Evidence map›Paper›PMID 35302389›Full record

Trial reportCephalalgia : an international journal of headache2022

Efficacy and safety of eptinezumab in patients with migraine and self-reported aura: Post hoc analysis of PROMISE-1 and PROMISE-2.

Messoud Ashina, Peter McAllister, Roger Cady, Joe Hirman, Anders Ettrup

2 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Cephalalgia : an international journal of headache, 2022. 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 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 9% 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.

NCT02559895 phase3completednot on this map

A Parallel Group, Double-Blind, Randomized, Placebo Controlled, Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients With Frequent Episodic Migraines

TypeinterventionalSponsorAlder Biopharmaceuticals, Inc.Ran2015 to 2017Enrolled898ConditionsMigraine DisordersArmsALD403, Placebo
NCT02974153 phase3completednot on this map

A Parallel Group, Double-Blind, Randomized, Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients With Chronic Migraine

TypeinterventionalSponsorAlder Biopharmaceuticals, Inc.Ran2016 to 2018Enrolled1,121ConditionsMigraine DisordersArmsALD403 (Eptinezumab), Placebo
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.

  1. Pooled it
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  5. Observational
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  12. Calcitonin gene-related peptide causes migraine aura.The journal of headache and pain · 2023
    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

5 authors at 4 institutions in 2 countries.

Messoud AshinaDanish Headache Center, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark.
Peter McAllisterNew England Institute for Neurology and Headache, Stamford, CT, USA.
Roger CadyLundbeck LLC, Deerfield, IL, USA.
Joe HirmanPacific Northwest Statistical Consulting, Inc., Woodinville, WA, USA.
Anders EttrupH. Lundbeck A/S, Copenhagen, Denmark.
Deerfield (United States) · USLundbeck (Denmark) · DKNew England Institute for Neurology and Headache · USRigshospitalet · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis post hoc subgroup analysis evaluated the efficacy and safety of eptinezumab for migraine prevention in patients with migraine and self-reported aura.

methodsPROMISE-1 (NCT02559895; episodic migraine) and PROMISE-2 (NCT02974153; chronic migraine) were randomized, double-blind, placebo-controlled trials that evaluated eptinezumab for migraine prevention. In both studies, the primary outcome was the mean change from baseline in monthly migraine days over Weeks 1-12. Patients in this analysis included those who self-reported migraine with aura at screening.

resultsOf patients with episodic migraine, ∼75% reported a history of aura at screening; of patients with chronic migraine, ∼35% reported a history of aura. Changes in monthly migraine days over Weeks 1-12 were -4.0 (100 mg) and -4.2 (300 mg) with eptinezumab versus -3.1 with placebo in patients with episodic migraine with aura, and were -7.1 (100 mg) and -7.6 (300 mg) with eptinezumab versus -6.0 with placebo in patients with chronic migraine with aura. Treatment-emergent adverse events were reported by 56.0% (100 mg), 57.4% (300 mg), and 55.4% (placebo) of patients.

conclusionsThe preventive migraine efficacy of eptinezumab in patients in the PROMISE studies who self-reported aura was comparable to the overall study populations, demonstrating a similarly favorable safety and tolerability profile.Trial registration: ClinicalTrials.gov Identifiers: NCT02559895 and NCT02974153.

Indexed as

EpilepsyMigraine DisordersMigraine with AuraAntibodies, Monoclonal, HumanizedDouble-Blind MethodHumansSelf ReportTreatment OutcomeAntibodies, Monoclonal, HumanizedeptinezumabefficacyEptinezumabmigraine preventionmigraine with aura

Identifiers

PMID35302389
PMCPMC9218409
OpenAlexW4221090951

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.