Clinical trial NCT02828020: Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine, With or Without Aura
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2016-07-11
Enrollment: 1672
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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 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, diarrhea 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.

Primary outcomes:
measure: Percentage of Participants With Pain Freedom at 2 Hours After Initial Dose
timeFrame: Baseline (Predose) to 2 hours after initial dose
measure: Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose
timeFrame: Baseline (Predose) to 2 hours after initial dose
Secondary outcomes:
measure: Percentage of Participants With Pain Relief at 2 Hours After the Initial Dose
timeFrame: Baseline (Predose) to 2 hours after initial dose
measure: Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours After Initial Dose
timeFrame: 2 to 24 hours after initial dose
measure: Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose
timeFrame: 2 to 24 hours after initial dose
measure: Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose
timeFrame: 2 hours after initial dose
measure: Percentage of Participants With the Absence of Phonophobia at 2 Hours After the Initial Dose
timeFrame: 2 hours after initial dose
measure: Percentage of Participants With Absence of Nausea at 2 Hours After the Initial Dose
timeFrame: 2 hours after initial dose
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Clinical Research Advantage, Inc./Desert Clinical Research, LLC.
state: Arizona
city: Phoenix
country: United States
facility: Xenoscience, Inc.
state: Arizona
city: Tucson
country: United States
facility: Clinical Research Advantage, Inc./Orange Grove Family Practice
state: Arizona
city: Hot Springs
country: United States
facility: Principals Research Group, Inc.
state: Arkansas
city: Little Rock
country: United States
facility: KLR Business Group, Inc. dba Arkansas Clinical Research
state: Arkansas
city: Carlsbad
country: United States
facility: The Research Center of Southern California, LLC
state: California
city: Carmichael
country: United States
facility: Med Center
state: California
city: Encino
country: United States
facility: T. Joseph Raoof MD, Inc./Encino Research Center
state: California
city: Fullerton
country: United States
facility: Neurology Center of North Orange County
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists, LLC
state: California
city: Laguna Hills
country: United States
facility: Prime Care Clinical Research
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network, LLC.
state: California
city: National City
country: United States
facility: Synergy San Diego
state: California
city: Newport Beach
country: United States
facility: Newport Beach Clinical Research Associates, Inc.
state: California
city: Oceanside
country: United States
facility: North County Clinical Research
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: Santa Monica
country: United States
facility: CA Medical Clinic for Headache
state: California
city: Simi Valley
country: United States
facility: Southern California Research LLC
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Boulder
country: United States
facility: Alpine Clinical Research Center, Inc.
state: Colorado
city: Colorado Springs
country: United States
facility: Colorado Springs Neurological Associates
state: Colorado
city: Colorado Springs
country: United States
facility: Delta Waves, Inc
state: Colorado
city: Denver
country: United States
facility: Denver Neurological Research
state: Colorado
city: Danbury
country: United States
facility: Associated Neurologists, P.C.
state: Connecticut
city: Fairfield
country: United States
facility: Associated Neurolgists of Southern Connecticut, PC
state: Connecticut
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Hallandale Beach
country: United States
facility: CPI MD Clinical
state: Florida
city: Hollywood
country: United States
facility: Infinity Clinical Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Palm Beach Gardens
country: United States
facility: Palm Beach Neurological Center/Advanced Research Consultants, Inc.
state: Florida
city: Spring Hill
country: United States
facility: Meridien Research
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: West Palm Beach
country: United States
facility: Neurology Research Institute
state: Florida
city: Atlanta
country: United States
facility: Midtown Neurology
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Chicago
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
city: Newburgh
country: United States
facility: Deaconess Clinic, Medical Office Building 1 Research Institute
state: Indiana
city: Lenexa
country: United States
facility: Rowe Neurology Institute
state: Kansas
city: Overland Park
country: United States
facility: Kansas Institute of Research
state: Kansas
city: Overland Park
country: United States
facility: College Park Family Care Center Physicians Group - Neurology Research Department
state: Kansas
city: Bardstown
country: United States
facility: Kentucky Pediatric/Adult Research
state: Kentucky
city: Baltimore
country: United States
facility: Pharmasite Research, Inc.
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: South Dartmouth
country: United States
facility: Northeast Medical Research Associates, Inc
state: Massachusetts
city: Watertown
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Head-Pain & Neurological Institute
state: Michigan
city: Kalamazoo
country: United States
facility: Beyer Research
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Institute, Inc.
state: Minnesota
city: Olive Branch
country: United States
facility: Olive Branch Family Medical Center
state: Mississippi
city: Springfield
country: United States
facility: Clinvest Research, LLC
state: Missouri
city: Omaha
country: United States
facility: Quality Clinical Research, Inc.
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Research Advantage, Inc./Diagnostic Center of Medicine - Durango
state: Nevada
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc.
state: New Mexico
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience, Inc.
state: New Mexico
city: Endwell
country: United States
facility: Regional Clinical Research, Inc.
state: New York
city: Manlius
country: United States
facility: Central New York Clinical Research
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Hickory
country: United States
facility: Neurology Associates, P.A.
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem, LLC.
state: North Carolina
city: Canton
country: United States
facility: Neuro-Behavioral Clinical Research, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research, Inc
state: Ohio
city: Lyndhurst
country: United States
facility: Ohio Clinical Research, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: MPH IPS Research Company
state: Oklahoma
city: Oklahoma City
country: United States
facility: NPC Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network
state: Oregon
city: Portland
country: United States
facility: Oregon Center For Clinical Investigations Inc. (OCCI, Inc.)
state: Oregon
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia, LLC
state: Pennsylvania
city: Lincoln
country: United States
facility: BTC of Lincoln
state: Rhode Island
city: Chattanooga
country: United States
facility: WR-ClinSearch, LLC
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Austin
country: United States
facility: Tekton Research, Inc.
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP
state: Texas
city: Lake Jackson
country: United States
facility: Red Star Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials Texas, Inc
state: Texas
city: San Antonio
country: United States
facility: Road Runner Research, Ltd.
state: Texas
city: Draper
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic Draper
state: Utah
city: Riverton
country: United States
facility: Granger Medical Clinic-Riverton
state: Utah
city: Salt Lake City
country: United States
facility: Optimum Clinical Research, Inc.
state: Utah
city: Salt Lake City
country: United States
facility: Highland Clinical Research
state: Utah
city: Virginia Beach
country: United States
facility: Tidewater Integrated Medical Research
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: The Polyclinic Madison Center
state: Washington
Study officials:
affiliation: Allergan
name: Adele Thorpe
role: STUDY_DIRECTOR
References:
citation: Johnston KM, Powell L, Popoff E, Harris L, Croop R, Coric V, L'Italien G. Rimegepant, Ubrogepant, and Lasmiditan in the Acute Treatment of Migraine Examining the Benefit-Risk Profile Using Number Needed to Treat/Harm. Clin J Pain. 2022 Nov 1;38(11):680-685. doi: 10.1097/AJP.0000000000001072.
citation: Lipton RB, Singh RBH, Revicki DA, Zhao S, Shewale AR, Lateiner JE, Dodick DW. Functionality, satisfaction, and global impression of change with ubrogepant for the acute treatment of migraine in triptan insufficient responders: a post hoc analysis of the ACHIEVE I and ACHIEVE II randomized trials. J Headache Pain. 2022 Apr 25;23(1):50. doi: 10.1186/s10194-022-01419-7.
citation: Blumenfeld AM, Knievel K, Manack Adams A, Severt L, Butler M, Lai H, Dodick DW. Ubrogepant Is Safe and Efficacious in Participants Taking Concomitant Preventive Medication for Migraine: A Pooled Analysis of Phase 3 Trials. Adv Ther. 2022 Jan;39(1):692-705. doi: 10.1007/s12325-021-01923-3. Epub 2021 Dec 7.
citation: Hutchinson S, Silberstein SD, Blumenfeld AM, Lipton RB, Lu K, Yu SY, Severt L. Safety and efficacy of ubrogepant in participants with major cardiovascular risk factors in two single-attack phase 3 randomized trials: ACHIEVE I and II. Cephalalgia. 2021 Aug;41(9):979-990. doi: 10.1177/03331024211000311. Epub 2021 Apr 19.
citation: Hutchinson S, Dodick DW, Treppendahl C, Bennett NL, Yu SY, Guo H, Trugman JM. Ubrogepant for the Acute Treatment of Migraine: Pooled Efficacy, Safety, and Tolerability From the ACHIEVE I and ACHIEVE II Phase 3 Randomized Trials. Neurol Ther. 2021 Jun;10(1):235-249. doi: 10.1007/s40120-021-00234-7. Epub 2021 Feb 20.
citation: Goadsby PJ, Blumenfeld AM, Lipton RB, Dodick DW, Kalidas K, M Adams A, Jakate A, Liu C, Szegedi A, Trugman JM. Time course of efficacy of ubrogepant for the acute treatment of migraine: Clinical implications. Cephalalgia. 2021 Apr;41(5):546-560. doi: 10.1177/0333102420970523. Epub 2020 Nov 26.
citation: Dodick DW, Lipton RB, Ailani J, Lu K, Finnegan M, Trugman JM, Szegedi A. Ubrogepant for the Treatment of Migraine. N Engl J Med. 2019 Dec 5;381(23):2230-2241. doi: 10.1056/NEJMoa1813049.