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Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist
Atogepant for Migraine
Little Rock, AR
Phase 3
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* History of chronic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) (2018) for at least 6 months as of Visit 1.
* Participant has \>= 15 headache days.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 16 weeks
Awards & highlights
Pivotal Trial
Summary
This trial aims to study a new medication called atogepant for preventing chronic migraine in adolescents aged 12 to 17 years. The study will compare the effectiveness of atogepant to a
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Who is the study for?
This trial is for young people aged 12 to 17 with chronic migraine, experiencing at least 8 migraine days and a minimum of 15 headache days. They must have had migraines for at least six months and be able to complete an electronic diary regularly.Check my eligibility
What is being tested?
The study tests Atogepant tablets against a placebo in preventing migraines. It's double-blinded, so neither participants nor doctors know who gets the real medicine or placebo. The treatment lasts for 12 weeks with follow-up after four weeks.See study design
What are the potential side effects?
Possible side effects include reactions typical of migraine medications such as nausea, fatigue, dry mouth, and digestive issues. Since it's a blinded study, exact side effects will be monitored through diaries and medical assessments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with chronic migraines for at least 6 months.
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I experience 15 or more headache days a month.
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I experience 8 or more migraine days a month.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 16 weeks
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 Mean Monthly Migraine Days
Number of Participants Experiencing Adverse Events (AEs)
Secondary study objectives
Change From Baseline in Mean Monthly Acute Medication Use Days
Change From Baseline in Mean Monthly Headache Days
Change From Baseline in the Pediatric Migraine Disability Assessment (PedMIDAS) Total Score
+2 moreSide effects data
From 2023 Phase 4 trial • 263 Patients • NCT052641293%
COVID-19
1%
FATIGUE
1%
DECREASED APPETITE
1%
CONSTIPATION
1%
NAUSEA
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atogepant 60 mg + Ubrogepant 100 mg (Period 2)
Atogepant 60 mg (Period 1)
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AtogepantExperimental Treatment1 Intervention
Participants will receive atogepant once daily for 12 weeks.
Group II: Placebo for AtogepantPlacebo Group1 Intervention
Participants will receive placebo for atogepant once daily for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atogepant
2018
Completed Phase 4
~3490
Find a Location
Closest Location:Preferred Research Partners /ID# 270389· Little Rock, AR
Who is running the clinical trial?
AbbVieLead Sponsor
1,070 Previous Clinical Trials
532,108 Total Patients Enrolled
14 Trials studying Migraine
12,263 Patients Enrolled for Migraine
ABBVIE INC.Study DirectorAbbVie
484 Previous Clinical Trials
170,037 Total Patients Enrolled
14 Trials studying Migraine
12,263 Patients Enrolled for Migraine