A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine
Launched by ABBVIE · Jan 26, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called atogepant to see how safe and effective it is for treating episodic migraines in children aged 6 to 17. Migraines are severe headaches that can cause other symptoms like nausea and sensitivity to light. Currently, there are limited treatment options for kids, so this study aims to find out if atogepant can help them. Participants will take either a low dose, a high dose, or a placebo (a tablet with no active medication) once a day for 12 weeks. The study will also include regular check-ups to monitor their health and any side effects.
To be eligible for the trial, participants need to weigh between 44 and 298 pounds and have a history of episodic migraines for at least six months, with 4 to 14 migraine days in the past month. They will need to attend visits at a hospital or clinic for assessments, blood tests, and questionnaires about their migraines. Around 450 participants will be involved at various sites worldwide. After the 12 weeks, participants can either return for a follow-up visit or join a longer study to continue receiving atogepant for another year.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Weight is \>= 20 kg (44 lbs) and \< 135 kg (298 lbs).
- • History of episodic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD) -3 (2018) for at least 6 months.
- • Participant has to have 4 to 14 migraine days and \< 15 headache days in the 28-day baseline period per eDiary.
- • To be eligible for the PK substudy, participants must be 6 to 11 years of age (inclusive), with a history of migraine (consistent with a diagnosis according to the ICHD-3 \[2018\]) and per investigator judgment is appropriate to receive preventive treatment for migraine.
- Exclusion Criteria:
- • History of migraine brainstem aura, 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 daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018).
About Abbvie
AbbVie is a global biopharmaceutical company dedicated to developing innovative therapies that address complex health challenges. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie focuses on key therapeutic areas, including immunology, oncology, neuroscience, and virology. The company is committed to advancing scientific research and delivering groundbreaking treatments that enhance patient outcomes and quality of life. With a robust pipeline and a strong emphasis on collaboration, AbbVie strives to transform the future of medicine through its commitment to clinical excellence and patient-centered approaches.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Huntsville, Alabama, United States
Little Rock, Arkansas, United States
Anaheim, California, United States
Lafayette, California, United States
Long Beach, California, United States
Oceanside, California, United States
San Jose, California, United States
Centennial, Colorado, United States
Colorado Springs, Colorado, United States
Fort Collins, Colorado, United States
Gainesville, Florida, United States
Gulf Breeze, Florida, United States
Homestead, Florida, United States
Miami, Florida, United States
Spring Hill, Florida, United States
Brunswick, Georgia, United States
Stockbridge, Georgia, United States
Boise, Idaho, United States
Newburgh, Indiana, United States
Overland Park, Kansas, United States
Ann Arbor, Michigan, United States
Springfield, Missouri, United States
Papillion, Nebraska, United States
Morristown, New Jersey, United States
Amherst, New York, United States
Mount Kisco, New York, United States
Greensboro, North Carolina, United States
Cincinnati, Ohio, United States
West Chester, Ohio, United States
Oklahoma City, Oklahoma, United States
Nashville, Tennessee, United States
Austin, Texas, United States
El Paso, Texas, United States
Friendswood, Texas, United States
The Woodlands, Texas, United States
Waxahachie, Texas, United States
Bountiful, Utah, United States
Salt Lake City, Utah, United States
Woodstock, Vermont, United States
Franklin, Virginia, United States
Everett, Washington, United States
Edegem, Antwerpen, Belgium
Brugge, , Belgium
Edmonton, Alberta, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Herning, Midtjylland, Denmark
Aalborg, Nordjylland, Denmark
Herlev, , Denmark
Amiens Cedex 1, Somme, France
Creteil, Val De Marne, France
Toulouse Cedex 9, , France
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Ramat Gan, Tel Aviv, Israel
Tel Aviv Yafo, Tel Aviv, Israel
Hadera, , Israel
Haifa, , Israel
Rome, Lazio, Italy
Milan, , Italy
Palermo, , Italy
Amsterdam, , Netherlands
Den Haag, , Netherlands
Terneuzen, , Netherlands
Lublin, Lubelskie, Poland
Krakow, Malopolskie, Poland
Poznan, Wielkopolskie, Poland
Bydgoszcz, , Poland
Warszawa, , Poland
Wroclaw, , Poland
Dorado, , Puerto Rico
San Juan, , Puerto Rico
Bucharest, Bucuresti, Romania
Cluj Napoca, Cluj, Romania
Bucharest, , Romania
Sibiu, , Romania
Barcelona, , Spain
Barcelona, , Spain
Madrid, , Spain
Sevilla, , Spain
Valencia, , Spain
Stockholm, , Sweden
Vanersborg, , Sweden
Aberdeen, , United Kingdom
Gillingham, , United Kingdom
Macclesfield, , United Kingdom
Herlev, Hovedstaden, Denmark
San Juan, , Puerto Rico
Bucharest, , Romania
Vanersborg, , Sweden
Gillingham, Kent, United Kingdom
Miami, Florida, United States
Kobe Shi, Hyogo, Japan
Nishinomiya, Hyogo, Japan
Kochi Shi, Kochi, Japan
Sendai Shi, Miyagi, Japan
Osaka Shi, Osaka, Japan
Shinjuku Ku, Tokyo, Japan
Amsterdam, Noord Holland, Netherlands
Nijmegen, , Netherlands
Poznan, Wielkopolskie, Poland
London, Ontario, Canada
Hadera, H Efa, Israel
Molnlycke, , Sweden
Bydgoszcz, , Poland
Warszawa, Mazowieckie, Poland
Poznan, Wielkopolskie, Poland
Be'er Yaakov, Hamerkaz, Israel
Edmonton, Alberta, Canada
Ridgeland, Mississippi, United States
Kyoto, , Japan
Haifa, H Efa, Israel
Tel Aviv, Tel Aviv, Israel
Lublin, Lubelskie, Poland
Bruges, , Belgium
Oklahoma City, Oklahoma, United States
Stockport, , United Kingdom
New York, New York, United States
Milano, , Italy
Budapest, , Hungary
Bayamon, , Puerto Rico
Beer Ya'akov, Hamerkaz, Israel
Long Beach, California, United States
Herlev, Hovedstaden, Denmark
Kyoto, Fukui, Japan
Den Haag, Zuid Holland, Netherlands
Nijmegen, Zuid Holland, Netherlands
Terneuzen, Zuid Holland, Netherlands
Bydgoszcz, Kujawsko Pomorskie, Poland
Caguas, , Puerto Rico
San Juan, , Puerto Rico
Madrid, , Spain
Stockholm, Sodermanlands Lan, Sweden
London, Ontario, Canada
Aalborg, Nordjylland, Denmark
Palermo, , Italy
Nijmegen, Gelderland, Netherlands
Terneuzen, Zeeland, Netherlands
Stockholm, Stockholms Lan, Sweden
Milan, Milano, Italy
Memphis, Tennessee, United States
Walnut Creek, California, United States
Austin, Texas, United States
Sevilla, , Spain
Amherst, New York, United States
Budapest, , Hungary
Rome, Roma, Italy
Little Rock, Arkansas, United States
Montreal, Quebec, Canada
Patients applied
Trial Officials
ABBVIE INC.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials