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

Phase 3

• Conditions: Migraine Prophylaxis
• Interventions: Drug: Atogepant

• Registration Number: NCT05707949
• Lead Sponsor: AbbVie

Brief Summary

A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. A number of treatments are available for adults with migraine but there are limited approved treatments available for participants less than 18 years of age. The main goal of the study is to evaluate the long-term safety and tolerability of atogepant in pediatric participants between the ages of 6 and 17 with migraine.

Atogepant is a medicine currently approved to treat adults with migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of migraine. This is a Phase 3, open-label study of atogepant in participants with a history of migraine. Participants must have completed participation in another study of atogepant (lead-in study). Participants must have 4 to 14 migraine days and less than 15 headache days for episodic migraine, and \>= 15 headache days and \>= 8 migraine days for chronic migraine in the 4-week screening electronic diary (eDiary; similar to a smart phone). Around 650 participants will be enrolled in the study at approximately 100 sites worldwide.

Atogepant is a tablet taken once a day by mouth. Participants between the ages of 12 and 17 will receive high dose atogepant for 52 Weeks. Participants between the ages of 6 and 11 will receive an atogepant dose determined in the lead-in study for 52 Weeks.

There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-24
• Study First Submitted QC: 2023-01-24
• Study First Posted: 2023-02-01
• Study Start: 2023-06-05
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-12
• Primary Completion: 2029-11-15
• Study Completion: 2029-11-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atogepant Dose A (12-17 yrs)	Atogepant	Participant aged 12-17 will receive oral tablets of atogepant Dose A once a day for up to 52 weeks.
Atogepant Dose B (6-11 yrs)	Atogepant	Participants aged 6-11 will receive the highest dose of oral tablets of atogepant tested in the lead-in study M21-201.

Primary Outcome Measures

Name	Time	Method
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 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 Parameters	Up 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 Behaviors	Up 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).
Change from Baseline in Tanner Staging Score	Baseline (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) questionnaire	Baseline (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
Percentage of Participants with Potentially Clinically Significant Lab Values	Up 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 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.

Trial Locations

Locations (86)

Rehabilitation & Neurological Services /ID# 250910; 🇺🇸 Huntsville, Alabama, United States

Preferred Research Partners /ID# 250937; 🇺🇸 Little Rock, Arkansas, United States

Advanced Research Center /ID# 251616; 🇺🇸 Anaheim, California, United States

Sunwise Clinical Research /ID# 250913; 🇺🇸 Lafayette, California, United States

Alliance for Research Alliance for Wellness /ID# 250911; 🇺🇸 Long Beach, California, United States

Excell Research, Inc /ID# 251611; 🇺🇸 Oceanside, California, United States

Lumos Clinical Research Center /ID# 251608; 🇺🇸 San Jose, California, United States

Advanced Neurosciences Research, LLC /ID# 250925; 🇺🇸 Fort Collins, Colorado, United States

Northwest Florida Clinical Research Group, LLC /ID# 251614; 🇺🇸 Gulf Breeze, Florida, United States

Advanced Research Institute of Miami /ID# 250916; 🇺🇸 Homestead, Florida, United States

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