Study of Ubrogepant for Migraine in Children and Adolescents
This study is looking at how safe and effective ubrogepant tablets are for treating migraine headaches in children and teenagers aged 6 to 17. Ubrogepant is already approved for adults with migraine. We want to see if it helps children and teens get rid of their migraine pain within two hours of taking the medicine. You can join if you have a history of migraine for at least six months, and your migraines typically last between 3 and 72 hours if not treated. The study plans to enroll 1059 participants. The current status of this study is unclear.
- Study design
- This is an interventional study involving 1059 planned participants aged 6 to 17 years. Participants will receive either ubrogepant or a placebo-matching ubrogepant oral tablet.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint measures pain freedom at 2 hours after the initial dose.
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NCT05125302
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)
Recruiting
PHASE3Ages 6–17InterventionalTreatmentAbbVie
~1,059 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:UbrogepantPlacebo-Matching Ubrogepant
At a glance
Recruiting sites
88 of 126 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years
Measured over 2 hours after initial dose
Conditions
Where it's being run
126 sites across 37 statesTexas22
Florida18
California10
Georgia7
Ohio6
New York5
Kansas4
Virginia4
Study leadership
- ABBVIE INC. · STUDY_DIRECTOR · AbbVie
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
A history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD-3) for at least 6 months.
By history, the participant's migraines typically last between 3 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom.
History of 1 to 14 migraine attacks per month with moderate to severe headache in each of the 2 months prior to screening (Visit 1).
Current or past use of at least 1 oral medication (over-the-counter medication or prescription medication) for the acute treatment of migraine.
For main study participants, treatment of a qualifying migraine with single-blind placebo during the screening period and completion of 2-hour headache pain assessment.
Weight is ≥ 20 kg (44 pounds) and \< 135 kg (298 pounds)
Per investigator judgment, participant is able to swallow or can learn to swallow study intervention.
The participant is able to understand and complete the study questionnaires and eDiary. Participants who need assistance with reading the assessments may be assisted by a parent or guardian.
Exclusion
Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease.
In the opinion of the investigator, other confounding pain syndromes, confounding psychiatric conditions, or other significant neurological disorders other than migraine.
History of malignancy in the 5 years prior to Visit 1.
History of any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of the study intervention.
Significant risk of self-harm, based on clinical interview and responses on the Columbia-Suicide Severity Rating Scale (C-SSRS), or of harm to others; participants must be excluded if they report suicidal ideation with intent, with or without a plan, (ie, Type 4 or 5 on the C-SSRS) in the past 6 months or report suicidal behavior in the last 6 months prior to Visit 1 or Visit 2 assessments.
At Visit 1, current alcohol or drug abuse or dependence per investigator's judgment.
For main study participants, no headache at the 2-hour post dose assessment after taking single-blind placebo for a qualifying migraine during screening period (ie, placebo responder).
A current diagnosis of chronic migraine as defined by ICHD-3
Participants who overuse medication for migraine defined as use of opioids or barbiturates \> 2 days/month, triptans or ergots ≥ 10 days/month, simple analgesics (eg, aspirin, NSAIDs, acetaminophen) ≥ 15 days/month or any combination of triptans, ergots, or simple analgesics (eg, aspirin, NSAIDs, acetaminophen) ≥ 10 days/month in the 3 months prior to Visit 1 per investigator's judgment.
Difficulty distinguishing migraine headache from tension-type or other headaches.
Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3.
Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3
Required in-hospital (excluding emergency department visits) treatment for migraines 3 or more times in the 6 months prior to Visit 1.
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.
Previous exposure, within the last 6 months, to injectable monoclonal antibodies blocking the calcitonin gene-related peptide (CGRP) pathway
History of hypersensitivity or clinically significant adverse reaction to a CGRP receptor antagonist or hypersensitivity to any component of the study interventions, ubrogepant or placebo.
Currently participating or has participated in a study with an investigational compound or device within 30 days prior to Visit 1
What this trial measures
- Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years2 hours after initial dose
Pain Freedom is defined as a reduction in headache severity from moderate/severe at baseline to no pain.