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)
- 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.
- Acronym
- UBRO PEDS OLE
- Short title
- 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)
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Enrolling by invitation
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2028-01-01
- First posted
- 2021-11-19
- Registry last updated
- 2025-07-20
- Primary completion date
- 2028-01-01
- Start date
- 2022-01-14
- Participants
- 1,200
- Participant count basis
- Estimated
- Planned participants
- 1,200
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- AbbVie
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05127954
- ClinicalTrials.gov ID
- NCT05127954
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Percentage of Participants with Adverse Events (AEs)
Timeframe: up to 54 weeks
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.
Percentage of Participants with Potentially Clinically Significant Clinical 12-lead Electrocardiogram (ECG)
Timeframe: Up to 54 Weeks
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).
Percentage of Participants with Potentially Clinically Significant Vital Sign Parameters
Timeframe: Up to 54 Weeks
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Percentage of Participants with Potentially Clinically Significant lab values
Timeframe: Up to 54 Weeks
Percentage of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Percentage of with Participants with Suicidal Ideation or Suicidal Behavior
Timeframe: Up to 54 Weeks
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).
Percentage of Participants with Change in Menstrual Cycle
Timeframe: Up to 54 Weeks
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.
Change from baseline in Tanner staging score
Timeframe: Up to 54 Weeks
Tanner's staging is used to assess growth and pubertal development.
Change From baseline in Behavior Rating Inventory of Executive Function (BRIEF 2) questionnaire
Timeframe: up to 54 weeks
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
- Sex
- All
- Age groups
- Children
- Minimum age
- 6 Years
- Maximum age
- 17 Years
- Healthy volunteers
- No
- 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.
- 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.
- Rehabilitation & Neurological Services /ID# 240054Huntsville, United States
- The Center for Clinical Trials - Saraland /ID# 239448Saraland, United States
- Preferred Research Partners /ID# 238979Little Rock, United States
- Advanced Research Center /ID# 238967Anaheim, United States
- Neuro Pain Medical Center /ID# 239135Fresno, United States
- Alliance for Research Alliance for Wellness /ID# 233497Long Beach, United States
- Children's Hospital Los Angeles /ID# 239446Los Angeles, United States
- Excell Research, Inc /ID# 233495Oceanside, United States
- Paradigm Clinical Research - San Diego /ID# 269611San Diego, United States
- Lumos Clinical Research Center /ID# 239018San Jose, United States
- Pacific Clinical Research Management Group /ID# 238503Upland, United States
- Sunwise Clinical Research /ID# 238458Walnut Creek, United States
- Children's Hospital Colorado - Aurora /ID# 239838Aurora, United States
- IMMUNOe Research Centers /ID# 240846Centennial, United States
- MCB Clinical Research Centers /ID# 240999Colorado Springs, United States
- New England Institute for Clinical Research /ID# 239019Stamford, United States
- Emerson Clinical Research Inst /ID# 238455Washington D.C., United States
- Encore Medical Research of Boynton Beach LLC /ID# 248720Boynton Beach, United States
- Gulf Coast Clinical Research Center /ID# 233335Fort Myers, United States
- Sarkis Clinical Trials /ID# 233493Gainesville, United States
- Northwest Florida Clinical Research Group, LLC /ID# 244396Gulf Breeze, United States
- A.G.A Clinical Trials /ID# 238409Hialeah, United States
- Encore Medical Research /ID# 247463Hollywood, United States
- Advanced Research Institute of Miami /ID# 240712Homestead, United States
- Auzmer Research /ID# 241514Lakeland, United States
And 88 more, listed on the interactive page.
- Related resource (www.rxabbvie.com)
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Migraine disorder Primary condition