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NCT05711394 · ClinicalTrials.gov registry record · Phase 3

A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine

A Phase 3 study of Episodic Migraine, sponsored by AbbVie.

Recruiting
Registry status
Phase 3
Development phase
450
Enrollment target
20
Study locations

NCT05711394 is a Phase 3 study of Episodic Migraine that is actively recruiting participants, run by AbbVie. The registered enrollment target is 450 participants, roughly in line with the 462-participant average among 13 other Episodic Migraine trials with a reported enrollment target. The trial reports 20 study locations across 11 states.

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The verdict

NCT05711394, a Phase 3 study of Episodic Migraine, is actively recruiting participants, sponsored by AbbVie.

RECRUITING
Registry status
Phase 3
Development phase
450 participants
Enrollment target
20
Study locations

Study Summary

A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. A number of treatments are available for adults with migraine but there are limited approved treatments available for pediatric participants. The main goal of the study is to evaluate the safety and efficacy (how well treatment works) of a low-dose and high-dose of atogepant in pediatric participants between the ages of 6 and 17. Atogepant is a medicine currently approved to treat adults with migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of episodic migraine. This is a Phase 3, randomized, double-blind study of atogepant in participants with a history of episodic migraine with an open-label pharmacokinetic substudy. Eligible participants will be randomized into 6 different groups. Participants between the ages of 12 and 17 will be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. Participants between the ages of 6 and 11 will also be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. The specific atogepant doses to be used in participants between the ages of 6 and 11 will be determined after the PK substudy is complete. Around 450 participants will be enrolled in approximately 100 sites worldwide. Placebo, low-dose atogepant, and high-dose atogepant are given as a tablet to take by mouth once a day. At the end of Week 12, participants will either undergo a follow-up visit 4 weeks after last study treatment or join an extension study where they can continue to receive atogepant for another 52 weeks. There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical a

Conditions Studied

Episodic Migraine

Interventions

  • DRUG Atogepant
  • DRUG Placebo-Matching Atogepant

Study Locations (20)

California

  • Advanced Research Center /ID# 251381 - Anaheim
  • Alliance for Research Alliance for Wellness /ID# 248521 - Long Beach
  • Excell Research, Inc /ID# 247532 - Oceanside
  • Lumos Clinical Research Center /ID# 249731 - San Jose
  • Sunwise Clinical Research /ID# 248529 - Walnut Creek

Florida

  • Northwest Florida Clinical Research Group, LLC /ID# 251382 - Gulf Breeze
  • Advanced Research Institute of Miami /ID# 248539 - Homestead
  • My Preferred Research LLC /ID# 249720 - Miami
  • Asclepes Research Centers - Spring Hill /ID# 248525 - Spring Hill

Alabama

  • Rehabilitation & Neurological Services /ID# 248517 - Huntsville
  • The Center for Clinical Trials - Saraland /ID# 271604 - Saraland

Arkansas

  • Preferred Research Partners /ID# 249729 - Little Rock
  • Preferred Research Partners /ID# 270406 - Little Rock

Colorado

  • Advanced Neurosciences Research, LLC /ID# 247592 - Fort Collins

Georgia

  • Coastal Georgia Child Neurology /ID# 249733 - Brunswick

Indiana

  • Deaconess Clinic - Gateway Health Center /ID# 247589 - Newburgh

Kansas

  • College Park Family Care Center Overland Park /ID# 249734 - Overland Park

Trial Details

FieldValue
Enrollment Target 450 participants
Start Date 2023-05-01
Est. Completion 2028-05
Phase Phase 3

Sponsor

AbbVie

526 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05711394

The ClinicalTrials.gov registry entry for NCT05711394 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 462-participant average among 13 other Episodic Migraine trials with a reported enrollment target. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Episodic Migraine appearing as the primary indexed condition, and to 2 interventions - of which Atogepant is the first listed.

NCT05711394 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Florida, Alabama.

Frequently Asked Questions

What is clinical trial NCT05711394 about?

NCT05711394 is a clinical study titled "A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine". A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. A number of treatments are available for adults with migraine but there are limited approved...

What is the current status of trial NCT05711394?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2023-05-01. Estimated completion is 2028-05.

What conditions does trial NCT05711394 study?

This clinical trial studies the following conditions: Episodic Migraine.

What interventions are being tested in trial NCT05711394?

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

Who is sponsoring clinical trial NCT05711394?

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

Where is trial NCT05711394 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Florida. 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.