Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants

Migraine Clinical Trial

— UBR Prodrome  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04492020
• Other study ID #: 3110-304-002
• Status: Completed
• Phase: Phase 3
• Start date: August 21, 2020
• Est. completion date: April 19, 2022

Study information

• Verified date: May 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 518
• Est. completion date: April 19, 2022
• Est. primary completion date: April 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Ubrogepant 100 mg
For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours
• Placebo
For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Reporting Absence of Headache of Moderate/Severe Intensity Within 24 Hours Post-dose	The absence of a headache of moderate/severe intensity will be recorded by the participant in an electronic diary (eDiary) within 24 hours after taking double-blind study intervention during the prodrome in order to determine the attenuation of headache. The absence of moderate or severe headache are derived based on headache record and rescue use.	24 hours after taking double-blind study intervention during the prodrome
Secondary	Percentage of Participants Reporting Absence of Headache of Moderate or Severe Intensity Within 48 Hours Post-dose	The absence of a headache of moderate or severe intensity will be recorded by the participant in an eDiary within 48 hours after taking double-blind study intervention during the prodrome in order to determine the prevention of headache	48 hours after taking double-blind study intervention during the prodrome
Secondary	Percentage of Participants Reporting Improvement in the Ability to Function Normally Over 24 Hours Post-dose	The Functional Disability Scale (FDS) is a single item used to measure the participant's level to function normally. Participants will be asked to rate the performance of daily activities using 4 response options ranging from 0 (no disability, able to function normally) to 3 (severely impaired, cannot do all or most things, bed rest may be necessary) within 24 hours after taking double-blind study intervention during the prodrome	24 hours after taking double-blind study intervention during the prodrome
Secondary	Percentage of Participants Reporting Absence of Headache of Any Intensity Within 24 Hours Post-dose	The absence of a headache of moderate/severe intensity will be recorded by the participant in an electronic diary (eDiary) within 24 hours after taking double-blind study intervention during the prodrome in order to determine the attenuation of headache. The absence of moderate or severe headache are derived based on headache record and rescue use.	24 hours after taking double-blind study intervention during the prodrome

External Links

•   Additional information on study locations near you may be found at www.AllerganClinicalTrials.com.