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The Journal of Headache and Pain

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Open Access 01-12-2024 | Erenumab | Research

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

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

Published in: The Journal of Headache and Pain | Issue 1/2024

Abstract

Objective

Given 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.

Methods

We 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.

Results

Seven 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.

Interpretation

The 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.

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Title: Double-blind, randomized, placebo-controlled study to evaluate erenumab-specific central effects: an fMRI study
Authors: Hauke Basedau
Kuan-Po Peng
Marlene Schellong
Arne May
Publication date: 01-12-2024
Publisher: Springer Milan
Keywords: Erenumab
Migraine
Headache
Published in: The Journal of Headache and Pain / Issue 1/2024
Print ISSN: 1129-2369
Electronic ISSN: 1129-2377
DOI: https://doi.org/10.1186/s10194-023-01709-8

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Objective

Methods

Results

Interpretation

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Objective

Methods

Results

Interpretation

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