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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 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Ubrogepant
- DRUG Placebo-Matching Ubrogepant
Study Locations (20)
California
- Advanced Research Center /ID# 227962 — Anaheim
- Neuro Pain Research Center /ID# 227966 — Fresno
- Alliance for Research Alliance for Wellness /ID# 230546 — Long Beach
- Children's Hospital Los Angeles /ID# 230596 — Los Angeles
- Excell Research, Inc /ID# 230899 — Oceanside
- Paradigm Clinical Research - San Diego /ID# 269608 — San Diego
- Lumos Clinical Research Center /ID# 231267 — San Jose
- Pacific Clinical Research Management Group /ID# 231636 — Upland
- Sunwise Clinical Research /ID# 230971 — Walnut Creek
- Amicis Research Center /ID# 272621 — Winnetka
Arkansas
- HealthStar Research Glenwood /ID# 275303 — Glenwood
- HealthStar Research of Hot Springs PLLC /ID# 273256 — Hot Springs
- Preferred Research Partners /ID# 230725 — Little Rock
Colorado
- Children's Hospital Colorado - Aurora /ID# 231879 — Aurora
- IMMUNOe Research Centers /ID# 230879 — Centennial
- MCB Clinical Research Centers /ID# 231625 — Colorado Springs
Alabama
- Rehabilitation & Neurological Services /ID# 229969 — Huntsville
- The Center for Clinical Trials - Saraland /ID# 231546 — Saraland
Arizona
- Velocity Clinical Research - Phoenix /ID# 274478 — Phoenix
Connecticut
- New England Institute for Clinical Research /ID# 230635 — Stamford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,059 participants |
| Start Date | 2022-01-13 |
| Est. Completion | 2026-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05125302
The ClinicalTrials.gov registry entry for NCT05125302 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,059 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Migraine appearing as the primary indexed condition, and to 2 interventions — of which Ubrogepant is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05125302 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Arkansas, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05125302 about?
NCT05125302 is a clinical study titled "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)". 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 sa...
What is the current status of trial NCT05125302?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,059 participants. The study started on 2022-01-13. Estimated completion is 2026-05.
What conditions does trial NCT05125302 study?
This clinical trial studies the following conditions: Migraine. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05125302?
The interventions under investigation include: Ubrogepant (DRUG), Placebo-Matching Ubrogepant (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05125302?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05125302 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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