States, 37920
Baptist Memorial Medical Group (Neurology Specialist - Headache Clinic)
Memphis, Tennessee, United States, 38120
United States, Texas
Texas Neurology, P.A.
Dallas, Texas, United States, 75214
Radiant Research, Inc
Dallas, Texas, United States, 75234
Research Trials Worldwide, LLC
Humble, Texas, United States, 77338
United States, Utah
Advanced Research Institute
Ogden, Utah, United States, 84403
United States, Virginia
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, United States, 22911
iNeuro Headache Specialist
McLean, Virginia, United States, 22102
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States, 23507
Blue Ridge Research Center, LLC
Roanoke, Virginia, United States, 24018
Sentara Neurology Specialists
Virginia Beach, Virginia, United States, 23456
United States, Washington
Summit Research Network Seattle, LLC
Seattle, Washington, United States, 98104
South Puget Sound Neurology
Tacoma, Washington, United States, 98409
United States, West Virginia
West Virginia University, Department of Neurology
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Medical College of Wisconsin, Department of Neurology
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Adele Thorpe Allergan
  Study Documents (Full-Text)

Documents provided by Allergan:
Study Protocol  [PDF] May 19, 2017
Statistical Analysis Plan  [PDF] March 21, 2018

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02867709    
Other Study ID Numbers: UBR-MD-02
First Posted: August 16, 2016    Key Record Dates
Results First Posted: January 29, 2019
Last Update Posted: March 19, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases