Long-term Extension Study to Assess Adverse Events of Oral Atogepant Tablets in Pediatric Participants (6 to 17 Years of Age) With Migraine
- 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
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 650
- 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.
- 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (86)
My Preferred Research LLC /ID# 250931
🇺🇸Miami, Florida, United States
Patient Priority Clinical Sites, LLC /ID# 250922
🇺🇸Cincinnati, Ohio, United States
Access Clinical Trials, Inc. /ID# 250914
🇺🇸Nashville, Tennessee, United States
Highland Clinical Research /ID# 250924
🇺🇸Salt Lake City, Utah, United States
Advanced Neurosciences Research, LLC /ID# 250925
🇺🇸Fort Collins, Colorado, United States
College Park Family Care Center Overland Park /ID# 251609
🇺🇸Overland Park, Kansas, United States
Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 249184
🇮🇹Palermo, Italy
Specjalistyczne Gabinety Sp. z o.o. /ID# 250625
🇵🇱Krakow, Malopolskie, Poland
Caribbean Medical Research Center /ID# 253156
🇵🇷San Juan, Puerto Rico
Delta Health Care S.R.L /ID# 250996
🇷🇴Bucharest, Romania
Semmelweis Egyetem /ID# 251593
ðŸ‡ðŸ‡ºBudapest, Hungary
Bnai Zion Medical Center /ID# 251132
🇮🇱Haifa, H_efa, Israel
ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 250603
🇳🇱Terneuzen, Netherlands
Athleticomed Sp. z o.o /ID# 250620
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Goryeb Children's Hospital /ID# 250934
🇺🇸Morristown, New Jersey, United States
Montreal Children's Hospital /ID# 250649
🇨🇦Montreal, Quebec, Canada
Shamir Medical Center /ID# 256858
🇮🇱Beer Ya'akov, HaMerkaz, Israel
The Chaim Sheba Medical Center /ID# 248990
🇮🇱Ramat Gan, Tel-Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 251133
🇮🇱Tel Aviv, Tel-Aviv, Israel
Umenotsuji Clinic /ID# 254454
🇯🇵Kochi-shi, Kochi, Japan
HagaZiekenhuis /ID# 251655
🇳🇱Den Haag, Netherlands
Spitalul Clinic de Copii Dr. Victor Gomoiu /ID# 250997
🇷🇴Bucharest, Bucuresti, Romania
Cognitive Clinical Trials (CCT) - Papillion /ID# 251610
🇺🇸Papillion, Nebraska, United States
Mind Klinika Kft. /ID# 251597
ðŸ‡ðŸ‡ºBudapest, Hungary
CHU Amiens-Picardie Site Sud /ID# 251377
🇫🇷Amiens CEDEX 1, Somme, France
Centre Hosp Intercommunal de Creteil /ID# 251199
🇫🇷Creteil, Val-de-Marne, France
Hillel Yaffe Medical Center /ID# 248923
🇮🇱Hadera, H_efa, Israel
Tominaga Clinic /ID# 254451
🇯🇵Osaka-shi, Osaka, Japan
Tatsuoka Neurology Clinic /ID# 254456
🇯🇵Kyoto, Japan
Canisius-Wilhelmina Ziekenhuis /ID# 253067
🇳🇱Nijmegen, Netherlands
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 250622
🇵🇱Lublin, Lubelskie, Poland
OHA-MED sp. z o.o /ID# 250621
🇵🇱Warszawa, Mazowieckie, Poland
Clinical Research Investigator Group, LLC /ID# 261251
🇵🇷Bayamon, Puerto Rico
Proven Endpoints LLC /ID# 258083
🇺🇸Ridgeland, Mississippi, United States
Stollery Children's Hospital /ID# 251426
🇨🇦Edmonton, Alberta, Canada
Uza /Id# 247885
🇧🇪Edegem, Antwerpen, Belgium
AZ Sint-Jan Brugge /ID# 247527
🇧🇪Brugge, Belgium
Sendai Headache and Neurology Clinic Medical Corporation /ID# 254212
🇯🇵Sendai-shi, Miyagi, Japan
Spitalul Clinic de Urgenta pentru Copii Cluj Napoca /ID# 251112
🇷🇴Cluj-Napoca, Cluj, Romania
Clinical Research Center Sp. z.o.o. Medic-R sp. k /ID# 250623
🇵🇱Poznan, Wielkopolskie, Poland
Puerto Rico Health Institute /ID# 250949
🇵🇷Dorado, Puerto Rico
Michigan Headache & Neurological Institute (MHNI) /ID# 250920
🇺🇸Ann Arbor, Michigan, United States
Preferred Research Partners /ID# 250937
🇺🇸Little Rock, Arkansas, United States
Advanced Research Center /ID# 251616
🇺🇸Anaheim, California, United States
Rehabilitation & Neurological Services /ID# 250910
🇺🇸Huntsville, Alabama, United States
Sunwise Clinical Research /ID# 250913
🇺🇸Lafayette, California, United States
Lumos Clinical Research Center /ID# 251608
🇺🇸San Jose, California, United States
Excell Research, Inc /ID# 251611
🇺🇸Oceanside, California, 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
Asclepes Research Centers - Spring Hill /ID# 250912
🇺🇸Spring Hill, Florida, United States
Coastal Georgia Child Neurology /ID# 250938
🇺🇸Brunswick, Georgia, United States
Deaconess Clinic - Gateway Health Center /ID# 250923
🇺🇸Newburgh, Indiana, United States
Dent Neurosciences Research Center, Inc. /ID# 250915
🇺🇸Amherst, New York, United States
Modern Migraine MD /ID# 258082
🇺🇸New York, New York, United States
Headache Wellness Center /ID# 251612
🇺🇸Greensboro, North Carolina, United States
CincyScience /ID# 250935
🇺🇸West Chester, Ohio, United States
3A Research - East El Paso /ID# 250909
🇺🇸El Paso, Texas, United States
Lynn Institute of Oklahoma City /ID# 250926
🇺🇸Oklahoma City, Oklahoma, United States
FutureSearch Trials of Neurology /ID# 251613
🇺🇸Austin, Texas, United States
Earle Research /ID# 250908
🇺🇸Friendswood, Texas, United States
ClinPoint Trials /ID# 250942
🇺🇸Waxahachie, Texas, United States
Family Psychiatry of The Woodlands /ID# 250936
🇺🇸The Woodlands, Texas, United States
Pantheon Clinical Research /ID# 251615
🇺🇸Bountiful, Utah, United States
Core Clinical Research /ID# 250932
🇺🇸Everett, Washington, United States
Office of Maria Ona /ID# 250939
🇺🇸Franklin, Virginia, United States
Herlev Hospital /ID# 247725
🇩🇰Herlev, Hovedstaden, Denmark
Regionshospitalet Godstrup /ID# 247903
🇩🇰Herning, Midtjylland, Denmark
Aalborg Universitetshospital /Id# 247429
🇩🇰Aalborg, Nordjylland, Denmark
CHU Toulouse - Hôpital des enfants /ID# 251201
🇫🇷Toulouse CEDEX 9, France
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 249182
🇮🇹Milano, Italy
Yamaguchi Clinic /ID# 254763
🇯🇵Nishinomiya-shi, Hyogo, Japan
Konan Medical Center /ID# 254458
🇯🇵Kobe-shi, Hyogo, Japan
Tokyo Medical University Hospital /ID# 254460
🇯🇵Shinjuku-ku, Tokyo, Japan
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 250624
🇵🇱Wroclaw, Poland
Dr. Samuel Sanchez PSC /ID# 261670
🇵🇷Caguas, Puerto Rico
PRCCI Clinical Research Center /ID# 264232
🇵🇷San Juan, Puerto Rico
Hospital Universitario Vall d'Hebron /ID# 248457
🇪🇸Barcelona, Spain
Hospital Universitario Virgen del Rocio /ID# 248633
🇪🇸Sevilla, Spain
Vastra Gotealandsregionen Regionhalsan /ID# 248981
🇸🇪Molnlycke, Sweden
Hospital Universitario y Politecnico La Fe /ID# 248459
🇪🇸Valencia, Spain
Sodersjukhuset /ID# 250671
🇸🇪Stockholm, Sweden
NHS Grampian /ID# 251474
🇬🇧Aberdeen, United Kingdom
Stockport NHS foundation trust /ID# 261562
🇬🇧Stockport, United Kingdom
Alliance for Research Alliance for Wellness /ID# 250911
🇺🇸Long Beach, California, United States
Hospital Clinico San Carlos /ID# 249268
🇪🇸Madrid, Spain