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Evaluating Ubrogepant for treating migraines in children and adolescents

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)

Phase 3 Interventional AbbVie · NCT05125302

This study is testing if ubrogepant can safely help kids and teens aged 6-17 with migraines and to find out the best dose for them.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1059 (estimated)
Ages6 Years to 17 Years
SexAll
SponsorAbbVie Industry-sponsored
Locations124 sites (Huntsville, Alabama and 123 other locations)
Trial IDNCT05125302 on ClinicalTrials.gov

What this trial studies

This study assesses the safety and effectiveness of ubrogepant, a medication approved for adult migraine treatment, in children and adolescents aged 6-17. Participants will be divided into two cohorts: a pharmacokinetic (PK) cohort for dose analysis and a main study cohort where they will receive either ubrogepant or a placebo. The main study will randomize participants aged 6-11 years to receive either a low or high dose of ubrogepant or a placebo, following a screening period that includes a single-blind placebo treatment. The goal is to determine the optimal dosage and evaluate the drug's impact on migraine symptoms in this younger population.

Who should consider this trial

Good fit: Ideal candidates are children and adolescents aged 6-17 with a history of migraine lasting between 3 and 72 hours.

Not a fit: Patients who do not have a history of migraines or those who have not responded to previous migraine treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for managing migraines in children and adolescents.

How similar studies have performed: Other studies have shown success with similar approaches in treating migraines in adults, but this specific application in children is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

Huntsville, Alabama and 123 other locations

+74 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions MigraineUbrogepantUbrelvyPERISCOPE
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.