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Search / Trial NCT05707949

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

Migraine Prophylaxis Atogepant Qulipta Agn 241689

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.

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

0 patients applied

Trial Officials

ABBVIE INC.

Study Director

AbbVie

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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