Clinical trial NCT04492020: Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Keywords: Migraine
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-07-30
Enrollment: 518
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome


Eligibility criteria: Inclusion Criteria:

* At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the ICHD-3 (International Classification of Headache Disorders 3rd edition)
* Migraine onset before age 50 years
* By history, the participant's migraines typically last 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 in each of the 3 months prior to the Screening Visit

Exclusion Criteria:

* Difficulty distinguishing migraine headache from tension-type or other headaches
* Participants who overuse medication for migraine defined as use of opioids or barbiturates \> 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (eg, aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1 per investigator's judgment
* Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3
* A current diagnosis of chronic migraine as defined by ICHD-3 or a history of 15 or more headache days per month on average in the 6 months prior to Visit 1 in the investigator's judgment. A headache day is defined as a day in which there was any occurrence of a headache of a minimum duration of 2 hours or a headache of any duration for which acute medication was taken
* Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3
* Required hospital treatment of a migraine attack 3 or more times in the 6 months prior to Visit 1
* History of malignancy in the 5 years prior to Visit 1, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
* History of any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory bowel disease) that, per investigator judgment, may affect the absorption or metabolism of the study intervention; participants with prior gastric bariatric interventions (eg, Lap Band) which have been reversed are not excluded

Primary outcomes:
measure: Percentage of Participants Reporting Absence of Headache of Moderate/Severe Intensity Within 24 Hours Post-dose
timeFrame: 24 hours after taking double-blind study intervention during the prodrome
Secondary outcomes:
measure: Percentage of Participants Reporting Absence of Headache of Moderate or Severe Intensity Within 48 Hours Post-dose
timeFrame: 48 hours after taking double-blind study intervention during the prodrome
measure: Percentage of Participants Reporting Improvement in the Ability to Function Normally Over 24 Hours Post-dose
timeFrame: 24 hours after taking double-blind study intervention during the prodrome
measure: Percentage of Participants Reporting Absence of Headache of Any Intensity Within 24 Hours Post-dose
timeFrame: 24 hours after taking double-blind study intervention during the prodrome
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research, LLC /ID# 237098
state: Alabama
city: Phoenix
country: United States
facility: Barrow Neuro Institute /ID# 236775
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Clinical Research /ID# 238032
state: Arkansas
city: Fresno
country: United States
facility: California Headache and Balance Center /ID# 236247
state: California
city: Imperial
country: United States
facility: Sun Valley Research Center /ID# 236561
state: California
city: Los Alamitos
country: United States
facility: Wr-Pri Llc /Id# 236007
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 237691
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc /ID# 237721
state: California
city: Torrance
country: United States
facility: George J. Rederich M.D. Inc. /ID# 235769
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research /ID# 237570
state: California
city: Colorado Springs
country: United States
facility: Colorado Springs Neurological Associates (CSNA) /ID# 236556
state: Colorado
city: Fort Collins
country: United States
facility: Advanced Neurosciences Research, LLC /ID# 237426
state: Colorado
city: Jacksonville
country: United States
facility: CNS Healthcare - Jacksonville /ID# 238245
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc - Jupiter /ID# 236226
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research /ID# 236934
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare /ID# 238090
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc /ID# 236608
state: Florida
city: Saint Petersburg
country: United States
facility: Accel Research Sites - St Petersburg Clinical Research Unit /ID# 237163
state: Florida
city: Tampa
country: United States
facility: University of South Florida /ID# 234387
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research /ID# 237092
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute - Palm Beach /ID# 238193
state: Florida
city: Atlanta
country: United States
facility: NeuroTrials Research Inc. /ID# 237365
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta, LLC /ID# 237390
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research (Neurology) - Savannah /ID# 234371
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta - Headlands LLC /ID# 234438
state: Georgia
city: Boise
country: United States
facility: Northwest Clinical Trials /ID# 234968
state: Idaho
city: Evansville
country: United States
facility: Deaconess Clinic Downtown /ID# 236959
state: Indiana
city: Ames
country: United States
facility: PMG Research of McFarland /ID# 238271
state: Iowa
city: Overland Park
country: United States
facility: Collective Medical Research /ID# 236402
state: Kansas
city: Overland Park
country: United States
facility: Kansas Institute of Research /ID# 236738
state: Kansas
city: Boston
country: United States
facility: Boston Clinical Trials /ID# 236559
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Headache & Neurological Institute (MHNI) /ID# 236565
state: Michigan
city: Golden Valley
country: United States
facility: Minneapolis Clinic of Neurology - Golden Valley /ID# 238162
state: Minnesota
city: Minneapolis
country: United States
facility: Clinical Research Institute, Inc /ID# 238301
state: Minnesota
city: Saint Peters
country: United States
facility: StudyMetrix Research /ID# 236457
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research LLC /ID# 237908
state: Missouri
city: Skillman
country: United States
facility: Princeton Center for Clinical Research /ID# 235734
state: New Jersey
city: Toms River
country: United States
facility: Bio Behavioral Health, Inc /ID# 238212
state: New Jersey
city: Amherst
country: United States
facility: Dent Neurosciences Research Center, Inc. /ID# 237039
state: New York
city: Manlius
country: United States
facility: Central New York Clinical Research /ID# 235694
state: New York
city: New York
country: United States
facility: Rochester Clinical Research /ID# 236842
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates /ID# 238220
state: New York
city: Charlotte
country: United States
facility: PMG Research of Charlotte /ID# 237048
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates /ID# 237138
state: North Carolina
city: Cincinnati
country: United States
facility: CTI Clinical Research Center /ID# 237278
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati /ID# 234403
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research Columbus /ID# 236837
state: Ohio
city: Edmond
country: United States
facility: OK Clinical Research /ID# 236675
state: Oklahoma
city: Oklahoma City
country: United States
facility: IPS Research Company /ID# 237674
state: Oklahoma
city: Portland
country: United States
facility: Summit Headlands LLC /ID# 236077
state: Oregon
city: Abington
country: United States
facility: Abington Neurological Associates - Abington /ID# 236257
state: Pennsylvania
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research /ID# 236703
state: Pennsylvania
city: Media
country: United States
facility: Suburban Research Associates - Media /ID# 236698
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Jefferson Headache Center /ID# 235821
state: Pennsylvania
city: Smithfield
country: United States
facility: Frontier Clinical Research /ID# 237924
state: Pennsylvania
city: Charleston
country: United States
facility: Clinical Trials of SC /ID# 237338
state: South Carolina
city: Chattanooga
country: United States
facility: WR-ClinSearch /ID# 238287
state: Tennessee
city: Memphis
country: United States
facility: CNS Healthcare - Memphis /ID# 236396
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology /ID# 236428
state: Texas
city: Austin
country: United States
facility: Tekton Research, Inc. /ID# 237306
state: Texas
city: Bryan
country: United States
facility: DiscoveResearch, Inc /ID# 236273
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP /ID# 236276
state: Texas
city: Houston
country: United States
facility: Centex Studies, Inc. - Houston /ID# 237458
state: Texas
city: Waxahachie
country: United States
facility: ClinPoint Trials /ID# 236618
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute /ID# 237749
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah /ID# 237602
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research /ID# 237792
state: Virginia
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc. (HRHR) /ID# 237253
state: Virginia
city: Virginia Beach
country: United States
facility: Tidewater Integr Med Research /ID# 236867
state: Virginia
city: Virginia Beach
country: United States
facility: Sentara Neurology Specialists - Virginia Beach /ID# 234350
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center /ID# 237585
state: Washington
city: Seattle
country: United States
facility: Seattle Clinical Research Center /ID# 236912
state: Washington
city: Tacoma
country: United States
facility: Puget Sound Neurology /ID# 236322
state: Washington
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: