Evidence map›Paper›PMID 32075406›Full record

Trial reportCephalalgia : an international journal of headache2020

Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1).

Messoud Ashina, Joel Saper, Roger Cady, Barbara A Schaeffler, David M Biondi, Joe Hirman, Susan Pederson, Brent Allan, Jeff Smith

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIControlled Clinical TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cephalalgia : an international journal of headache, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05570149 (EptinezuMaB in ReAl-world evidenCE), which is not on this map. Cited by 178 papers, 21 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
178citing papers in PubMed, 21 pooled it
38.0field-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.

NCT05570149 recruitingnot on this mapstarted 2023, after this paper: background citation

EptinezuMaB in ReAl-world evidenCE: a 12-Months, Multicenter, Real-Life, Cohort Study in High-Frequency Episodic and Chronic Migraine (the EMBRACE Study)

Typeobservational_patient_registrySponsorIRCCS San Raffaele RomaRan2023 to 2026Enrolled500ConditionsMigraine DisordersArmsEptinezumab 100 mg or Eptinezumab 300 mg administered intravenously in 100 mL saline solution
3 · Its place in the literature

Who cites it

178 citing papers in PubMed, 21 syntheses or guidelines pooled it, 388 citations in OpenAlex.

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  11. Headaches in adults in supplementary health: management.Revista da Associacao Medica Brasileira (1992) · 2024
    Guideline
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118 more citing papers are in PubMed but not listed here.

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

9 authors at 5 institutions in 2 countries.

Messoud AshinaDanish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Joel SaperMichigan Headache & Neurological Institute, Ann Arbor, MI, USA.
Roger CadyLundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA.
Barbara A SchaefflerLundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA.
David M BiondiAlder BioPharmaceuticals, Inc., Bothell, WA, USA.
Joe HirmanPacific Northwest Statistical Consulting, Inc., Woodinville, WA, USA.
Susan PedersonLundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA.
Brent AllanAlder BioPharmaceuticals, Inc., Bothell, WA, USA.
Jeff SmithLundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA.
Lundbeck (United States) · USAlder (United States) · USMichigan Headache and Neurological Institute · USSeagen (United States) · USUniversity of Copenhagen · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the efficacy and safety of eptinezumab, a humanized anti-calcitonin gene-related peptide monoclonal antibody, in the preventive treatment of episodic migraine.

methodsThe PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy-1 (PROMISE-1) study was a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Adults with episodic migraine were randomized to eptinezumab 30 mg, 100 mg, 300 mg, or placebo for up to four intravenous (IV) doses administered every 12 weeks. The primary endpoint was change from baseline in monthly migraine days (MMDs) over weeks 1-12.

resultsA total of 888 patients received treatment across 84 study sites. Mean MMDs at baseline was ∼8.6 across treatment groups. Eptinezumab 100 mg and 300 mg met the primary endpoint, significantly reducing MMDs across weeks 1-12 compared with placebo (30 mg, -4.0; 100 mg, -3.9,

conclusionEptinezumab (100 mg or 300 mg) significantly reduced migraine frequency, was well tolerated, and had an acceptable safety profile when used for the preventive treatment of migraine in adults with episodic migraine.

Indexed as

Administration, IntravenousAdultAntibodies, Monoclonal, HumanizedDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleHumansMaleMiddle AgedMigraine DisordersAntibodies, Monoclonal, HumanizedeptinezumabALD403efficacyepisodic migraineEptinezumabsafety

Identifiers

PMID32075406
PMCPMC7066477
OpenAlexW3007053288

What OpenQuestion holds

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LicenceCC BY-NC
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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.