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

Episodic Migraine Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05707949
• Other study ID #: M21-199
• Secondary ID: 2022-501099-24-0
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: June 5, 2023
• Est. completion date: November 16, 2029

Study information

• Verified date: February 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: November 16, 2029
• Est. primary completion date: November 16, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Episodic Migraine
• Migraine Disorders

Intervention

Drug:
• Atogepant
Oral Tablet

Locations

Country	Name	City	State
Canada	Montreal Children's Hospital /ID# 250649	Montreal	Quebec
Denmark	Aalborg Universitetshospital /Id# 247429	Aalborg	Nordjylland
Denmark	Regionshospitalet Godstrup /ID# 247903	Herning	Midtjylland
Hungary	Mind Klinika Kft. /ID# 251597	Budapest
Hungary	Semmelweis Egyetem /ID# 251593	Budapest
Israel	Shamir Medical Center (Assaf Harofeh) /ID# 256858	Be'er Yaakov	HaMerkaz
Israel	Hillel Yaffe Medical Center /ID# 248923	Hadera	H_efa
Italy	Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 249182	Milan
Italy	Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 249184	Palermo
Japan	Konan Medical Center /ID# 254458	Kobe-shi	Hyogo
Japan	Umenotsuji Clinic /ID# 254454	Kochi-shi	Kochi
Japan	Tatsuoka Neurology Clinic /ID# 254456	Kyoto
Japan	Yamaguchi Clinic /ID# 254763	Nishinomiya-shi	Hyogo
Japan	Tominaga Clinic /ID# 254451	Osaka-shi	Osaka
Japan	Sendai Headache and Neurology Clinic Medical Corporation /ID# 254212	Sendai-shi	Miyagi
Japan	Tokyo Medical University Hospital /ID# 254460	Shinjuku-ku	Tokyo
Poland	Athleticomed Sp. z o.o /ID# 250620	Bydgoszcz
Poland	Specjalistyczne Gabinety Sp. z o.o. /ID# 250625	Krakow	Malopolskie
Poland	Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 250622	Lublin	Lubelskie
Poland	Clinical Research Center Sp. z.o.o. Medic-R sp. k /ID# 250623	Poznan	Wielkopolskie
Poland	OHA-MED sp. z o.o /ID# 250621	Warszawa	Mazowieckie
Poland	MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 250624	Wroclaw
Puerto Rico	Puerto Rico Health Institute /ID# 250949	Dorado
Puerto Rico	Caribbean Medical Research Center /ID# 253156	San Juan
Spain	Hospital Universitario Vall d'Hebron /ID# 248457	Barcelona
Spain	Hospital Clinico Universitario San Carlos /ID# 249268	Madrid
Spain	Hospital Universitario Virgen del Rocio /ID# 248633	Sevilla
Spain	Hospital Universitario y Politecnico La Fe /ID# 248459	Valencia
Sweden	Vastra Gotealandsregionen Regionhalsan /ID# 248981	Molnlycke
United Kingdom	NHS Grampian /ID# 251474	Aberdeen
United States	Dent Neurosciences Research Center, Inc. /ID# 250915	Amherst	New York
United States	Advanced Research Center /ID# 251616	Anaheim	California
United States	Michigan Headache & Neurological Institute (MHNI) /ID# 250920	Ann Arbor	Michigan
United States	FutureSearch Trials of Neurology /ID# 251613	Austin	Texas
United States	Pantheon Clinical Research /ID# 251615	Bountiful	Utah
United States	Coastal Georgia Child Neurology /ID# 250938	Brunswick	Georgia
United States	Patient Priority Clinical Sites, LLC /ID# 250922	Cincinnati	Ohio
United States	3A Research - East El Paso /ID# 250909	El Paso	Texas
United States	Core Clinical Research /ID# 250932	Everett	Washington
United States	Advanced Neurosciences Research, LLC /ID# 250925	Fort Collins	Colorado
United States	Office of Maria Ona /ID# 250939	Franklin	Virginia
United States	Earle Research /ID# 250908	Friendswood	Texas
United States	Headache Wellness Center /ID# 251612	Greensboro	North Carolina
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	Rehabilitation & Neurological Services /ID# 250910	Huntsville	Alabama
United States	Sunwise Clinical Research /ID# 250913	Lafayette	California
United States	Preferred Research Partners /ID# 250937	Little Rock	Arkansas
United States	Alliance for Research - Long Beach /ID# 250911	Long Beach	California
United States	My Preferred Research LLC /ID# 250931	Miami	Florida
United States	Goryeb Children's Hospital /ID# 250934	Morristown	New Jersey
United States	Access Clinical Trials, Inc. /ID# 250914	Nashville	Tennessee
United States	Deaconess Clinic - Gateway Health Center /ID# 250923	Newburgh	Indiana
United States	Excell Research, Inc /ID# 251611	Oceanside	California
United States	Lynn Health Science Institute (LHSI) /ID# 250926	Oklahoma City	Oklahoma
United States	College Park Family Care Center Overland Park /ID# 251609	Overland Park	Kansas
United States	Cognitive Clinical Trials (CCT) - Papillion /ID# 251610	Papillion	Nebraska
United States	Proven Endpoints LLC /ID# 258083	Ridgeland	Mississippi
United States	Highland Clinical Research /ID# 250924	Salt Lake City	Utah
United States	Lumos Clinical Research Center /ID# 251608	San Jose	California
United States	Asclepes Research Centers - Spring Hill /ID# 250912	Spring Hill	Florida
United States	Family Psychiatry of The Woodlands /ID# 250936	The Woodlands	Texas
United States	ClinPoint Trials /ID# 250942	Waxahachie	Texas
United States	CincyScience /ID# 250935	West Chester	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  Hungary,  Israel,  Italy,  Japan,  Poland,  Puerto Rico,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 56 Weeks
Primary	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.	Up to 52 Weeks
Primary	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).	Up to 52 Weeks
Primary	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.	Up to 52 Weeks
Primary	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).	Up to 52 Weeks
Primary	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.	Up to 52 Weeks
Primary	Change from Baseline in Tanner Staging Score	Tanner's staging is used to assess growth and pubertal development.	Baseline (Week 0) through Week 52
Primary	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	Baseline (Week 0) through Week 52

External Links

•   Related Info