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NCT05707949

Long-term Extension Study to Assess Adverse Events of Oral Atogepant Tablets in Pediatric Participants (6 to 17 Years of Age) With Migraine

Enrolling by Invitation
PHASE3Ages 6–17InterventionalTreatment
AbbVie
~650 participants
Updated 2025-08-11 on ClinicalTrials.gov
What's tested:Atogepant

At a glance

Recruiting sites
0 of 86 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 56 Weeks
+7 more outcomes measured

Conditions

Migraine Prophylaxis

Explore related trials

Migraine

Where it's being run

86 sites across 61 states
California5
Texas5
Puerto Rico5
Florida4
Netherlands3
New York2
Ohio2
Utah2

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

Participants must be between 6 and 17 years of age (inclusive), with a history of episodic (ages 6 to 17) or chronic (ages 12 to 17) migraine.
The participant must have completed the lead-in Study M21-201, or the pharmacokinetic (PK) substudy in Study M21-201, or the lead-in Study M23-712.
Weight is \>= 20 kg (44 lbs) and \< 135 kg (298 lbs).
A history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3; 2018) for at least 6 months.

Exclusion

Have a current diagnosis of new daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018).
Have any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular, or neurologic disease.

What this trial measures

  • Percentage of Participants with Adverse Events (AEs)Up to 56 Weeks

    AE, defined as any unfavorable medical event that is temporarily related to the use of the investigational product, which does not necessarily have a causal relationship with the investigational product.

  • Percentage of Participants with Potentially Clinically Significant Lab ValuesUp to 52 Weeks

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

  • Percentage of Participants with Potentially Clinically Significant Clinical 12-lead Electrocardiogram (ECG)Up to 52 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 52 Weeks

    Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.

  • Percentage of with Participants with Treatment-Emergent Suicidal Ideations with Intent, with or without a Plan (i.e., Type 4 or 5 on Columbia-Suicide Severity Rating Scale [C-SSRS]), or any Suicidal BehaviorsUp to 52 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 (Female Participants Only)Up to 52 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 ScoreBaseline (Week 0) through Week 52

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

  • Change from Baseline in Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF 2) questionnaireBaseline (Week 0) through Week 52

    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