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)

Migraine Clinical Trial

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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05127954
• Other study ID #: 3110-306-002
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: January 14, 2022
• Est. completion date: May 5, 2027

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1200
• Est. completion date: May 5, 2027
• Est. primary completion date: May 5, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Ubrogepant
Oral Tablet

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Adverse Events (AEs)	An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	up to 54 weeks
Primary	Percentage of Participants with Potentially Clinically Significant Clinical 12-lead Electrocardiogram (ECG)	12-lead resting ECGs will be recorded. Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF).	Up to 54 Weeks
Primary	Percentage of Participants with Potentially Clinically Significant Vital Sign Parameters	Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.	Up to 54 Weeks
Primary	Percentage of Participants with Potentially Clinically Significant lab values	Percentage of participants with abnormal change in clinical laboratory test results like hematology will be assessed.	Up to 54 Weeks
Primary	Percentage of with Participants with Suicidal Ideation or Suicidal Behavior	The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt).	Up to 54 Weeks
Primary	Percentage of Participants with Change in Menstrual Cycle	Female participants who have entered menarche are to be asked for the date of the first and last day of their most recent menstrual period.	Up to 54 Weeks
Primary	Change from baseline in Tanner staging score	Tanner's staging is used to assess growth and pubertal development.	Up to 54 Weeks
Primary	Change From baseline in Behavior Rating Inventory of Executive Function (BRIEF 2) questionnaire	The BRIEF 2 is an 86-item questionnaire assessing executive function. It consists of 2 indexes, Behavioral Regulation and Metacognition, which are then used to calculate an overall composite score. Higher scores indicate more executive difficulties	up to 54 weeks

External Links

•   This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.