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

Status: Recruiting
Location: See all (99) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
Central Research Associates /ID# 260161
COMPLETED
Birmingham
Rehabilitation & Neurological Services /ID# 275593
RECRUITING
Huntsville
Arkansas
Preferred Research Partners /ID# 262786
RECRUITING
Little Rock
Preferred Research Partners /ID# 273128
RECRUITING
Little Rock
Arizona
MD First Research - Chandler /ID# 262564
RECRUITING
Chandler
Gilbert Neurology /ID# 260179
RECRUITING
Gilbert
Foothills Research Center/CCT Research /ID# 260180
RECRUITING
Phoenix
Trialmed-Synexus Clinical Research US, Inc. - Tucson /ID# 258309
RECRUITING
Tucson
California
Hope Clinical Research /ID# 257867
RECRUITING
Canoga Park
Axiom Research /ID# 257833
RECRUITING
Colton
Neuro Pain Medical Center /ID# 257155
RECRUITING
Fresno
Axiom Research, LLC-Los Angeles /ID# 264085
RECRUITING
Glendale
Sun Valley Research Center /ID# 257152
RECRUITING
Imperial
Axiom Research - Irvine /ID# 264083
RECRUITING
Irvine
Collaborative Neuroscience Research CNS /ID# 257828
RECRUITING
Los Alamitos
Los Angeles Headache Center /ID# 257237
RECRUITING
Los Angeles
Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 257158
RECRUITING
Newport Beach
Artemis Institute for Clinical Research - San Diego /ID# 257134
RECRUITING
San Diego
WR - Medical Center for Clinical Research /ID# 257897
RECRUITING
San Diego
Optimus Medical /ID# 257856
RECRUITING
San Francisco
Connecticut
New England Institute for Clinical Research /ID# 264019
RECRUITING
Stamford
Florida
Neurology Offices of South Florida, PLLC /ID# 257161
RECRUITING
Boca Raton
Accel Research Sites Network - DeLand Clinical Research Unit /ID# 257403
RECRUITING
Deland
Accel Research Sites - Lakeland Clinical Research Unit /ID# 257874
RECRUITING
Lakeland
Well Pharma Medical Research /ID# 257199
RECRUITING
Miami
Sensible Healthcare /ID# 257198
RECRUITING
Ocoee
Clinical Neuroscience Solutions, Inc /ID# 257190
RECRUITING
Orlando
Conquest Research /ID# 258314
RECRUITING
Winter Park
Georgia
NeuroTrials Research /ID# 274507
RECRUITING
Atlanta
Clinical Research Atlanta - Headlands LLC /ID# 260181
RECRUITING
Stockbridge
Hawaii
Hawaii Pacific Neuroscience /ID# 274469
RECRUITING
Honolulu
Iowa
Accellacare - McFarland Clinic /ID# 257834
RECRUITING
Ames
Idaho
Velocity Clinical Research - Boise /ID# 257135
RECRUITING
Meridian
Illinois
Healthcare Research Network /ID# 257868
RECRUITING
Tinley Park
Indiana
Deaconess Midtown Hospital /ID# 257400
RECRUITING
Evansville
Kansas
Alliance for Multispecialty Research LLC /ID# 257839
RECRUITING
Newton
Collective Medical Research /ID# 257131
RECRUITING
Overland Park
Alliance for Multispecialty Research - Wichita East /ID# 257148
RECRUITING
Wichita
Louisiana
Tandem Clinical Research - Marrero - Barataria Boulevard /ID# 260146
RECRUITING
Marrero
IMA Clinical Research Monroe - Wood /ID# 259362
RECRUITING
Monroe
Massachusetts
Boston Clinical Trials /ID# 257132
RECRUITING
Boston
BTC of New Bedford /ID# 257128
COMPLETED
New Bedford
MedVadis Research /ID# 257156
RECRUITING
Waltham
Maryland
Headlands PharmaSite /ID# 257208
RECRUITING
Baltimore
Michigan
Michigan Headache & Neurological Institute (MHNI) /ID# 257179
RECRUITING
Ann Arbor
Missouri
HealthCare Research Network - Hazelwood /ID# 257402
RECRUITING
Hazelwood
Clinvest Research LLC /ID# 257215
RECRUITING
Springfield
Mississippi
Proven Endpoints LLC /ID# 273796
RECRUITING
Ridgeland
North Carolina
Headache Wellness Center /ID# 257136
RECRUITING
Greensboro
Accellacare /ID# 257731
RECRUITING
Winston-salem
Accellacare /ID# 257850
RECRUITING
Winston-salem
North Dakota
Lillestol Research, LLC /ID# 257896
COMPLETED
Fargo
Nebraska
Methodist Physicians Clinic/CCT Research /ID# 260167
RECRUITING
Fremont
Cognitive Clinical Trials (CCT) - Papillion /ID# 260174
RECRUITING
Papillion
New Jersey
Bio Behavioral Health, Inc /ID# 257140
RECRUITING
Toms River
IMA Clinical Research Warren /ID# 263641
RECRUITING
Warren Township
New Mexico
Albuquerque Clinical Trials, Inc. /ID# 257212
RECRUITING
Albuquerque
Nevada
IMA Clinical Research Las Vegas /ID# 258679
COMPLETED
Las Vegas
Wr-Crcn, Llc /Id# 257895
RECRUITING
Las Vegas
New York
Dent Neurologic Institute - Amherst /ID# 257219
RECRUITING
Amherst
IMA Clinical Research Westchester /ID# 259157
RECRUITING
Hartsdale
Fieve Clinical Research, Inc. /ID# 257177
RECRUITING
New York
Rochester Clinical Research /ID# 257193
RECRUITING
New York
Upstate Clinical Research Associates /ID# 257163
RECRUITING
Williamsville
Ohio
CTI Clinical Research Center /ID# 257162
RECRUITING
Cincinnati
C7 Research /ID# 272815
RECRUITING
Cleveland
Centricity Research Columbus /ID# 257221
RECRUITING
Columbus
Wright State Physicians Health Center /ID# 274708
RECRUITING
Fairborn
Oklahoma
Lynn Institute of Oklahoma City /ID# 257857
RECRUITING
Oklahoma City
Oregon
Summit Research Network - Portland - Northwest Vaughn Street /ID# 257139
RECRUITING
Portland
Pennsylvania
Abington Neurological Associates - Abington /ID# 257164
RECRUITING
Abington
Clinical Research of Philadelphia, LLC /ID# 257197
RECRUITING
Philadelphia
Rhode Island
Partners In Clinical Research /ID# 257855
RECRUITING
Cumberland
South Carolina
Premier Neurology /ID# 260359
RECRUITING
Greenville
Coastal Carolina Research Center - North Charleston /ID# 257227
RECRUITING
North Charleston
Tennessee
WR-ClinSearch /ID# 257160
RECRUITING
Chattanooga
KCA Neurology /ID# 274495
RECRUITING
Franklin
Alliance for Multispecialty Research - Knoxville /ID# 257846
RECRUITING
Knoxville
Texas
FutureSearch Trials of Neurology /ID# 257186
RECRUITING
Austin
FutureSearch Trials of Dallas, LP /ID# 257142
RECRUITING
Dallas
Houston Clinical Research Associates /ID# 272077
RECRUITING
Houston
Red Star Research, LLC /ID# 257871
RECRUITING
Lake Jackson
Radiance Clinical Research /ID# 271727
RECRUITING
Lampasas
Epic Clinical Research - Lewisville /ID# 274480
RECRUITING
Lewisville
Elevate Clinical - Seabrook /ID# 274679
RECRUITING
Seabrook
Clinpoint Trials /ID# 274524
RECRUITING
Waxahachie
Utah
Advanced Research Institute /ID# 257853
RECRUITING
Ogden
Highland Clinical Research /ID# 257137
RECRUITING
Salt Lake City
J. Lewis Research, Inc. / Foothill Family Clinic South /ID# 258305
RECRUITING
Salt Lake City
Virginia
Charlottesville Medical Research /ID# 257154
RECRUITING
Charlottesville
Alliance for Multispecialty Research - Clinical Research Associates /ID# 257851
RECRUITING
Norfolk
Washington
Northwest Clinical Research Center /ID# 257381
RECRUITING
Bellevue
Puget Sound Neurology /ID# 257174
RECRUITING
Tacoma
Wisconsin
Mind+ Neurology /ID# 274486
RECRUITING
Mequon
West Virginia
Vaught Neurological Services /ID# 267519
RECRUITING
Beckley
West Virginia Univ School Med /ID# 258898
RECRUITING
Morgantown
Other Locations
Puerto Rico
ISIS Clinical Research Center /ID# 262858
RECRUITING
Guaynabo
BDH Research /ID# 262851
RECRUITING
San Juan
Instituto De Neurologia Dra. Ivonne Fraga, Psc /ID# 262852
RECRUITING
San Juan
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2024-09-10
Estimated Completion Date: 2027-09
Participants
Target number of participants: 450
Treatments
Experimental: Double-Blind Period: Ubrogepant
Participants will receive ubrogepant during the double-blind period.
Experimental: Double-Blind Period: Placebo for Ubrogepant
Participants will receive placebo during the double-blind period.
Experimental: Open-Label Extension Period: Ubrogepant
Eligible participants from Double-Blind period may continue to receive ubrogepant during the open-label extension period.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

Similar Clinical Trials