Evidence map›Paper›PMID 36651532›Full record

Trial reportHeadache2023

Once-daily oral atogepant for the long-term preventive treatment of migraine: Findings from a multicenter, randomized, open-label, phase 3 trial.

Messoud Ashina, Stewart J Tepper, Uwe Reuter, Andrew M Blumenfeld, Susan Hutchinson, Jing Xia, Rosa Miceli, Lawrence Severt, Michelle Finnegan, Joel M Trugman

Erratum issuedOpen access · hybridAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Headache, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 28 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 3 pooled it
14.0field-weighted citation impact, top 1% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 3 syntheses or guidelines pooled it, 63 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 3 countries.

Messoud AshinaDanish Headache Center, Department of Neurology, Rigshospitalet Glostrup Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0003-0951-5804
Stewart J TepperDepartment of Neurology, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire, USA.
Uwe ReuterDepartment of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany.
Andrew M BlumenfeldHeadache Center of Southern California, Carlsbad, California, USA.
Susan HutchinsonOrange County Migraine and Headache Center, Irvine, California, USA.ORCID 0000-0001-6353-2846
Jing XiaAbbVie, Madison, New Jersey, USA.
Rosa MiceliAbbVie, Madison, New Jersey, USA.
Lawrence SevertAbbVie, Madison, New Jersey, USA.
Michelle FinneganAbbVie, Madison, New Jersey, USA.
Joel M TrugmanAbbVie, Madison, New Jersey, USA.
New York Times · USAbbVie (United States) · USCharité - Universitätsmedizin Berlin · DEDartmouth College · USNeurology Center of Southern California · USUniversity of Copenhagen · DK

Funding

AbbVie
6 · The paper itself

Abstract

objectiveTo assess long-term safety, tolerability, and efficacy of once-daily oral atogepant 60 mg in adults with migraine.

backgroundAtogepant is an oral, small-molecule, calcitonin gene-related peptide receptor antagonist approved for the preventive treatment of episodic migraine.

methodsA 52-week, multicenter, randomized, open-label trial of adults (18-80 years) with migraine. Lead-in trial completers or newly enrolled participants with 4-14 migraine days/month were enrolled and randomized (5:2) to atogepant 60 mg once daily or oral standard care (SC) migraine preventive medication. The primary objective was to evaluate the safety and tolerability of atogepant; safety assessments included treatment-emergent adverse events (TEAEs), clinical laboratory evaluations, vital signs, and Columbia-Suicide Severity Rating Scale scores. Efficacy assessments (atogepant only) included change from baseline in mean monthly migraine days (MMDs) and the proportion of participants with reductions from baseline of ≥50%, ≥75%, and 100% in MMDs.

resultsThe trial included 744 participants randomized to atogepant 60 mg (n = 546) or SC (n = 198). The atogepant safety population was 88.2% female (n = 479/543) with a mean (standard deviation) age of 42.5 (12.0) years. TEAEs occurred in 67.0% (n = 364/543) of participants treated with atogepant 60 mg. The most commonly reported TEAEs (≥5%) were upper respiratory tract infection (10.3%; 56/543), constipation (7.2%; 39/543), nausea (6.3%; 34/543), and urinary tract infection (5.2%; 28/543). Serious TEAEs were reported in 4.4% (24/543) for atogepant. Mean (standard error) change in MMDs for atogepant was -3.8 (0.1) for weeks 1-4 and -5.2 (0.2) at weeks 49-52. Similarly, the proportion of participants with ≥50%, ≥75%, and 100% reductions in MMDs increased from 60.4% (310/513), 37.2% (191/513), and 20.7% (106/513) at weeks 1-4 to 84.2% (282/335), 69.9% (234/335), and 48.4% (162/335), at weeks 49-52.

conclusionDaily use of oral atogepant 60 mg for preventive treatment of migraine during this 1-year, open-label trial was safe, well tolerated, and efficacious.

Indexed as

Migraine DisordersAdultDouble-Blind MethodFemaleHumansMaleNauseaPiperidinesPyridinesPyrrolesSpiro CompoundsTreatment OutcomeatogepantPiperidinesPyridinesPyrrolesSpiro Compoundsatogepantcalcitonin gene-related peptidegepantmigrainemigraine preventive

Identifiers

PMID36651532
PMCPMC10107835
OpenAlexW4317209460

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.