Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Pediatric Participants (Ages 6-17)
Launched by ABBVIE · Nov 9, 2021
Trial Information
Current as of July 25, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Completers of the lead-in Study 3110-305-002 (in the main study or PK cohort) or those who screen failed due to being placebo responders.
- • Demonstrated an acceptable degree of compliance with study procedures in the lead-in study and who, in the investigator's clinical judgment, did not experience an AE that may indicate an unacceptable safety risk for this study.
- Exclusion Criteria:
- • Requirement for any medication (eg, barbiturates) or diet (eg, grapefruit juice) that is on the list of prohibited concomitant medications that cannot be discontinued or switched to an allowable, alternative medication at Visit 1.
- • An ECG with clinically significant abnormalities at Visit 1 as determined by the investigator.
- • Clinically significant abnormalities in physical examination at Visit 1, as determined by the investigator.
- • Significant risk of self-harm, based on clinical interview and responses on the C-SSRS, or of harm to others in the opinion of the investigator; participants should be excluded if they report suicidal ideation with intent, with or without a plan (ie, Type 4 or 5 on the C-SSRS), or report suicidal behavior at Visit 1
- • Any medical or other reason (eg, unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study) that, in the investigator's opinion, might indicate that the participant is unsuitable for the study.
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
Saraland, Alabama, United States
Little Rock, Arkansas, United States
Little Rock, Arkansas, United States
Anaheim, California, United States
Fresno, California, United States
Lafayette, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Oceanside, California, United States
San Diego, California, United States
San Jose, California, United States
Upland, California, United States
Aurora, Colorado, United States
Centennial, Colorado, United States
Colorado Springs, Colorado, United States
Washington, District Of Columbia, United States
Boynton Beach, Florida, United States
Fort Myers, Florida, United States
Gainesville, Florida, United States
Gulf Breeze, Florida, United States
Hialeah, Florida, United States
Hollywood, Florida, United States
Homestead, Florida, United States
Lakeland, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Orange City, Florida, United States
Pembroke Pines, Florida, United States
Pembroke Pines, Florida, United States
Spring Hill, Florida, United States
Tampa, Florida, United States
Weston, Florida, United States
Winter Park, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Brunswick, Georgia, United States
Decatur, Georgia, United States
Savannah, Georgia, United States
Stockbridge, Georgia, United States
Meridian, Idaho, United States
Ames, Iowa, United States
Overland Park, Kansas, United States
Overland Park, Kansas, United States
Wichita, Kansas, United States
Lexington, Kentucky, United States
Baltimore, Maryland, United States
Bloomfield Hills, Michigan, United States
Burnsville, Minnesota, United States
Petal, Mississippi, United States
Ridgeland, Mississippi, United States
Ozark, Missouri, United States
Papillion, Nebraska, United States
Nashua, New Hampshire, United States
Annandale, New Jersey, United States
Morristown, New Jersey, United States
Runnemede, New Jersey, United States
Amherst, New York, United States
Mount Kisco, New York, United States
Port Jefferson Station, New York, United States
Syracuse, New York, United States
Charlotte, North Carolina, United States
Hickory, North Carolina, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
West Chester, Ohio, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Scottdale, Pennsylvania, United States
Smithfield, Pennsylvania, United States
Charleston, South Carolina, United States
Greenville, South Carolina, United States
Greer, South Carolina, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Austin, Texas, United States
Beaumont, Texas, United States
Cedar Park, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
El Paso, Texas, United States
Friendswood, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Kerrville, Texas, United States
Lampasas, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
The Woodlands, Texas, United States
Waxahachie, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
Woodstock, Vermont, United States
Franklin, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Everett, Washington, United States
Kingwood, West Virginia, United States
Ames, Iowa, United States
Los Angeles, California, United States
Dorado, , Puerto Rico
San Juan, , Puerto Rico
Germantown, Tennessee, United States
Ponce, , Puerto Rico
Bountiful, Utah, United States
Cincinnati, Ohio, United States
Mansfield, Texas, United States
Charleston, South Carolina, United States
Long Beach, California, United States
Upland, California, United States
Aurora, Colorado, United States
Fort Myers, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Tampa, Florida, United States
Weston, Florida, United States
Winter Park, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Chicago, Illinois, United States
Ridgeland, Mississippi, United States
New York, New York, United States
Columbus, Ohio, United States
Austin, Texas, United States
Salt Lake City, Utah, United States
San Juan, , Puerto Rico
Fresno, California, United States
San Diego, California, United States
Walnut Creek, California, United States
Stamford, Connecticut, United States
Hollywood, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Palm Harbor, Florida, United States
Winter Park, Florida, United States
Savannah, Georgia, United States
Ames, Iowa, United States
Overland Park, Kansas, United States
Amherst, New York, United States
Portland, Oregon, United States
Smithfield, Pennsylvania, United States
Greer, South Carolina, United States
Austin, Texas, United States
Mequon, Wisconsin, United States
Bayamon, , Puerto Rico
San Juan, , Puerto Rico
Patients applied
Trial Officials
ABBVIE INC.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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