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Search / Trial NCT05127954

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 22, 2025

Enrolling by invitation

Keywords

Migraine Ubrogepant Ubrelvy

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.

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

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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