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NCT05125302 · ClinicalTrials.gov registry record · Phase 3

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)

A Phase 3 study of Migraine, sponsored by AbbVie.

Recruiting
Registry status
Phase 3
Development phase
1,059
Enrollment target
20
Study locations

NCT05125302 is a Phase 3 study of Migraine that is actively recruiting participants, run by AbbVie. The registered enrollment target is 1,059 participants, above the 348-participant average among 102 other Migraine trials with a reported enrollment target (204% higher). The trial reports 20 study locations across 6 states.

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The verdict

NCT05125302, a Phase 3 study of Migraine, is actively recruiting participants, sponsored by AbbVie.

RECRUITING
Registry status
Phase 3
Development phase
1,059 participants
Enrollment target
20
Study locations

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

Migraine

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

FieldValue
Enrollment Target 1,059 participants
Start Date 2022-01-13
Est. Completion 2026-05
Phase Phase 3

Sponsor

AbbVie

526 total trials

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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, categorized as Phase 3. The registered enrollment target is 1,059 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 348-participant average among 102 other Migraine trials with a reported enrollment target (204% higher). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

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.

NCT05125302 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Arkansas, Colorado.

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.

What interventions are being tested in trial NCT05125302?

The interventions under investigation include: Ubrogepant (DRUG), Placebo-Matching Ubrogepant (DRUG).

Who is sponsoring clinical trial NCT05125302?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.