Evidence map›Paper›PMID 38195378›Full record

Trial reportThe journal of headache and pain2024

Double-blind, randomized, placebo-controlled study to evaluate erenumab-specific central effects: an fMRI study.

Hauke Basedau, Kuan-Po Peng, Marlene Schellong, Arne May

Open access · goldAbstract 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. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 8% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

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

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

4 authors at 1 institution in 1 country.

Hauke BasedauDepartment of Systems Neuroscience, University Medical Center Hamburg-Eppendorf Martinistr. 52, 20246, Hamburg, Germany.
Kuan-Po PengDepartment of Systems Neuroscience, University Medical Center Hamburg-Eppendorf Martinistr. 52, 20246, Hamburg, Germany.
Marlene SchellongDepartment of Systems Neuroscience, University Medical Center Hamburg-Eppendorf Martinistr. 52, 20246, Hamburg, Germany.
Arne MayDepartment of Systems Neuroscience, University Medical Center Hamburg-Eppendorf Martinistr. 52, 20246, Hamburg, Germany. a.may@uke.de.
Universität Hamburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveGiven the findings of central effects of erenumab in the literature, we aimed to conduct a rigorous placebo-controlled, double-blind, randomized study to elucidate whether the observed changes are directly attributable to the drug.

methodsWe recruited 44 patients with migraine, randomly assigning them to either the erenumab 70 mg or the placebo group. 40 patients underwent fMRI scanning using a trigeminal nociceptive paradigm both, pre- and four weeks post-treatment. Participants kept a headache diary throughout the whole study period of two months in total. A clinical response was defined as a ≥30% reduction in headache frequency at follow-up. Details of this study have been preregistered in the open science framework: https://osf.io/ygf3t .

resultsSeven participants of the verum group (n=33.33%) and 4 of the placebo group (21.05%) experienced improvements in migraine activity, characterized by a minimum of 30% reduction in monthly headache frequency compared to baseline. The imaging data show an interaction between the verum medication and the response. Whilst numbers were too small for individual analyses (Verum vs. Placebo and Responder vs. Non-Responder), the variance-weighted analysis (Verum vs Placebo, scan before vs after weighted for response) revealed specific decrease in thalamic, opercular and putamen activity.

interpretationThe central effects of erenumab could be reproduced in a placebo randomized design, further confirming its central role in migraine modulation. The mechanism, whether direct or secondary to peripheral mode of action, needs further exploration. It is important to note that the response rate to erenumab 70mg in this study was not as substantial as anticipated in 2019, when this study was planned. This resulted in a too small sample size for a subgroup analysis based on the responder status was associated with both the verum drug and the relative reduction in headache days.

Indexed as

Magnetic Resonance ImagingMigraine DisordersAntibodies, Monoclonal, HumanizedDouble-Blind MethodHeadacheHumansAntibodies, Monoclonal, HumanizederenumabCGRP antibodiesDouble-blindfMRIHeadacheHypothalamusPlacebo-effect

Identifiers

PMID38195378
PMCPMC10775481
OpenAlexW4390744327

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.