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)

Condition(s) studied

Investigational drug(s) / intervention(s)

Ubrogepant: Oral Tablet

Study 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

Primary outcome measure(s)

• 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 Parameters — 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 — 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 — 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 — 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 — 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 — 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

Trial sites (113)

+ 73 more sites — see the full list on the official registry below.

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