Study to Assess Adverse Events and Disease Activity of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescents (Ages 6-17) (NCT05125302)
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Single-attack Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6-17)
🩺 Plain-English Summary (8th-Grade Level)
Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. Migraine is extremely common and disabling in children. The purpose of this study is to evaluate how safe and effective ubrogepant is in the acute treatment of migraine in children and adolescents. Ubrogepant is a drug approved for the acute treatment of migraine in adults. Children and adolescents (aged 6-17 years) with a history of migraine will be enrolled. The study will include 2 cohorts of participants - PK Cohort and Main Study (non-PK cohort). Participants aged 6-11 years in the PK Cohort will receive Dose A or Dose B of Ubrogepant for PK analysis to determine dose selection for the main study. In the main study, after dose selection, children aged 6-11 years will be randomized to receive either low or high dose of Ubrogepant or placebo. There is a 1 in 3 chance that a participant will be assigned to placebo. Adolescents aged 12-17 years will be randomized to receive either low or high dose of Ubrogepant or placebo with a 1 in 3 chance of placebo assignment. For qualifying migraine attacks, participants will receive oral tablets of the double-blind study intervention. There will be an option to take a second dose of double-blind study intervention (identical to initial dose), or rescue medication, at least 2 hours after the initial dose, for headache of moderate/severe intensity. Around 1059 participants will be enrolled in the study in approximately 120 sites in the United States. The study duration will be up to 6 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Who can join: Review the eligibility criteria below.
Location: Rehabilitation & Neurological Services /ID# 229969 — Huntsville, Alabama
Age range: 6 Years to 17 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (126 Sites)
Showing the first 25 of 126 sites.
- Rehabilitation & Neurological Services /ID# 229969 — Huntsville, Alabama
- The Center for Clinical Trials - Saraland /ID# 231546 — Saraland, Alabama
- Velocity Clinical Research - Phoenix /ID# 274478 — Phoenix, Arizona
- HealthStar Research Glenwood /ID# 275303 — Glenwood, Arkansas
- HealthStar Research of Hot Springs /ID# 273256 — Hot Springs, Arkansas
- Preferred Research Partners /ID# 230725 — Little Rock, Arkansas
- Advanced Research Center /ID# 227962 — Anaheim, California
- Neuro Pain Research Center /ID# 227966 — Fresno, California
- Alliance for Research Alliance for Wellness /ID# 230546 — Long Beach, California
- Children's Hospital Los Angeles /ID# 230596 — Los Angeles, California
- Excell Research, Inc /ID# 230899 — Oceanside, California
- Paradigm Clinical Research - San Diego /ID# 269608 — San Diego, California
- Lumos Clinical Research Center /ID# 231267 — San Jose, California
- Pacific Clinical Research Management Group /ID# 231636 — Upland, California
- Sunwise Clinical Research /ID# 230971 — Walnut Creek, California
- Amicis Research Center /ID# 272621 — Winnetka, California
- Children's Hospital Colorado - Aurora /ID# 231879 — Aurora, Colorado
- IMMUNOe Research Centers /ID# 230879 — Centennial, Colorado
- MCB Clinical Research Centers - Colorado Springs - South Parkside Drive /ID# 231625 — Colorado Springs, Colorado
- New England Institute for Clinical Research /ID# 230635 — Stamford, Connecticut
- Emerson Clinical Research Institute - Connecticut Avenue - Washington /ID# 231693 — Washington D.C., District of Columbia
- Encore Medical Research of Boynton Beach LLC /ID# 246833 — Boynton Beach, Florida
- Gulf Coast Clinical Research Center /ID# 230020 — Fort Myers, Florida
- Sarkis Clinical Trials /ID# 227956 — Gainesville, Florida
- Northwest Florida Clinical Research Group, LLC /ID# 231069 — Gulf Breeze, Florida
📞 Contact the Study Coordinator
Phone: (844) 663-3742
Email: abbvieclinicaltrials@abbvie.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Migraine
- A Study of Wearable Devices to Predict Migraines — Rochester, Minnesota
- Treatment for Migraine and Mood — The Bronx, New York
- Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine — Birmingham, Alabama
- A Study to Evaluate White Matter Hyperintensities in Migraine — Phoenix, Arizona
- Migraine Manager (R01) — Cincinnati, Ohio
- Nerivio Efficacy Under High-Frequency Use — Bridgewater, New Jersey
Explore by condition: All Migraine clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.