Evidence map›Paper›PMID 32209650›Full record

Trial reportNeurology2020

Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2.

Richard B Lipton, Peter J Goadsby, Jeff Smith, Barbara A Schaeffler, David M Biondi, Joe Hirman, Susan Pederson, Brent Allan, Roger Cady

Erratum issued 4 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 4 registered trials, which are not on this map. Cited by 193 papers, 20 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
193citing papers in PubMed, 20 pooled it
38.8field-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.

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
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
NCT07040813 phase3recruitingnot on this mapstarted 2025, after this paper: background citation

A Randomized Placebo-controlled Double-blind Phase III Trial to Investigate the Reduction of Monthly Migraine Days (MMDs) Over 12 Weeks of Treatment With CGRP mAbs and Onabotulinumtoxin A Intramuscularly Compared With CGRP mAbs and Placebo in Chronic Migraine

TypeinterventionalSponsorOslo University HospitalRan2025 to 2029Enrolled450ConditionsMigraine, Chronic Migraine HeadacheArmsCGRP mAbs and onabotulinumtoxin A, CGRP mAbs and placebo
NCT07103694 recruitingnot on this mapstarted 2022, after this paper: background citation

Italian Real-life Multicenter Observational Study on Efficacy, Tolerability, and Safety of Innovative Drugs (Monoclonal Antibodies, Gepants, Ditans, Sumatriptan-naproxen) for Preventive or Acute Migraine Treatment.

Typeobservational_patient_registrySponsorIRCCS San Raffaele RomaRan2022 to 2026Enrolled2,641ConditionsEpisodic Migraine, Chronic Migraine, Medication Overuse HeadacheArmsanti-CGRP monoclonal antibodies, gepants, combination of sumatriptan and naproxen, ditan
3 · Its place in the literature

Who cites it

193 citing papers in PubMed, 20 syntheses or guidelines pooled it, 380 citations in OpenAlex.

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133 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 2 countries.

Richard B LiptonFrom the Montefiore Headache Center (R.B.L.); Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Alder BioPharmaceuticals, Ltd (J.S.), Dublin, Ireland; Lundbeck Seattle BioPharmaceuticals, Inc (B.A.S., D.M.B., S.P., B.A., R.C.), Bothell, WA; and Pacific Northwest Statistical Consulting, Inc (J.H.), Woodinville, WA. Dr. Biondi is now at Cohen Veterans Bioscience, Cambridge, MA. Dr. Allan is now at Global Safety Docs, Paradise Valley, AZ. richard.lipton@einsteinmed.org.
Peter J GoadsbyFrom the Montefiore Headache Center (R.B.L.); Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Alder BioPharmaceuticals, Ltd (J.S.), Dublin, Ireland; Lundbeck Seattle BioPharmaceuticals, Inc (B.A.S., D.M.B., S.P., B.A., R.C.), Bothell, WA; and Pacific Northwest Statistical Consulting, Inc (J.H.), Woodinville, WA. Dr. Biondi is now at Cohen Veterans Bioscience, Cambridge, MA. Dr. Allan is now at Global Safety Docs, Paradise Valley, AZ.
Jeff SmithFrom the Montefiore Headache Center (R.B.L.); Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Alder BioPharmaceuticals, Ltd (J.S.), Dublin, Ireland; Lundbeck Seattle BioPharmaceuticals, Inc (B.A.S., D.M.B., S.P., B.A., R.C.), Bothell, WA; and Pacific Northwest Statistical Consulting, Inc (J.H.), Woodinville, WA. Dr. Biondi is now at Cohen Veterans Bioscience, Cambridge, MA. Dr. Allan is now at Global Safety Docs, Paradise Valley, AZ.
Barbara A SchaefflerFrom the Montefiore Headache Center (R.B.L.); Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Alder BioPharmaceuticals, Ltd (J.S.), Dublin, Ireland; Lundbeck Seattle BioPharmaceuticals, Inc (B.A.S., D.M.B., S.P., B.A., R.C.), Bothell, WA; and Pacific Northwest Statistical Consulting, Inc (J.H.), Woodinville, WA. Dr. Biondi is now at Cohen Veterans Bioscience, Cambridge, MA. Dr. Allan is now at Global Safety Docs, Paradise Valley, AZ.
David M BiondiFrom the Montefiore Headache Center (R.B.L.); Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Alder BioPharmaceuticals, Ltd (J.S.), Dublin, Ireland; Lundbeck Seattle BioPharmaceuticals, Inc (B.A.S., D.M.B., S.P., B.A., R.C.), Bothell, WA; and Pacific Northwest Statistical Consulting, Inc (J.H.), Woodinville, WA. Dr. Biondi is now at Cohen Veterans Bioscience, Cambridge, MA. Dr. Allan is now at Global Safety Docs, Paradise Valley, AZ.
Joe HirmanFrom the Montefiore Headache Center (R.B.L.); Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Alder BioPharmaceuticals, Ltd (J.S.), Dublin, Ireland; Lundbeck Seattle BioPharmaceuticals, Inc (B.A.S., D.M.B., S.P., B.A., R.C.), Bothell, WA; and Pacific Northwest Statistical Consulting, Inc (J.H.), Woodinville, WA. Dr. Biondi is now at Cohen Veterans Bioscience, Cambridge, MA. Dr. Allan is now at Global Safety Docs, Paradise Valley, AZ.
Susan PedersonFrom the Montefiore Headache Center (R.B.L.); Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Alder BioPharmaceuticals, Ltd (J.S.), Dublin, Ireland; Lundbeck Seattle BioPharmaceuticals, Inc (B.A.S., D.M.B., S.P., B.A., R.C.), Bothell, WA; and Pacific Northwest Statistical Consulting, Inc (J.H.), Woodinville, WA. Dr. Biondi is now at Cohen Veterans Bioscience, Cambridge, MA. Dr. Allan is now at Global Safety Docs, Paradise Valley, AZ.
Brent AllanFrom the Montefiore Headache Center (R.B.L.); Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Alder BioPharmaceuticals, Ltd (J.S.), Dublin, Ireland; Lundbeck Seattle BioPharmaceuticals, Inc (B.A.S., D.M.B., S.P., B.A., R.C.), Bothell, WA; and Pacific Northwest Statistical Consulting, Inc (J.H.), Woodinville, WA. Dr. Biondi is now at Cohen Veterans Bioscience, Cambridge, MA. Dr. Allan is now at Global Safety Docs, Paradise Valley, AZ.
Roger CadyFrom the Montefiore Headache Center (R.B.L.); Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Alder BioPharmaceuticals, Ltd (J.S.), Dublin, Ireland; Lundbeck Seattle BioPharmaceuticals, Inc (B.A.S., D.M.B., S.P., B.A., R.C.), Bothell, WA; and Pacific Northwest Statistical Consulting, Inc (J.H.), Woodinville, WA. Dr. Biondi is now at Cohen Veterans Bioscience, Cambridge, MA. Dr. Allan is now at Global Safety Docs, Paradise Valley, AZ.
Seagen (United States) · USDepartment of Veterans Affairs · AUKing's College - North Carolina · USAlbert Einstein College of Medicine · US

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 chronic migraine (CM).

methodsThe Prevention of Migraine via Intravenous ALD403 Safety and Efficacy-2 (PROMISE-2) study was a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Adults with CM were randomly assigned to receive IV eptinezumab 100 mg, eptinezumab 300 mg, or placebo administered on day 0 and week 12. The primary endpoint was change from baseline in mean monthly migraine days (MMDs) over weeks 1 to 12.

resultsAmong treated participants (n = 1,072), baseline mean number of MMDs was ≈16.1 across groups. Treatment with eptinezumab 100 and 300 mg was associated with significant reductions in MMDs across weeks 1 to 12 compared with placebo (placebo -5.6, 100 mg -7.7,

conclusionIn patients with CM, eptinezumab 100 and 300 mg was associated with a significant reduction in MMDs from the day after IV administration through week 12, was well tolerated, and demonstrated an acceptable safety profile. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for patients with CM, a single dose of eptinezumab reduces MMDs over 12 weeks of treatment. CLINICALTRIALSGOV IDENTIFIER: NCT02974153.

Indexed as

AdultAntibodies, Monoclonal, HumanizedChronic DiseaseDouble-Blind MethodFemaleHumansMaleMiddle AgedMigraine DisordersTreatment OutcomeAntibodies, Monoclonal, Humanizedeptinezumab

Identifiers

PMID32209650
PMCPMC7274916
OpenAlexW3013502865

What OpenQuestion holds

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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 OpenQuestion graph.