Evidence map›Paper›PMID 32493206›Full record

Trial reportThe journal of headache and pain2020

Efficacy, tolerability, and safety of erenumab for the preventive treatment of persistent post-traumatic headache attributed to mild traumatic brain injury: an open-label study.

Håkan Ashina, Afrim Iljazi, Haidar Muhsen Al-Khazali, Anna Kristina Eigenbrodt, Eigil Lindekilde Larsen, Amalie Middelboe Andersen, Kevin John Hansen, Karoline Bendix Bräuner, Thomas Mørch-Jessen, Basit Chaudhry and 5 more

3 registry-linked trialsOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in The journal of headache and pain, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 42 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 1 pooled it
6.7field-weighted citation impact, top 2% 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.

NCT03974360 phase2completednot on this map

An Open Label Study to Evaluate the Efficacy and Tolerability of Erenumab in the Prophylactic Treatment of Persistent Headache Attributed to Mild Traumatic Injury to the Head

TypeinterventionalSponsorDanish Headache CenterRan2019 to 2019Enrolled100ConditionsPost-Traumatic Headache, Mild Traumatic Brain Injury, Post-Concussion SyndromeArmsAMG 334
NCT05142228 phase2terminatednot on this mapstarted 2022, after this paper: background citation

Erenumab as a Therapeutic Approach for the Management of Trigeminal Neuropathic Pain (TNP)

TypeinterventionalSponsorUniversity of Maryland, BaltimoreRan2022 to 2022Enrolled5ConditionsTrigeminal NeuropathyArmsErenumab-Aooe, Placebo
NCT05162027 phase2terminatednot on this mapstarted 2022, after this paper: background citation

Erenumab as a Therapeutic Approach for the Management of Painful Chronic Temporomandibular Disorders (TMD)

TypeinterventionalSponsorUniversity of Maryland, BaltimoreRan2022 to 2023Enrolled5ConditionsTemporomandibular DisordersArmsErenumab-Aooe 70 MG in 1 mL Prefilled Syringe, Placebo
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 1 synthesis or guideline pooled it, 74 citations in OpenAlex.

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  17. Pathology of pain and its implications for therapeutic interventions.Signal transduction and targeted therapy · 2024
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 4 institutions in 1 country.

Håkan AshinaDanish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.
Afrim IljaziDanish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.
Haidar Muhsen Al-KhazaliDanish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.
Anna Kristina EigenbrodtDanish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.
Eigil Lindekilde LarsenDanish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.
Amalie Middelboe AndersenDanish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.
Kevin John HansenDanish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.
Karoline Bendix BräunerDanish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.
Thomas Mørch-JessenDanish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.
Basit ChaudhryDanish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.
Sonja AnticDepartment of Neurology, Aarhus University Hospital, Aarhus, Denmark.
Casper Emil ChristensenDanish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.
Messoud AshinaDanish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.
Faisal Mohammad AminDanish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.
Henrik Winther SchytzDanish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark. henrik.winther.schytz.01@regionh.dk.
Rigshospitalet · DKUniversity of Copenhagen · DKGlostrup Hospital · DKAarhus University Hospital · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCalcitonin gene-related peptide (CGRP) has recently been implicated in the pathogenesis of post-traumatic headache (PTH), which raises the prospect for therapeutic use of monoclonal antibodies targeting CGRP or its receptor. Therefore, we decided to assess the efficacy, tolerability, and safety of erenumab for prevention of persistent PTH attributed to mild traumatic brain injury.

methodsA single-center, non-randomized, single-arm, open-label study of erenumab for adults aged 18-65 years with persistent PTH. Patients were assigned to receive 140-mg erenumab monthly by two subcutaneous 1-mL injections, given every 4 weeks for 12 weeks. The primary outcome measure was the mean change in number of monthly headache days of moderate to severe intensity from baseline (4-week pretreatment period) to week 9 through 12. Tolerability and safety endpoints were adverse events (i.e. number and type).

resultsEighty-nine of 100 patients completed the open-label trial. At baseline, the mean monthly number of headache days of moderate to severe intensity was 15.7. By week 9 through 12, the number was reduced by 2.8 days. The most common adverse events were constipation (n = 30) and injection-site reactions (n = 15). Of 100 patients who received at least one dose of erenumab, two patients discontinued the treatment regimen due to adverse events.

conclusionsAmong patients with persistent PTH, erenumab resulted in a lower frequency of moderate to severe headache days in this 12-week open-label trial. In addition, erenumab was well-tolerated as discontinuations due to adverse events were low. Placebo-controlled randomized clinical trials are needed to adequately evaluate the efficacy and safety of erenumab in patients with persistent PTH.

trial registrationClinicalTrials.Gov, NCT03974360. Registered on April 17, 2019 - Retrospectively registered.

Indexed as

AdolescentAdultAgedAntibodies, Monoclonal, HumanizedBrain ConcussionCalcitonin Gene-Related Peptide Receptor AntagonistsDouble-Blind MethodFemaleFollow-Up StudiesHumansInjections, SubcutaneousMaleMiddle AgedPost-Traumatic HeadacheTreatment OutcomeYoung AdultAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related Peptide Receptor AntagonistserenumabClinical managementConcussionHead injuryHead traumaSecondary headache

Identifiers

PMID32493206
PMCPMC7271543
OpenAlexW3028882899

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.