Evidence map›Paper›PMID 39231342›Full record

Trial reportThe New England journal of medicine2024

A Monoclonal Antibody to PACAP for Migraine Prevention.

Messoud Ashina, Ravinder Phul, Melanie Khodaie, Elin Löf, Ioana Florea

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05133323 (Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Lu AG09222 for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments), which is not on this map. Cited by 47 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 2 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.

NCT05133323 phase2completednot on this map

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Lu AG09222 for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments

TypeinterventionalSponsorH. Lundbeck A/SRan2021 to 2023Enrolled237ConditionsMigraineArmsLu AG09222, Placebo
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Review
  7. Review
  8. Article
  9. Article
  10. Review
  11. Review
  12. Review
  13. Review
  14. Is it time to think about chronotherapy in migraine.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026
    Review
  15. The evolving landscape of primary headache therapy.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026
    Article
  16. Non-neuronal targets for migraine therapy.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026
    Review
  17. Review
  18. Review
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors.

Messoud AshinaFrom the Department of Neurology, Danish Headache Center, Copenhagen University Hospital-Rigshospitalet (M.A.), the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen (M.A.), and H. Lundbeck (R.P., M.K., E.L., I.F.) - all in Copenhagen.
Ravinder PhulFrom the Department of Neurology, Danish Headache Center, Copenhagen University Hospital-Rigshospitalet (M.A.), the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen (M.A.), and H. Lundbeck (R.P., M.K., E.L., I.F.) - all in Copenhagen.
Melanie KhodaieFrom the Department of Neurology, Danish Headache Center, Copenhagen University Hospital-Rigshospitalet (M.A.), the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen (M.A.), and H. Lundbeck (R.P., M.K., E.L., I.F.) - all in Copenhagen.
Elin LöfFrom the Department of Neurology, Danish Headache Center, Copenhagen University Hospital-Rigshospitalet (M.A.), the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen (M.A.), and H. Lundbeck (R.P., M.K., E.L., I.F.) - all in Copenhagen.
Ioana FloreaFrom the Department of Neurology, Danish Headache Center, Copenhagen University Hospital-Rigshospitalet (M.A.), the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen (M.A.), and H. Lundbeck (R.P., M.K., E.L., I.F.) - all in Copenhagen.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTargeting pituitary adenylate cyclase-activating polypeptide (PACAP) is a new avenue for treating migraine. The efficacy and safety of intravenous Lu AG09222, a humanized monoclonal antibody directed against the PACAP ligand, for migraine prevention are unclear.

methodsIn a phase 2, double-blind, randomized, placebo-controlled trial, we enrolled adult participants (18 to 65 years of age) with migraine for whom two to four previous preventive treatments had failed to provide a benefit. The trial included a 4-week treatment period and an 8-week follow-up period. Participants were randomly assigned in a 2:1:2 ratio to receive a single-dose baseline infusion of 750 mg of Lu AG09222, 100 mg of Lu AG09222, or placebo. The primary end point was the mean change from baseline in the number of migraine days per month, during weeks 1 through 4, in the Lu AG09222 750-mg group as compared with the placebo group.

resultsOf 237 participants enrolled, 97 received 750 mg of Lu AG09222, 46 received 100 mg of Lu AG09222, and 94 received placebo. The mean number of baseline migraine days per month was 16.7 in the overall population, and the mean change from baseline over weeks 1 through 4 was -6.2 days in the Lu AG09222 750-mg group, as compared with -4.2 days in the placebo group (difference, -2.0 days; 95% confidence interval, -3.8 to -0.3; P = 0.02). Adverse events with a higher incidence in the Lu AG09222 750-mg group than in the placebo group during the 12-week observation period included coronavirus disease 2019 (7% vs. 3%), nasopharyngitis (7% vs. 4%), and fatigue (5% vs. 1%).

conclusionsIn a phase 2 trial, a single intravenous infusion of 750 mg of Lu AG09222 showed superiority over placebo in reducing migraine frequency over the subsequent 4 weeks. (Funded by H. Lundbeck; HOPE ClinicalTrials.gov number, NCT05133323.).

Indexed as

Antibodies, Monoclonal, HumanizedMigraine DisordersPituitary Adenylate Cyclase-Activating PolypeptideAdolescentAdultAgedDouble-Blind MethodFemaleHumansInfusions, IntravenousMaleMiddle AgedSymptom Flare UpYoung AdultAntibodies, Monoclonal, HumanizedPituitary Adenylate Cyclase-Activating Polypeptide

Identifiers

PMID39231342

What OpenQuestion holds

Textmetadata
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.