Clinical trial NCT06417775: Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Ubrogepant for the Preventive Treatment of Menstrual Migraine With an Open-Label Extension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Migraine
Keywords: Migraine
Menstrual Migraine
Ubrogepant
UBRELVY
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-05-16
Enrollment: 450
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: A migraine is a moderate to severe headache typically on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. Menstrual migraine (MM) is defined as migraine attacks that occur within the perimenstrual period (PMP) in at least 2 out of 3 menstrual cycles. The PMP is from 2 days before the onset of menstrual bleeding to 2 days after. This study will assess how safe and effective ubrogepant is in treating menstrual migraine. Adverse Events and change in disease activity will be assessed.

Ubrogepant is an investigational drug being developed for short-term prevention of menstrual migraine. Participants will be randomly assigned to one of the 2 groups to receive either ubrogepant or placebo. Around 450 adult female participants with menstrual migraine will be enrolled in approximately 100 sites in the United States and Puerto Rico.

Participants will receive oral ubrogepant tablets once daily for 7 consecutive days starting 3 days prior to estimated onset of menses per cycle for 3 PMPs during double-blind period (16 weeks). Eligible participants may continue to receive oral ubrogepant tablets once daily for 7 consecutive days per cycle starting 3 days prior to estimated onset of menses during open-label extension period (52 weeks).

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will collect data daily in electronic diaries and attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria: Inclusion Criteria:

* At least a 1-year history of migraine with or without aura.
* Have experienced migraine attacks in at least 2 of 3 perimenstrual periods (PMPs) during the screening period.
* Collection of daily eDiary data for 3 perimenstrual periods during the up to 16-week screening period to confirm a menstrual migraine (MM) diagnosis.
* Have regular menstrual cycles of between 21-35 days in length.
* Less than 15 headache days per month.
* At least 70% compliance completing screening period and at least 3 out of 5 days of ediary data in each of 3 screening PMP.

Exclusion Criteria:

* History of migraine with brainstem aura, hemiplegic migraine, or retinal migraine.
* Clinically significant history of cardiovascular or cerebrovascular disease per the investigator's opinion.
* Clinically significant abnormalities in the physical examination as determined by the investigator.
* Clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, gynecological, or neurologic disease per the investigator's opinion.
* Acute headache medication overuse.

Primary outcomes:
measure: Change From Baseline in Number of Migraine Days Occurring During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period
timeFrame: Up to approximately 16 Weeks
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to approximately 68 Weeks
Secondary outcomes:
measure: Change From Baseline in Number of Headache Days Occurring During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period
timeFrame: Up to approximately 16 Weeks
measure: Change From Baseline in Number of Moderate or Severe Headache Days During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period
timeFrame: Up to approximately 16 Weeks
measure: Change From Baseline in Number of Migraine Days With Moderate or Severe Headache During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period
timeFrame: Up to approximately 16 Weeks
measure: Percentage of Participants With No Disability/ Mild Impairment for most (>= 65%) of PMP Days
timeFrame: Up to approximately 16 Weeks
measure: Change From Baseline in Acute Medication Use Days During the Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period
timeFrame: Up to approximately 16 Weeks
measure: Percentage of Participants Achieving >= 50% Reduction in Number of Migraine Days During the Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period
timeFrame: Up to approximately 16 Weeks
measure: Percentage of Participants Achieving "Not at all limited" or "A little limited" Daily Activity Level for Most (>= 65%) of PMP Days
timeFrame: Up to approximately 16 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Research Associates /ID# 260161
state: Alabama
city: Chandler
country: United States
facility: MD First Research - Chandler /ID# 262564
state: Arizona
city: Gilbert
country: United States
facility: Gilbert Neurology Partners, PLLC/CCT Research /ID# 260179
state: Arizona
city: Phoenix
country: United States
facility: Foothills Research Center/CCT Research /ID# 260180
state: Arizona
city: Tucson
country: United States
facility: Synexus Clinical Research US, Inc. - Tucson /ID# 258309
state: Arizona
city: Little Rock
country: United States
facility: Preferred Research Partners /ID# 262786
state: Arkansas
city: Little Rock
country: United States
facility: Preferred Research Partners /ID# 273128
state: Arkansas
city: Canoga Park
country: United States
facility: Hope Clinical Research /ID# 257867
state: California
city: Colton
country: United States
facility: Axiom Research /ID# 257833
state: California
city: Fresno
country: United States
facility: Neuro Pain Medical Center /ID# 257155
state: California
city: Glendale
country: United States
facility: Axiom Research, LLC-Los Angeles /ID# 264085
state: California
city: Imperial
country: United States
facility: Sun Valley Research Center /ID# 257152
state: California
city: Irvine
country: United States
facility: Axiom Research - Irvine /ID# 264083
state: California
city: Los Alamitos
country: United States
facility: Collaborative Neuroscience Research CNS /ID# 257828
state: California
city: Los Angeles
country: United States
facility: Los Angeles Headache Center /ID# 257237
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 257158
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research - San Diego /ID# 257134
state: California
city: San Diego
country: United States
facility: WR - Medical Center for Clinical Research /ID# 257897
state: California
city: San Francisco
country: United States
facility: Optimus Medical /ID# 257856
state: California
city: Stamford
country: United States
facility: New England Institute for Clinical Research /ID# 264019
state: Connecticut
city: Boca Raton
country: United States
facility: Neurology Offices of South Florida, PLLC /ID# 257161
state: Florida
city: DeLand
country: United States
facility: Accel Research Sites Network - DeLand Clinical Research Unit /ID# 257403
state: Florida
city: Lakeland
country: United States
facility: Accel Research Sites - Lakeland Clinical Research Unit /ID# 257874
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research /ID# 257199
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare /ID# 257198
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc /ID# 257190
state: Florida
city: Winter Park
country: United States
facility: Conquest Research /ID# 258314
state: Florida
city: Stockbridge
country: United States
facility: Clinical Research Atlanta - Headlands LLC /ID# 260181
state: Georgia
city: Honolulu
country: United States
facility: Hawaii Pacific Neuroscience /ID# 274469
state: Hawaii
city: Meridian
country: United States
facility: Velocity Clinical Research - Boise /ID# 257135
state: Idaho
city: Flossmoor
country: United States
facility: Healthcare Research Network /ID# 257868
state: Illinois
city: Evansville
country: United States
facility: Deaconess Midtown Hospital /ID# 257400
state: Indiana
city: Ames
country: United States
facility: Accellacare - McFarland Clinic /ID# 257834
state: Iowa
city: Newton
country: United States
facility: Alliance for Multispecialty Research LLC /ID# 257839
state: Kansas
city: Overland Park
country: United States
facility: Collective Medical Research /ID# 257131
state: Kansas
city: Wichita
country: United States
facility: Alliance for Multispecialty Research - Wichita East /ID# 257148
state: Kansas
city: Marrero
country: United States
facility: Tandem Clinical Research - Marrero - Barataria Boulevard /ID# 260146
state: Louisiana
city: Monroe
country: United States
facility: IMA Clinical Research Monroe - Wood /ID# 259362
state: Louisiana
city: Baltimore
country: United States
facility: Headlands PharmaSite /ID# 257208
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials /ID# 257132
state: Massachusetts
city: New Bedford
country: United States
facility: BTC of New Bedford /ID# 257128
state: Massachusetts
city: Waltham
country: United States
facility: MedVadis Research /ID# 257156
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Headache & Neurological Institute (MHNI) /ID# 257179
state: Michigan
city: Ridgeland
country: United States
facility: Proven Endpoints LLC /ID# 273796
state: Mississippi
city: Hazelwood
country: United States
facility: HealthCare Research Network - Hazelwood /ID# 257402
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research LLC /ID# 257215
state: Missouri
city: Fremont
country: United States
facility: Methodist Physicians Clinic/CCT Research /ID# 260167
state: Nebraska
city: Papillion
country: United States
facility: Cognitive Clinical Trials (CCT) - Papillion /ID# 260174
state: Nebraska
city: Las Vegas
country: United States
facility: IMA Clinical Research Las Vegas /ID# 258679
state: Nevada
city: Las Vegas
country: United States
facility: Wr-Crcn, Llc /Id# 257895
state: Nevada
city: Toms River
country: United States
facility: Bio Behavioral Health, Inc /ID# 257140
state: New Jersey
city: Warren
country: United States
facility: IMA Clinical Research Warren /ID# 263641
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc. /ID# 257212
state: New Mexico
city: Amherst
country: United States
facility: Dent Neurologic Institute - Amherst /ID# 257219
state: New York
city: Hartsdale
country: United States
facility: IMA Clinical Research Westchester /ID# 259157
state: New York
city: New York
country: United States
facility: Fieve Clinical Research, Inc. /ID# 257177
state: New York
city: New York
country: United States
facility: Rochester Clinical Research /ID# 257193
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates /ID# 257163
state: New York
city: Greensboro
country: United States
facility: Headache Wellness Center /ID# 257136
state: North Carolina
city: Winston-Salem
country: United States
facility: Accellacare /ID# 257731
state: North Carolina
city: Winston-Salem
country: United States
facility: Accellacare /ID# 257850
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research, LLC /ID# 257896
state: North Dakota
city: Cincinnati
country: United States
facility: CTI Clinical Research Center /ID# 257162
state: Ohio
city: Cleveland
country: United States
facility: C7 Research /ID# 272815
state: Ohio
city: Columbus
country: United States
facility: Centricity Research Columbus /ID# 257221
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Institute of Oklahoma City /ID# 257857
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network - Portland - Northwest Vaughn Street /ID# 257139
state: Oregon
city: Abington
country: United States
facility: Abington Neurological Associates - Abington /ID# 257164
state: Pennsylvania
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia, LLC /ID# 257197
state: Pennsylvania
city: Cumberland
country: United States
facility: Clinical Res Collaborative /ID# 257855
state: Rhode Island
city: Greenville
country: United States
facility: Premier Neurology /ID# 260359
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Research Center - North Charleston /ID# 257227
state: South Carolina
city: Chattanooga
country: United States
facility: WR-ClinSearch /ID# 257160
state: Tennessee
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research - Knoxville /ID# 257846
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology /ID# 257186
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP /ID# 257142
state: Texas
city: Houston
country: United States
facility: Houston Clinical Research Associates /ID# 272077
state: Texas
city: Lake Jackson
country: United States
facility: Red Star Research, LLC /ID# 257871
state: Texas
city: Lampasas
country: United States
facility: Radiance Clinical Research /ID# 271727
state: Texas
city: Lewisville
country: United States
facility: Epic Clinical Research - Lewisville /ID# 274480
state: Texas
city: Seabrook
country: United States
facility: Elevate Clinical - Seabrook /ID# 274679
state: Texas
city: Waxahachie
country: United States
facility: Clinpoint Trials /ID# 274524
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute /ID# 257853
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic South /ID# 258305
state: Utah
city: Salt Lake City
country: United States
facility: Highland Clinical Research /ID# 257137
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research /ID# 257154
state: Virginia
city: Norfolk
country: United States
facility: Alliance for Multispecialty Research - Clinical Research Associates /ID# 257851
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center /ID# 257381
state: Washington
city: Tacoma
country: United States
facility: Puget Sound Neurology /ID# 257174
state: Washington
city: Beckley
country: United States
facility: Vaught Neurological Services /ID# 267519
state: West Virginia
city: Morgantown
country: United States
facility: West Virginia Univ School Med /ID# 258898
state: West Virginia
city: Guaynabo
country: Puerto Rico
facility: ISIS Clinical Research Center /ID# 262858
city: San Juan
country: Puerto Rico
facility: Instituto De Neurologia Dra. Ivonne Fraga, Psc /ID# 262852
city: San Juan
country: Puerto Rico
facility: BDH Research /ID# 262851
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: