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CGRP Antagonist

Atogepant for Pediatric Migraine (Kaleidoscope Trial)

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
Pivotal Trial
No Placebo-Only Group

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.
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.
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 2023 Phase 4 trial • 263 Patients • NCT05264129
9%
COVID-19
6%
NAUSEA
6%
FATIGUE
6%
DECREASED APPETITE
5%
CONSTIPATION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atogepant 60 mg (Period 1)
Atogepant 60 mg + Ubrogepant 100 mg (Period 2)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,035 Previous Clinical Trials
522,401 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
456 Previous Clinical Trials
163,050 Total Patients Enrolled

Media Library

Atogepant (CGRP Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05707949 — Phase 3
Migraine Headaches Research Study Groups: Atogepant Dose A (12-17 yrs), Atogepant Dose B (6-11 yrs)
Migraine Headaches 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
~433 spots leftby Nov 2029
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