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

Primary Purpose

Episodic Migraine

Status
Enrolling by invitation
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Atogepant
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Episodic Migraine focused on measuring Episodic Migraine, Atogepant, QULIPTA, AGN-241689

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants must be between 6 and 17 years of age (inclusive), with a history of episodic migraine. The participant must have completed the lead-in Study M21-201, the pharmacokinetic (PK) substudy in Study M21-201, or completed the 4-week screening/baseline period and screen failed due to not meeting the number of migraine day requirements for the inclusion criteria in Study M21-201, and, in the judgment of the investigator, the participant is an appropriate candidate to be treated with a daily preventive migraine treatment with atogepant (not applicable for de novo migraine participants) 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: History of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018). Have a current diagnosis of chronic migraine as defined by ICHD-3 (2018). Have a current diagnosis of new persistent daily 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.

Sites / Locations

  • Sunwise Clinical Research /ID# 250913
  • Alliance for Research - Long Beach /ID# 250911
  • Excell Research, Inc /ID# 251611
  • Lumos Clinical Research Center /ID# 251608
  • Advanced Neurosciences Research, LLC /ID# 250925
  • Earle Research /ID# 250908
  • Pantheon Clinical Research /ID# 251615

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Atogepant Dose A (12-17 yrs)

Atogepant Dose B (6-11 yrs)

Arm Description

Participant aged 12-17 will receive oral tablets of atogepant Dose A once a day for up to 52 weeks.

Participants aged 6-11 will receive the highest dose of oral tablets of atogepant tested in the lead-in study M21-201.

Outcomes

Primary Outcome Measures

Percentage of Participants with Adverse Events (AEs)
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 Values
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)
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
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
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)
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
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
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

Secondary Outcome Measures

Full Information

First Posted
January 24, 2023
Last Updated
June 6, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT05707949
Brief Title
Long-term Extension Study to Assess Adverse Events of Oral Atogepant Tablets in Pediatric Participants (6 to 17 Years of Age) With Episodic Migraine
Official Title
A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety of Atogepant in Pediatric Subjects 6 to 17 Years of Age With Episodic Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 5, 2023 (Actual)
Primary Completion Date
July 1, 2029 (Anticipated)
Study Completion Date
November 16, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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 episodic migraine. Atogepant is a medicine currently approved to treat adults with episodic 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 episodic migraine. This is a Phase 3, open-label study of atogepant in participants with a history of episodic migraine. Participants must have completed participation in another study of atogepant (lead-in study) or completed the screening period of that study. Participants must have 4 to 14 migraine days and less than 15 headache days in the 4-week screening electronic diary (eDiary; similar to a smart phone). Around 250 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Episodic Migraine
Keywords
Episodic Migraine, Atogepant, QULIPTA, AGN-241689

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atogepant Dose A (12-17 yrs)
Arm Type
Experimental
Arm Description
Participant aged 12-17 will receive oral tablets of atogepant Dose A once a day for up to 52 weeks.
Arm Title
Atogepant Dose B (6-11 yrs)
Arm Type
Experimental
Arm Description
Participants aged 6-11 will receive the highest dose of oral tablets of atogepant tested in the lead-in study M21-201.
Intervention Type
Drug
Intervention Name(s)
Atogepant
Other Intervention Name(s)
QULIPTA, AGN-241689
Intervention Description
Oral Tablet
Primary Outcome Measure Information:
Title
Percentage of Participants with Adverse Events (AEs)
Description
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.
Time Frame
Up to 56 Weeks
Title
Percentage of Participants with Potentially Clinically Significant Lab Values
Description
Percentage of participants with abnormal change in clinical laboratory test results like hematology, chemistry and urinalysis will be assessed.
Time Frame
Up to 52 Weeks
Title
Percentage of Participants with Potentially Clinically Significant Clinical 12-lead Electrocardiogram (ECG)
Description
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).
Time Frame
Up to 52 Weeks
Title
Percentage of Participants with Potentially Clinically Significant Vital Sign Parameters
Description
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Time Frame
Up to 52 Weeks
Title
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
Description
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).
Time Frame
Up to 52 Weeks
Title
Percentage of Participants with Change in Menstrual Cycle (Female Participants Only)
Description
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.
Time Frame
Up to 52 Weeks
Title
Change from Baseline in Tanner Staging Score
Description
Tanner's staging is used to assess growth and pubertal development.
Time Frame
Baseline (Week 0) through Week 52
Title
Change from Baseline in Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF 2) questionnaire
Description
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
Time Frame
Baseline (Week 0) through Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must be between 6 and 17 years of age (inclusive), with a history of episodic migraine. The participant must have completed the lead-in Study M21-201, the pharmacokinetic (PK) substudy in Study M21-201, or completed the 4-week screening/baseline period and screen failed due to not meeting the number of migraine day requirements for the inclusion criteria in Study M21-201, and, in the judgment of the investigator, the participant is an appropriate candidate to be treated with a daily preventive migraine treatment with atogepant (not applicable for de novo migraine participants) 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: History of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018). Have a current diagnosis of chronic migraine as defined by ICHD-3 (2018). Have a current diagnosis of new persistent daily 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Sunwise Clinical Research /ID# 250913
City
Lafayette
State/Province
California
ZIP/Postal Code
94549-4579
Country
United States
Facility Name
Alliance for Research - Long Beach /ID# 250911
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
Excell Research, Inc /ID# 251611
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Lumos Clinical Research Center /ID# 251608
City
San Jose
State/Province
California
ZIP/Postal Code
95124-4108
Country
United States
Facility Name
Advanced Neurosciences Research, LLC /ID# 250925
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Earle Research /ID# 250908
City
Friendswood
State/Province
Texas
ZIP/Postal Code
77546
Country
United States
Facility Name
Pantheon Clinical Research /ID# 251615
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010-4968
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=M21-199
Description
Related Info

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

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