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Enrolling by Invitation

NCT Number: 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)

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research Investigator Group, LLC /ID# 267458, Bayamón, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ubrogepant

Drug

Oral Tablet

Other names: Ubrelvy

Primary outcomes

  1. Percentage of Participants with Adverse Events (AEs)

    Time frame: 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.

  2. Percentage of Participants with Potentially Clinically Significant Clinical 12-lead Electrocardiogram (ECG)

    Time frame: 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).

  3. Percentage of Participants with Potentially Clinically Significant Vital Sign Parameters

    Time frame: 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.

  4. Percentage of Participants with Potentially Clinically Significant lab values

    Time frame: Up to 54 Weeks

    Percentage of participants with abnormal change in clinical laboratory test results like hematology will be assessed.

  5. Percentage of with Participants with Suicidal Ideation or Suicidal Behavior

    Time frame: 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).

  6. Percentage of Participants with Change in Menstrual Cycle

    Time frame: 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.

  7. Change from baseline in Tanner staging score

    Time frame: Up to 54 Weeks

    Tanner's staging is used to assess growth and pubertal development.

  8. Change From baseline in Behavior Rating Inventory of Executive Function (BRIEF 2) questionnaire

    Time frame: 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

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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)

Acronym: UBRO PEDS OLE

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Nov 19, 2021
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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