Evidence map›Paper›PMID 36396451›Full record

Trial reportNeurology2023

Effect of Atogepant for Preventive Migraine Treatment on Patient-Reported Outcomes in the Randomized, Double-blind, Phase 3 ADVANCE Trial.

Richard B Lipton, Patricia Pozo-Rosich, Andrew M Blumenfeld, Ye Li, Lawrence Severt, Jonathan T Stokes, Lela Creutz, Pranav Gandhi, David Dodick

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
4.2field-weighted citation impact, top 5% of its field
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
NCT06882122 recruitingnot on this mapstarted 2024, after this paper: background citation

Neurophysiological and Biomolecular Effects of Atogepant in High Frequency Episodic Migraine (ATOM Project)

TypeobservationalSponsorIRCCS National Neurological Institute "C. Mondino" FoundationRan2024 to 2026Enrolled30ConditionsMigraine Disorder, Episodic MigraineArmsAtogepant 60 mg
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 29 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Richard B LiptonFrom the Albert Einstein College of Medicine and the Montefiore Headache Center (R.B.L.), Bronx, NY; Headache Unit, Neurology Department (P.P.-R.), Vall d'Hebron University Hospital, Barcelona; Headache Research Group, VHIR (P.P.-R.), Universitat Autonoma of Barcelona, Barcelona, Spain; Headache Center of Southern California (A.M.B.), Carlsbad, CA; AbbVie (Y.L., L.S., J.T.S., P.G.), Madison, NJ; Peloton Advantage LLC, an OPEN Health Company (L.C.), Parsippany, NJ; and Department of Neurology (D.W.D.), Mayo Clinic, Scottsdale, AZ. richard.lipton@einsteinmed.edu.
Patricia Pozo-RosichFrom the Albert Einstein College of Medicine and the Montefiore Headache Center (R.B.L.), Bronx, NY; Headache Unit, Neurology Department (P.P.-R.), Vall d'Hebron University Hospital, Barcelona; Headache Research Group, VHIR (P.P.-R.), Universitat Autonoma of Barcelona, Barcelona, Spain; Headache Center of Southern California (A.M.B.), Carlsbad, CA; AbbVie (Y.L., L.S., J.T.S., P.G.), Madison, NJ; Peloton Advantage LLC, an OPEN Health Company (L.C.), Parsippany, NJ; and Department of Neurology (D.W.D.), Mayo Clinic, Scottsdale, AZ.
Andrew M BlumenfeldFrom the Albert Einstein College of Medicine and the Montefiore Headache Center (R.B.L.), Bronx, NY; Headache Unit, Neurology Department (P.P.-R.), Vall d'Hebron University Hospital, Barcelona; Headache Research Group, VHIR (P.P.-R.), Universitat Autonoma of Barcelona, Barcelona, Spain; Headache Center of Southern California (A.M.B.), Carlsbad, CA; AbbVie (Y.L., L.S., J.T.S., P.G.), Madison, NJ; Peloton Advantage LLC, an OPEN Health Company (L.C.), Parsippany, NJ; and Department of Neurology (D.W.D.), Mayo Clinic, Scottsdale, AZ.
Ye LiFrom the Albert Einstein College of Medicine and the Montefiore Headache Center (R.B.L.), Bronx, NY; Headache Unit, Neurology Department (P.P.-R.), Vall d'Hebron University Hospital, Barcelona; Headache Research Group, VHIR (P.P.-R.), Universitat Autonoma of Barcelona, Barcelona, Spain; Headache Center of Southern California (A.M.B.), Carlsbad, CA; AbbVie (Y.L., L.S., J.T.S., P.G.), Madison, NJ; Peloton Advantage LLC, an OPEN Health Company (L.C.), Parsippany, NJ; and Department of Neurology (D.W.D.), Mayo Clinic, Scottsdale, AZ. richard.lipton@einsteinmed.edu.
Lawrence SevertFrom the Albert Einstein College of Medicine and the Montefiore Headache Center (R.B.L.), Bronx, NY; Headache Unit, Neurology Department (P.P.-R.), Vall d'Hebron University Hospital, Barcelona; Headache Research Group, VHIR (P.P.-R.), Universitat Autonoma of Barcelona, Barcelona, Spain; Headache Center of Southern California (A.M.B.), Carlsbad, CA; AbbVie (Y.L., L.S., J.T.S., P.G.), Madison, NJ; Peloton Advantage LLC, an OPEN Health Company (L.C.), Parsippany, NJ; and Department of Neurology (D.W.D.), Mayo Clinic, Scottsdale, AZ.
Jonathan T StokesFrom the Albert Einstein College of Medicine and the Montefiore Headache Center (R.B.L.), Bronx, NY; Headache Unit, Neurology Department (P.P.-R.), Vall d'Hebron University Hospital, Barcelona; Headache Research Group, VHIR (P.P.-R.), Universitat Autonoma of Barcelona, Barcelona, Spain; Headache Center of Southern California (A.M.B.), Carlsbad, CA; AbbVie (Y.L., L.S., J.T.S., P.G.), Madison, NJ; Peloton Advantage LLC, an OPEN Health Company (L.C.), Parsippany, NJ; and Department of Neurology (D.W.D.), Mayo Clinic, Scottsdale, AZ.
Lela CreutzFrom the Albert Einstein College of Medicine and the Montefiore Headache Center (R.B.L.), Bronx, NY; Headache Unit, Neurology Department (P.P.-R.), Vall d'Hebron University Hospital, Barcelona; Headache Research Group, VHIR (P.P.-R.), Universitat Autonoma of Barcelona, Barcelona, Spain; Headache Center of Southern California (A.M.B.), Carlsbad, CA; AbbVie (Y.L., L.S., J.T.S., P.G.), Madison, NJ; Peloton Advantage LLC, an OPEN Health Company (L.C.), Parsippany, NJ; and Department of Neurology (D.W.D.), Mayo Clinic, Scottsdale, AZ.
Pranav GandhiFrom the Albert Einstein College of Medicine and the Montefiore Headache Center (R.B.L.), Bronx, NY; Headache Unit, Neurology Department (P.P.-R.), Vall d'Hebron University Hospital, Barcelona; Headache Research Group, VHIR (P.P.-R.), Universitat Autonoma of Barcelona, Barcelona, Spain; Headache Center of Southern California (A.M.B.), Carlsbad, CA; AbbVie (Y.L., L.S., J.T.S., P.G.), Madison, NJ; Peloton Advantage LLC, an OPEN Health Company (L.C.), Parsippany, NJ; and Department of Neurology (D.W.D.), Mayo Clinic, Scottsdale, AZ.
David DodickFrom the Albert Einstein College of Medicine and the Montefiore Headache Center (R.B.L.), Bronx, NY; Headache Unit, Neurology Department (P.P.-R.), Vall d'Hebron University Hospital, Barcelona; Headache Research Group, VHIR (P.P.-R.), Universitat Autonoma of Barcelona, Barcelona, Spain; Headache Center of Southern California (A.M.B.), Carlsbad, CA; AbbVie (Y.L., L.S., J.T.S., P.G.), Madison, NJ; Peloton Advantage LLC, an OPEN Health Company (L.C.), Parsippany, NJ; and Department of Neurology (D.W.D.), Mayo Clinic, Scottsdale, AZ.
Universitat Autònoma de Barcelona · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesThe oral calcitonin gene-related peptide receptor antagonist atogepant is indicated for the preventive treatment of episodic migraine. We evaluated changes in patient-reported outcomes with atogepant in adults with migraine.

methodsIn this phase 3, 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial (ADVANCE), adults with 4-14 migraine days per month received atogepant (10, 30, or 60 mg) once daily or placebo. Secondary endpoints included changes from baseline in Migraine-Specific Quality-of-Life Questionnaire (MSQ) version 2.1 Role Function-Restrictive (RFR) domain at week 12 and mean monthly Activity Impairment in Migraine-Diary (AIM-D) Performance of Daily Activities (PDA) and Physical Impairment (PI) domains across the 12-week treatment period. Exploratory endpoints included change in MSQ Role Function-Preventive (RFP) and Emotional Function (EF) domains; AIM-D total scores; and change in Headache Impact Test (HIT)-6 scores.

resultsOf 910 participants randomized, 873 comprised the modified intent-to-treat population (atogepant: 10 mg [n = 214]; 30 mg [n = 223]; and 60 mg [n = 222]; placebo [n = 214]). All atogepant groups demonstrated significantly greater improvements vs placebo in MSQ RFR that exceeded minimum clinically meaningful between-group difference (3.2 points) at week 12 (least-square mean difference [LSMD] vs placebo: 10 mg [9.9]; 30 mg [10.1]; 60 mg [10.8]; all DISCUSSION: Atogepant 30 and 60 mg produced significant improvements in key patient-reported outcomes including MSQ-RFR scores and both AIM-D domains. Nominal improvements also occurred for other MSQ domains and HIT-6, reinforcing the beneficial effects of atogepant as a new treatment for migraine prevention. TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov NCT03777059. Submitted: December 13, 2018; First patient enrolled: December 14, 2018. CLINICALTRIALS: gov/ct2/show/NCT03777059. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that daily atogepant is associated with improvements in health-related quality-of-life measures in patients with 4-14 migraine days per month.

Indexed as

Migraine DisordersAdultDouble-Blind MethodHumansPatient Reported Outcome MeasuresPiperidinesPyridinesPyrrolesQuality of LifeSpiro CompoundsTreatment OutcomeatogepantPiperidinesPyridinesPyrrolesSpiro Compounds

Identifiers

PMID36396451
PMCPMC9984220
OpenAlexW4309263777

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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 Socratic graph.