Clinical trial NCT05127954: Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Pediatric Participants (Ages 6-17)
Official title: A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6-17)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Migraine
Keywords: Migraine
Ubrogepant
Ubrelvy
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-11-19
Enrollment: 1200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. Migraine is extremely common and disabling in children. The purpose of this study is to evaluate long term safety and tolerability of ubrogepant in the acute treatment of migraine in pediatric participants.

Ubrogepant is a drug approved for the acute treatment of migraine in adults. Pediatric participants (aged 6-17 years) with a history of migraine will be enrolled. Participants who completed the lead-in Study 3110-305-002, as well as those who were placebo responders and screen failed, will be eligible to enroll into this study. Around 1200 participants will be enrolled in the study at approximately 120 sites in the United States.

Participants may receive ubrogepant oral tables to treat up to 8 migraine attacks of any intensity per month. There will be an option to take a second dose of study intervention (identical to initial dose), or rescue medication, starting 2 hours after the initial dose. The study duration will be up to 54 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.


Eligibility criteria: Inclusion Criteria:

* Completers of the lead-in Study 3110-305-002 (in the main study or PK cohort) or those who screen failed due to being placebo responders.
* Demonstrated an acceptable degree of compliance with study procedures in the lead-in study and who, in the investigator's clinical judgment, did not experience an AE that may indicate an unacceptable safety risk for this study.

Exclusion Criteria:

* Requirement for any medication (eg, barbiturates) or diet (eg, grapefruit juice) that is on the list of prohibited concomitant medications that cannot be discontinued or switched to an allowable, alternative medication at Visit 1.
* An ECG with clinically significant abnormalities at Visit 1 as determined by the investigator.
* Clinically significant abnormalities in physical examination at Visit 1, as determined by the investigator.
* Significant risk of self-harm, based on clinical interview and responses on the C-SSRS, or of harm to others in the opinion of the investigator; participants should be excluded if they report suicidal ideation with intent, with or without a plan (ie, Type 4 or 5 on the C-SSRS), or report suicidal behavior at Visit 1
* Any medical or other reason (eg, unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study) that, in the investigator's opinion, might indicate that the participant is unsuitable for the study.

Primary outcomes:
measure: Percentage of Participants with Adverse Events (AEs)
timeFrame: up to 54 weeks
measure: Percentage of Participants with Potentially Clinically Significant Clinical 12-lead Electrocardiogram (ECG)
timeFrame: Up to 54 Weeks
measure: Percentage of Participants with Potentially Clinically Significant Vital Sign Parameters
timeFrame: Up to 54 Weeks
measure: Percentage of Participants with Potentially Clinically Significant lab values
timeFrame: Up to 54 Weeks
measure: Percentage of with Participants with Suicidal Ideation or Suicidal Behavior
timeFrame: Up to 54 Weeks
measure: Percentage of Participants with Change in Menstrual Cycle
timeFrame: Up to 54 Weeks
measure: Change from baseline in Tanner staging score
timeFrame: Up to 54 Weeks
measure: Change From baseline in Behavior Rating Inventory of Executive Function (BRIEF 2) questionnaire
timeFrame: up to 54 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Rehabilitation & Neurological Services /ID# 240054
state: Alabama
city: Saraland
country: United States
facility: The Center for Clinical Trials - Saraland /ID# 239448
state: Alabama
city: Little Rock
country: United States
facility: Preferred Research Partners /ID# 238979
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Research Center /ID# 238967
state: California
city: Fresno
country: United States
facility: Neuro Pain Medical Center /ID# 239135
state: California
city: Lafayette
country: United States
facility: Sunwise Clinical Research /ID# 238458
state: California
city: Long Beach
country: United States
facility: Alliance for Research Alliance for Wellness /ID# 233497
state: California
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles /ID# 239446
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc /ID# 233495
state: California
city: San Jose
country: United States
facility: Lumos Clinical Research Center /ID# 239018
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Management Group /ID# 238503
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado - Aurora /ID# 239838
state: Colorado
city: Centennial
country: United States
facility: IMMUNOe Research Centers /ID# 240846
state: Colorado
city: Colorado Springs
country: United States
facility: MCB Clinical Research Centers /ID# 240999
state: Colorado
city: Washington
country: United States
facility: Emerson Clinical Research Inst /ID# 238455
state: District of Columbia
city: Boynton Beach
country: United States
facility: Encore Medical Research of Boynton Beach LLC /ID# 248720
state: Florida
city: Fort Myers
country: United States
facility: Gulf Coast Clinical Research Center /ID# 233335
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials /ID# 233493
state: Florida
city: Gulf Breeze
country: United States
facility: Northwest Florida Clinical Research Group, LLC /ID# 244396
state: Florida
city: Hialeah
country: United States
facility: A.G.A Clinical Trials /ID# 238409
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research LLC /ID# 247463
state: Florida
city: Homestead
country: United States
facility: Advanced Research Institute of Miami /ID# 240712
state: Florida
city: Lakeland
country: United States
facility: Auzmer Research /ID# 241514
state: Florida
city: Miami
country: United States
facility: Columbus Clinical Services, Llc /Id# 238968
state: Florida
city: Miami
country: United States
facility: My Preferred Research LLC /ID# 239020
state: Florida
city: Miami
country: United States
facility: Neurology & Pain Medicine /ID# 241860
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research Pasco County /ID# 233535
state: Florida
city: Orange City
country: United States
facility: Medical Research Group of Central Florida /ID# 240711
state: Florida
city: Spring Hill
country: United States
facility: Asclepes Research Centers - Spring Hill /ID# 231872
state: Florida
city: Tampa
country: United States
facility: University of South Florida- Neuroscience Institute /ID# 233420
state: Florida
city: Weston
country: United States
facility: Encore Medical Research - Weston /ID# 248335
state: Florida
city: Winter Park
country: United States
facility: Pediatrix Medical Group of Florida /ID# 233336
state: Florida
city: Atlanta
country: United States
facility: Global Research Associates /ID# 243504
state: Georgia
city: Atlanta
country: United States
facility: Rare Disease Research, LLC /ID# 238833
state: Georgia
city: Atlanta
country: United States
facility: Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 238852
state: Georgia
city: Brunswick
country: United States
facility: Coastal Georgia Child Neurology /ID# 240845
state: Georgia
city: Decatur
country: United States
facility: CenExcel iResearch LLC /ID# 239832
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research LLC /ID# 231873
state: Georgia
city: Stockbridge
country: United States
facility: Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 238454
state: Georgia
city: Meridian
country: United States
facility: Velocity Clinical Research - Boise /ID# 238978
state: Idaho
city: Chicago
country: United States
facility: Chicago Headache Center & Research Institute /ID# 254071
state: Illinois
city: Ames
country: United States
facility: Accellacare /ID# 238490
state: Iowa
city: Overland Park
country: United States
facility: College Park Family Care Center Overland Park /ID# 240707
state: Kansas
city: Overland Park
country: United States
facility: Psychiatric Associates /ID# 240710
state: Kansas
city: Wichita
country: United States
facility: Alliance for Multispecialty Research (AMR) - Wichita West /ID# 239829
state: Kansas
city: Baltimore
country: United States
facility: Pharmasite Research, Inc. /ID# 233414
state: Maryland
city: Burnsville
country: United States
facility: Minneapolis Clinic of Neurology - Burnsville /ID# 238828
state: Minnesota
city: Petal
country: United States
facility: MediSync Clinical Research Hattiesburg Clinic /ID# 239837
state: Mississippi
city: Ridgeland
country: United States
facility: Proven Endpoints LLC /ID# 240974
state: Mississippi
city: Ozark
country: United States
facility: Sharlin Health Neuroscience Research Center /ID# 238969
state: Missouri
city: Papillion
country: United States
facility: Cognitive Clinical Trials (CCT) - Papillion /ID# 239835
state: Nebraska
city: Nashua
country: United States
facility: Healthy Perspectives - Innovative Mental Health Services, PLLC /ID# 239441
state: New Hampshire
city: Annandale
country: United States
facility: Hunterdon Neurology /ID# 248222
state: New Jersey
city: Morristown
country: United States
facility: Goryeb Children's Hospital /ID# 239425
state: New Jersey
city: Runnemede
country: United States
facility: CVS HealthHUB - Runnemede /ID# 240057
state: New Jersey
city: Amherst
country: United States
facility: Dent Neurosciences Research Center, Inc. /ID# 238415
state: New York
city: Mount Kisco
country: United States
facility: Bioscience Research /ID# 239442
state: New York
city: New York
country: United States
facility: Modern Migraine MD /ID# 263140
state: New York
city: Port Jefferson Station
country: United States
facility: North Suffolk Neurology /ID# 238457
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University /ID# 241140
state: New York
city: Charlotte
country: United States
facility: CVS HealthHUB - Charlotte /ID# 240842
state: North Carolina
city: Hickory
country: United States
facility: OnSite Clinical Solutions, LLC - Hickory /ID# 238946
state: North Carolina
city: Cincinnati
country: United States
facility: Patient Priority Clinical Sites, LLC /ID# 240051
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati /ID# 238461
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center /ID# 247491
state: Ohio
city: Cincinnati
country: United States
facility: Headache Center of Hope /ID# 244819
state: Ohio
city: Columbus
country: United States
facility: Centricity Research Columbus /ID# 238832
state: Ohio
city: West Chester
country: United States
facility: CincyScience /ID# 233334
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company /ID# 231876
state: Oklahoma
city: Portland
country: United States
facility: Providence Pediatric Neurology - St. Vincent /ID# 240050
state: Oregon
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia - Main /ID# 241138
state: Pennsylvania
city: Scottdale
country: United States
facility: Frontier Clinical Research, LLC - Scottdale /ID# 239017
state: Pennsylvania
city: Smithfield
country: United States
facility: Frontier Clinical Research /ID# 238502
state: Pennsylvania
city: Charleston
country: United States
facility: Coastal Pediatric Research /ID# 240708
state: South Carolina
city: Greenville
country: United States
facility: Tribe Clinical Research LLC /ID# 239143
state: South Carolina
city: Greer
country: United States
facility: Premier Neurology, P.C. /ID# 233419
state: South Carolina
city: Nashville
country: United States
facility: Access Clinical Trials, Inc. /ID# 238414
state: Tennessee
city: Austin
country: United States
facility: UT Health Austin at Dell Children's Neurology Clinic /ID# 246570
state: Texas
city: Austin
country: United States
facility: BioBehavioral Research of Austin /ID# 233427
state: Texas
city: Beaumont
country: United States
facility: Tekton Research - Beaumont /ID# 238407
state: Texas
city: Cedar Park
country: United States
facility: Velocity Clinical Research - Austin /ID# 233406
state: Texas
city: Dallas
country: United States
facility: Relaro Medical Trials /ID# 241141
state: Texas
city: Dallas
country: United States
facility: Cedar Health Research /ID# 233403
state: Texas
city: El Paso
country: United States
facility: 3A Research - East El Paso /ID# 241665
state: Texas
city: Friendswood
country: United States
facility: Earle Research /ID# 238940
state: Texas
city: Houston
country: United States
facility: DM Clinical Research /ID# 238361
state: Texas
city: Houston
country: United States
facility: Houston Clinical Research Associates /ID# 246522
state: Texas
city: Kerrville
country: United States
facility: Sante Clinical Research /ID# 248333
state: Texas
city: Lampasas
country: United States
facility: FMC Science /ID# 240475
state: Texas
city: Mansfield
country: United States
facility: Livingspring Family Medical Center /ID# 252194
state: Texas
city: Plano
country: United States
facility: AIM Trials /ID# 233425
state: Texas
city: San Antonio
country: United States
facility: Road Runner Research /ID# 238360
state: Texas
city: The Woodlands
country: United States
facility: Family Psychiatry of The Woodlands /ID# 238980
state: Texas
city: Waxahachie
country: United States
facility: ClinPoint Trials /ID# 238406
state: Texas
city: Bountiful
country: United States
facility: Pantheon Clinical Research /ID# 251475
state: Utah
city: Salt Lake City
country: United States
facility: Highland Clinical Research /ID# 240053
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Health Hospital /ID# 239021
state: Utah
city: Woodstock
country: United States
facility: Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 240055
state: Vermont
city: Franklin
country: United States
facility: Office of Maria Ona /ID# 239833
state: Virginia
city: Norfolk
country: United States
facility: Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 239142
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research /ID# 238419
state: Virginia
city: Everett
country: United States
facility: Core Clinical Research /ID# 233421
state: Washington
city: Kingwood
country: United States
facility: Frontier Clinical Research - Kingwood /ID# 238459
state: West Virginia
city: Dorado
country: Puerto Rico
facility: Puerto Rico Health Institute /ID# 250560
city: San Juan
country: Puerto Rico
facility: GCM Medical Group PSC /ID# 250561
city: San Juan
country: Puerto Rico
facility: Caribbean Medical Research Center /ID# 265292
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: