Long-term Extension Study to Assess Adverse Events of Oral Atogepant Tablets in Pediatric Participants (6 to 17 Years of Age) With Migraine
Launched by ABBVIE · Jan 24, 2023
Trial Information
Current as of July 09, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- 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.
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
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
Everett, Washington, United States
Edegem, Antwerpen, Belgium
Brugge, , Belgium
Edmonton, Alberta, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Herlev, Hovedstaden, Denmark
Herning, Midtjylland, Denmark
Aalborg, Nordjylland, 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
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
Gillingham, Kent, United Kingdom
Aberdeen, , United Kingdom
Macclesfield, , United Kingdom
Miami, Florida, United States
Franklin, Virginia, United States
Ridgeland, Mississippi, United States
Hadera, H Efa, Israel
Be'er Yaakov, Hamerkaz, Israel
Kobe Shi, Hyogo, Japan
Sendai Shi, Miyagi, Japan
Osaka Shi, Osaka, Japan
Kyoto, , Japan
Warszawa, Mazowieckie, Poland
Poznan, Wielkopolskie, Poland
Bydgoszcz, , Poland
Molnlycke, , Sweden
Nishinomiya Shi, Hyogo, Japan
Kochi Shi, Kochi, Japan
Shinjuku Ku, Tokyo, Japan
Long Beach, California, United States
New York, New York, United States
Oklahoma City, Oklahoma, United States
Edmonton, Alberta, Canada
Herlev, Hovedstaden, Denmark
Budapest, , Hungary
Haifa, H Efa, Israel
Beer Ya'akov, Hamerkaz, Israel
Tel Aviv, Tel Aviv, Israel
Milano, , Italy
Nijmegen, , Netherlands
Bydgoszcz, Kujawsko Pomorskie, Poland
Bayamon, , Puerto Rico
Caguas, , Puerto Rico
San Juan, , Puerto Rico
Madrid, , Spain
Stockport, , United Kingdom
Patients applied
Trial Officials
ABBVIE INC.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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