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CGRP Antagonist

Atogepant for Pediatric Migraine

Phase 3
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 56 weeks
Awards & highlights

Study Summary

This trial will evaluate the long-term safety and tolerability of atogepant in pediatric participants between ages 6-17 with episodic migraine. 250 participants worldwide will receive atogepant for 52 weeks & will attend regular visits to check for side effects.

Who is the study for?
This trial is for kids aged 6-17 with episodic migraines, weighing between 44 and 298 lbs. They must have had migraines for at least six months and experience them on 4 to14 days per month. Participants should have finished a prior study or its screening phase but not met the migraine day count required there.Check my eligibility
What is being tested?
The trial tests Atogepant's long-term safety in children with migraines. It's an open-label Phase 3 study where participants take Atogepant daily for a year. The dosage varies by age: high dose for ages 12-17, and a specific dose determined earlier for ages 6-11.See study design
What are the potential side effects?
While the exact side effects in children are being studied, adults taking Atogepant may experience constipation, nausea, fatigue, and dry mouth. Side effects will be monitored through regular medical check-ups and blood tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 56 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 56 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF 2) questionnaire
Change from Baseline in Tanner Staging Score
Percentage of Participants with Adverse Events (AEs)
+5 more

Side effects data

From 2020 Phase 3 trial • 744 Patients • NCT03700320
10%
Upper respiratory tract infection
7%
Constipation
6%
Nausea
5%
Urinary tract infection
4%
Nasopharyngitis
3%
Fatigue
3%
Dizziness
3%
Anxiety
1%
Paraesthesia
1%
Weight increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atogepant 60 mg
Oral SOC Migraine Preventive Medication

Trial Design

2Treatment groups
Experimental Treatment
Group I: Atogepant Dose B (6-11 yrs)Experimental Treatment1 Intervention
Participants aged 6-11 will receive the highest dose of oral tablets of atogepant tested in the lead-in study M21-201.
Group II: Atogepant Dose A (12-17 yrs)Experimental Treatment1 Intervention
Participant aged 12-17 will receive oral tablets of atogepant Dose A once a day for up to 52 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atogepant
2018
Completed Phase 4
~3490

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
954 Previous Clinical Trials
500,794 Total Patients Enrolled
10 Trials studying Migraine
7,659 Patients Enrolled for Migraine
ABBVIE INC.Study DirectorAbbVie
394 Previous Clinical Trials
145,628 Total Patients Enrolled
10 Trials studying Migraine
7,659 Patients Enrolled for Migraine

Media Library

Atogepant (CGRP Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05707949 — Phase 3
Migraine Research Study Groups: Atogepant Dose A (12-17 yrs), Atogepant Dose B (6-11 yrs)
Migraine Clinical Trial 2023: Atogepant Highlights & Side Effects. Trial Name: NCT05707949 — Phase 3
Atogepant (CGRP Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05707949 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it permissible for individuals under the age of eighteen to join this clinical research?

"This clinical trial's enrollment requirements stipulate that participants are aged between 6 and 17 years old. There are 31 studies available for minors, whereas those over 65 can choose from 106 different options."

Answered by AI

What health hazards are associated with Atogepant Dose A for adolescents in the 12-17 age range?

"There is prior clinical evidence that attests to Atogepant Dose A (12-17 yrs)'s safety, thus it was evaluated as a 3 on our scale."

Answered by AI

Are there any available slots for participants in this clinical trial?

"Clinicaltrials.gov indicates that this investigation is not currently seeking patients, despite having been posted on March 9th 2023 and last updated on January 24th of the same year. However, 155 other research initiatives are actively enrolling participants at present."

Answered by AI

In what geographic areas is this investigation being conducted?

"The recruitment phase of this trial is currently operating in 43 distinct medical centres. Areas close to Huntsville, Little Rock and Anaheim are among those enrolled; other sites exist throughout the United States. To reduce travel burden, it's best to choose a clinic located near you if you're interested in taking part."

Answered by AI

Who meets the criteria to join this medical experiment?

"This clinical trial is aiming to recruit 250 minors aged between 6 and 17 who are suffering from migraine with aura. To be enrolled, participants must meet the following requirements: being between 6-17 years old (inclusive), having a history of episodic migraine, completing Study M21-201 or its PK substudy, weighing at least 20 kg but less than 135kg, presenting a past consistent with ICHD-3 diagnosis for more than half a year and deemed an appropriate candidate by their investigator to receive daily preventive treatment using Atogepant (except in de novo cases)."

Answered by AI
~167 spots leftby Nov 2029