Evidence map›Paper›PMID 38773375›Full record

Trial reportThe journal of headache and pain2024

Sustained response to atogepant in episodic migraine: post hoc analyses of a 12-week randomized trial and a 52-week long-term safety trial.

Richard B Lipton, Stephanie J Nahas, Patricia Pozo-Rosich, Tanya Bilchik, Peter McAllister, Michelle Finnegan, Yingyi Liu, Natty Chalermpalanupap, Brett Dabruzzo, David W Dodick

2 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The journal of headache and pain, 2024. 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 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–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.

NCT03700320 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Open-label Study to Evaluate the Long-term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine

TypeinterventionalSponsorAllerganRan2018 to 2020Enrolled744ConditionsEpisodic MigraineArmsStandard of Care (SOC) Migraine Preventive Medication, Atogepant
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
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
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  4. Review
  5. Article
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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

10 authors.

Richard B LiptonAlbert Einstein College of Medicine, Bronx, NY, USA.
Stephanie J NahasThomas Jefferson University, Philadelphia, PA, USA.
Patricia Pozo-RosichHeadache Unit, Department of Neurology, Vall d'Hebron University Hospital, Barcelona, Spain.
Tanya BilchikDepartment of Neurology, Yale University School of Medicine, New Haven, CT, USA.
Peter McAllisterNew England Institute for Neurology & Headache, Stamford, CT, USA.
Michelle FinneganAbbVie, North Chicago, IL, USA.
Yingyi LiuAbbVie, North Chicago, IL, USA.
Natty ChalermpalanupapAbbVie, North Chicago, IL, USA.
Brett DabruzzoAbbVie, North Chicago, IL, USA. brett.dabruzzo@abbvie.com.
David W DodickMayo Clinic, Phoenix, AZ, USA.

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
NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

backgroundAtogepant is an oral calcitonin gene-related peptide receptor antagonist approved for the preventive treatment of migraine in adults. These analyses evaluated the proportions of clinical trial participants who experienced sustained responses to atogepant over 12 or 52 weeks of treatment.

methodsThese were post hoc analyses of ADVANCE, a 12-week, double-blind, randomized trial of atogepant 10, 30, and 60 mg once daily vs. placebo for the preventive treatment of episodic migraine, and a separate open-label long-term safety (LTS) trial of atogepant 60 mg once daily over 52 weeks. The 60 mg dose of atogepant was used to detect safety issues. An initial response was defined as ≥50%, ≥75%, or 100% reduction from baseline in MMDs in month 1 for ADVANCE or quarter 1 for the LTS trial. The proportions of participants who continued to experience a response above each response-defining threshold through each subsequent month (for ADVANCE) or each quarter (for LTS) were calculated.

resultsIn ADVANCE, sustained response rates during months 2 and 3 varied with dose and were as follows: 70.8-81.1% following an initial ≥50% response, 47.3-61.9% following an initial ≥75% response, and 34.8-41.7% following an initial 100% response. Of those who experienced an initial ≥75% or 100% response during month 1, more than 79% continued to experience at least a 50% response during both months 2 and 3. During the LTS trial, sustained response rates through quarters 2, 3, and 4 were 84.7% following an initial ≥50% response, 72.6% following an initial ≥75% response, and 37.8% following an initial 100% response. Of those who experienced an initial ≥75% or 100% response during quarter 1, more than 90% continued to experience at least a 50% response through quarters 2, 3, and 4.

conclusionOver 70% of participants who experienced an initial response with atogepant treatment had a sustained response with continued treatment.

trial registrationClinicalTrials.gov: NCT03777059 (submitted: December 13, 2018); NCT03700320 (submitted: September 25, 2018).

Indexed as

Calcitonin Gene-Related Peptide Receptor AntagonistsMigraine DisordersAdultAzepinesDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansMaleMiddle AgedPiperidinesPyridinesPyrrolesSpiro CompoundsTreatment OutcomeatogepantAzepinesCalcitonin Gene-Related Peptide Receptor AntagonistsPiperidinesPyridinesPyrrolesSpiro CompoundsCGRPMigraineResponders

Identifiers

PMID38773375
PMCPMC11107063

What OpenQuestion holds

Textmetadata
LicenceCC BY
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 OpenQuestion graph.