Evidence map›Paper›PMID 39715475›Full record

Trial reportNeurology2025

Early Improvements With Atogepant for the Preventive Treatment of Migraine: Results From 3 Randomized Phase 3 Trials.

Richard B Lipton, Pranav Gandhi, Cristina Tassorelli, Uwe Reuter, Andrea M Harriott, Dagny Holle-Lee, Christopher H Gottschalk, Brian Neel, Yingyi Liu, Hua Guo and 4 more

3 registry-linked trialsAbstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Neurology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03777059 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine (ADVANCE)

TypeinterventionalSponsorAllerganRan2018 to 2020Enrolled910ConditionsEpisodic MigraineArmsAtogepant, Placebo
NCT03855137 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine (Progress)

TypeinterventionalSponsorAllerganRan2019 to 2022Enrolled778ConditionsChronic MigraineArmsAtogepant 30 mg, Atogepant 60 mg, Placebo
NCT04740827 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prophylaxis of Migraine in Participants With Episodic Migraine Who Have Previously Failed 2 to 4 Classes of Oral Prophylactic Treatments (ELEVATE)

TypeinterventionalSponsorAllerganRan2021 to 2022Enrolled315ConditionsEpisodic MigraineArmsAtogepant 60 mg, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Richard B LiptonDepartment of Neurology and Headache Center, Albert Einstein College of Medicine, Bronx, NY.ORCID 0000-0003-2652-2897
Pranav GandhiAbbVie, Madison, NJ.ORCID 0009-0008-8317-7712
Cristina TassorelliDepartment of Brain and Behavioral Sciences, University of Pavia, Italy.ORCID 0000-0003-1513-2113
Uwe ReuterDepartment of Neurology and West German Headache Center, University Hospital Essen, Germany.ORCID 0000-0002-8527-0725
Andrea M HarriottMassachusetts General Hospital, Boston, MA.ORCID 0000-0003-0417-7586
Dagny Holle-LeeCharité University Hospital of Berlin, Germany.ORCID 0000-0003-4872-0384
Christopher H GottschalkDivision of General Neurology, Yale School of Medicine, New Haven, CT.ORCID 0000-0002-1105-6910
Brian NeelAbbVie, Irvine, CA.ORCID 0000-0001-8269-3717
Yingyi LiuAbbVie, North Chicago, IL; and.ORCID 0009-0002-5243-0793
Hua GuoAbbVie, Madison, NJ.ORCID 0009-0007-4534-6100
Jonathan StokesAbbVie, Madison, NJ.ORCID 0009-0004-3707-6225
Krisztian NagyAbbVie, Budapest, Hungary.ORCID 0009-0007-8698-941X
Brett DabruzzoAbbVie, Madison, NJ.ORCID 0009-0008-3048-2633
Jonathan H SmithAbbVie, North Chicago, IL; and.ORCID 0000-0002-2798-6805

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Sex Differences in the Role of Gonadal Hormones and the Hypothalamus in Migraine with Aura.K08NS124991 · NINDS · MASSACHUSETTS GENERAL HOSPITAL · PI Andrea M Harriott · 2022 to 2026
$1.1M
NCATS NIH HHS UL1 TR001863NINDS NIH HHS K08 NS124991
6 · The paper itself

Abstract

BACKGROUND AND

objectivesThree phase 3 trials demonstrated the efficacy and safety of atogepant in episodic migraine (EM) and chronic migraine (CM) across 12-week treatment periods. This analysis evaluates improvements in efficacy and functional outcomes in the first 4 weeks of treatment with the oral calcitonin gene-related peptide receptor antagonist, atogepant, for the preventive treatment of migraine.

methodsADVANCE, ELEVATE, and PROGRESS were phase 3, multicenter, randomized, double-blind, placebo-controlled 12-week trials. ADVANCE and ELEVATE included participants aged 18-80 years with >1 year history of EM and 4-14 monthly migraine days (MMDs). ELEVATE required previous treatment failures to 2-4 classes of oral preventives. PROGRESS included participants aged 18-80 years with >1 year history of CM, ≥15 monthly headache days, and ≥8 MMDs. This analysis reports the atogepant 60 mg once daily (QD) and placebo treatment arms. Outcomes included efficacy endpoints (reporting a migraine day on day 1, change from baseline in weekly migraine days [WMDs] at weeks 1-4, and in MMDs in the first 4 weeks) and functional endpoints evaluated by the Activity Impairment in Migraine-Diary (AIM-D) at weeks 1-4 and the European Quality-of-Life 5-Dimension 5-Level (EQ-5D-5L) at weeks 1-2 and 4.

resultsThe modified intent-to-treat population included the ADVANCE (atogepant, n = 222; placebo, n = 214), ELEVATE (atogepant, n = 151; placebo, n = 154), and PROGRESS (atogepant, n = 256; placebo, n = 246) studies. Atogepant-treated participants had greater reductions in the proportion of participants with a migraine day on day 1. The odds ratio compared with placebo was 0.39 (95% CI 0.23-0.67; DISCUSSIONS: Atogepant 60 mg QD demonstrated superiority to placebo in efficacy and functional measures in the first 4 weeks of treatment across 3 preventive studies, 2 in EM and 1 in CM.

trial registrationClinicalTrials.gov NCT03777059; NCT04740827; NCT03855137. Submitted: 12/13/2018; 02/02/2021; 02/25/2019. First patient enrolled: 12/14/2018; 03/05/2021; 03/11/2019 clinicaltrials.gov/ct2/show/NCT03777059. clinicaltrials.gov/ct2/show/NCT04740827 clinicaltrials.gov/ct2/show/NCT03855137. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that atogepant 60 mg QD reduces migraine frequency and improves functional outcomes within 4 weeks of initiation in patients with EM and patients with CM.

Indexed as

Calcitonin Gene-Related Peptide Receptor AntagonistsMigraine DisordersAdolescentAdultAgedAged, 80 and overDouble-Blind MethodFemaleHumansMaleMiddle AgedQuality of LifeTreatment OutcomeYoung AdultCalcitonin Gene-Related Peptide Receptor Antagonists

Identifiers

PMID39715475
PMCPMC11668519

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.