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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)

Enrolling by Invitation
PHASE3Ages 6–17InterventionalTreatment
AbbVie
~1,200 participants
Updated 2025-07-20 on ClinicalTrials.gov
What's tested:Ubrogepant

At a glance

Recruiting sites
0 of 113 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants with Adverse Events (AEs)
Measured over up to 54 weeks
+7 more outcomes measured

Conditions

Migraine

Explore related trials

Migraine

Where it's being run

113 sites across 36 states
Florida18
Texas17
California9
Georgia7
Ohio6
New York5
Kansas4
Puerto Rico4

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Percentage of Participants with Adverse Events (AEs)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)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 ParametersUp 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 valuesUp 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 BehaviorUp 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 CycleUp 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 scoreUp 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) questionnaireup 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