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Chronic migraine; OnabotulinumtoxinA; Predictors of response Migraña crónica; OnabotulinumtoxinA; Predictores de respuesta Migranya crònica; OnabotulinumtoxinA; Predictors de resposta The identification of patients who can benefit the most from the available preventive treatments is important in chronic migraine. We explored the rate of excellent responders to onabotulinumtoxinA in a multicenter European study and explored the predictors of such response, according to different definitions. A pooled analysis on chronic migraineurs treated with onabotulinumtoxinA and followed-up for, at least, 9 months was performed. Excellent responders were defined either as patients with a ≥75% decrease in monthly headache days (percent-based excellent responders) or as patients with

In 1995, a committee of the International Headache Society developed and published the first edition of the Guidelines for Controlled Trials of Drugs in Cluster Headache. These have not been revised. With the emergence of new medications, neuromodulation devices and trial designs, an updated version of the International Headache Society Guidelines for Controlled Clinical Trials in Cluster Headache is warranted. Given the scarcity of evidence-based data for cluster headache therapies, the update is largely consensus-based, but takes into account lessons learned from recent trials and demands by patients. It is intended to apply to both drug and neuromodulation treatments, with specific proposals for the latter when needed. The primary objective is to propose a template for designing high quality, state-of-the-art, controlled clinical trials of acute and preventive treatments in episodic and chronic cluster headache. The recommendations should not be regarded as dogma and alternative solutions to particular methodological problems should be explored in the future and scientifically validated.

Delphi; Migraine; Disability Delphi; Migraña; Discapacidad Delphi; Migranya; Discapacitat Background Migraine-attributed burden, impact, disability and migraine-impacted quality of life are important concepts in clinical management, clinical and epidemiological research, and health policy, requiring clear and agreed definitions. We aimed to formulate concise and precise definitions of these concepts by expert consensus. Methods We searched the terms migraine-attributed burden, impact, disability and migraine-impacted quality of life in Embase and Medline from 1974 and 1946 respectively. We followed a Delphi process to reach consensus on definitions. Results We found widespread conflation of concepts and inconsistent terminology within publications. Following three Delphi rounds, we defined migraine-attributed burden as “the summation of all negative consequences of the disease or its diagnosis”; migraine-attributed impact as “the effect of the disease, or its diagnosis, on a specified aspect of life, health or wellbeing”; migraine-attributed disability as “physical, cognitive and mental incapacities imposed by the disease”; and migraine-impacted quality of life as “the subjective assessment by a person with the disease of their general wellbeing, position and prospects in life”. We complemented each definition with a detailed description. Conclusion These definitions and descriptions should foster consistency and encourage more appropriate use of currently available quantifying instruments and aid the future development of others. The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was funded by Eli Lilly and Company.

Education; Migraine; Training Educación; Migraña; Formación Educació; Migranya; Formació Objective Headache disorders constitute a leading cause of disability worldwide, but there is a consistent absence of awareness and educational activities for healthcare providers across regions. Thus, we found it timely to identify potential structural challenges and factors that may affect acquisition of knowledge of headache disorders and their management during their 4-year residency. Materials & Methods We conducted a nationwide cross-sectional survey of residents in neurology in Denmark including, but not limited to, questions on interest in neurological subspecialties and disorders, adequacy of training in headache disorders, exposure to headache disorders during training including time spent on headache disorders, exposure to specialist outpatient clinics, whether their hospital have a tertiary headache clinic, training in specific procedures (anesthetic blockade, e.g., greater occipital nerve blockade, and onabotulinumtoxinA for headache), and an estimate of proportion of cases with headache among patients managed in the last week. Results The survey was distributed to 127 residents in Denmark between March 2022 and April 2022. Of these, 59 (47%) completed all questions of the survey. Headache disorders were the fourth most popular subspecialties among respondents (n = 15 [25%]) following movement disorders (n = 27 [46%]), vascular neurology (n = 26 [44%]), and neuromuscular disorders (n = 25 [42%]). The mean number of hours spent in a course or a structured educational activity in headache disorders during residency was 12.1 h. Half of respondents (n = 27 [46%]) reported that they perceived their training in headache disorders to be inadequate. Conclusions Even in Denmark, a country with excellent headache services, half of residents in neurology report an inadequate training despite a higher-than-average number of hours of structured educational activities. These findings should incentivize stakeholders to make structural changes to improve education in headache disorders during the most fundamental years of training.

Background and purpose The short-term evolution of pediatric migraine remains unclear. We aimed to describe the evolution of migraine before and after puberty and its relationship with lifestyle habits. Methods We prospectively selected prepuberal patients from a neuropediatric unit who had a migraine diagnosis. Their medical history, migraine characteristics and impact, and lifestyle habits were recorded at the baseline visit. After 2 years we performed a telephone follow-up assessment. Results Nineteen patients were recruited (age 10.2±2.9 years, mean±SD; 57.9% female), of whom 27.5% had migraine with aura. The accompanying symptoms had changed at the follow-up, with significantly higher prevalence rates of dizziness (44.4% vs. 88.9%), vertigo (11.1% vs. 66.7%), mood changes (38.9% vs 83.3%), confusion (5.6% vs. 77.8%), and allodynia (27.8% vs. 61.1%). Sleep disturbances (5.6% vs. 38.9%) and schedule changes (0% vs. 38.9%) increased significantly as triggers. Prodromal symptoms became more prevalent (16.7% vs. 50%), with a higher proportion of sleep disturbances reported (50.0% vs. 87.5%). Conclusions Prodromal symptoms increase in pediatric migraine after 2 years, and some trigger factors for migraine become more prevalent, including sleep disturbances. New accompanying symptoms are also identified. These changes provide information about how migraine changes during puberty along with physical and lifestyle changes, and represent a dynamic physiopathological process that deserves more research.

Objective We explore factors that may have contributed to differences in treatment-emergent adverse events in the phase 2 and phase 3 lasmiditan clinical trials. Background Phase 2 and phase 3 trials showed that the centrally penetrant 5-HT1F agonist, lasmiditan, was effective; higher frequency and severity of adverse events (AEs) were seen in phase 2. Methods This work represents a hybrid of a review of primary documents and study reports with additional post hoc analyses. Protocols, informed consents, data collection forms, and methodologies were reviewed. This information was supplemented by results from the clinical study reports and post hoc analyses of individual patient data from each trial. Results For lasmiditan 100 and 200 mg, in phase 2, the incidence of ≥1 AE was 72-86% (26% severe), while in phase 3 was 36-43% (2% severe). The most common AEs in all studies were CNS-related. The phase 2 consent form was more descriptive of AEs than phase 3. In phase 2, patients recorded AEs and severity in a paper diary that warned about drowsiness and dizziness. In phase 3, patients recorded in electronic diaries whether they experienced unusual feelings after dosing with lasmiditan that they had not felt with a migraine before, and were contacted to determine if an AE had occurred. In phase 2, the AE Schwindel was variably translated from German as "vertigo" or "dizziness," while phase 3 vertigo cases were queried to ensure there was a sensation of rotation or movement. History of recurrent dizziness and/or vertigo was exclusionary in phase 3. Conclusions This work illustrates how informed consent wording, AE collection methods, translation, exclusion criteria, and other factors may be important determinants for reporting of the frequency and severity of AEs in clinical trials.

Supplemental material, sj-pdf-2-cep-10.1177_03331024211068074 for Post-COVID-19 persistent headache: A multicentric 9-months follow-up study of 905 patients by David Garcia-Azorin, Almudena Layos-Romero, Jes��s Porta-Etessam, Javier A Membrilla, Edoardo Caronna, Alicia Gonzalez-Martinez, ��lvaro Sierra Mencia, Tom��s Segura, Nuria Gonzalez-Garc��a, Javier D��az-de-Ter��n, Victor J Gallardo, Ana Beatriz Gago-Veiga, Alejandro Ballv��, Javier Trigo L��pez, Mar��a Sastre-Real, Arnau Llaurad��, Ana Cornejo, ����igo de Lorenzo, ��ngel Guerrero-Peral and Patricia Pozo-Rosich in Cephalalgia

Supplemental material, sj-pdf-1-cep-10.1177_03331024221123081 for Perceived barriers to career progression in the headache field: A global web-based cross-sectional survey by Irene de Boer, Anna Ambrosini, Rashmi B Halker Singh, Betül Baykan, Dawn C Buse, Cristina Tassoreli, Rigmor H Jensen, Patricia Pozo-Rosich and Gisela M Terwindt in Cephalalgia

Supplemental material, sj-pdf-1-cep-10.1177_03331024221111772 for Avoidance behaviour modulates but does not condition phonophobia in migraine by Nara Ikumi, Xim Cerda-Company, Angela Marti-Marca, Adrià Vilà-Balló, Edoardo Caronna, Victor José Gallardo and Patricia Pozo-Rosich in Cephalalgia

Supplemental material, sj-pdf-1-cep-10.1177_03331024211068074 for Post-COVID-19 persistent headache: A multicentric 9-months follow-up study of 905 patients by David Garcia-Azorin, Almudena Layos-Romero, Jes��s Porta-Etessam, Javier A Membrilla, Edoardo Caronna, Alicia Gonzalez-Martinez, ��lvaro Sierra Mencia, Tom��s Segura, Nuria Gonzalez-Garc��a, Javier D��az-de-Ter��n, Victor J Gallardo, Ana Beatriz Gago-Veiga, Alejandro Ballv��, Javier Trigo L��pez, Mar��a Sastre-Real, Arnau Llaurad��, Ana Cornejo, ����igo de Lorenzo, ��ngel Guerrero-Peral and Patricia Pozo-Rosich in Cephalalgia

Additional file 1: Figure S1. PRISMA flowchart of systematic review. Table S1. Pain relief at different timepoints. Table S2. Pain relief and pain-free at 2 hours. Table S3. Headache recurrence within 24 hours. Table S4. Rescue medication. Table S5. Response in triptan non-responders. Table S6. Comparisons of different triptan formulations. Table S7. Comparisons between early and late treatment with triptans. Table S8. Agreement on questions submitted in Round 1. Table S9. Conflicts of interest of the authors.

Supplemental material, sj-pdf-2-cep-10.1177_03331024221110102 for Migraine-attributed burden, impact and disability, and migraine-impacted quality of life: Expert consensus on definitions from a Delphi process by Timothy J Steiner, Gisela M Terwindt, Zaza Katsarava, Patricia Pozo-Rosich, Andreas R Gantenbein, Sarah L Roche, Grazia Dell’Agnello and Cristina Tassorelli in Cephalalgia

Supplemental material, sj-pdf-1-cep-10.1177_03331024221110102 for Migraine-attributed burden, impact and disability, and migraine-impacted quality of life: Expert consensus on definitions from a Delphi process by Timothy J Steiner, Gisela M Terwindt, Zaza Katsarava, Patricia Pozo-Rosich, Andreas R Gantenbein, Sarah L Roche, Grazia Dell’Agnello and Cristina Tassorelli in Cephalalgia

Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Anticuerpos monoclonales; Migraña Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Anticossos monoclonals; Migranya Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Monoclonal antibodies; Migraine Background and objective CGRP, a neuropeptide involved in migraine pathophysiology, is also known to play a role in the respiratory system and in immunological conditions such as sepsis. We analyzed the impact of the use of CGRP antagonists in patients with migraine during the COVID-19 pandemic, caused by the SARS-CoV-2 coronavirus. Methods This is a multicentre cross-sectional study. From May to November 2020, through a national survey distributed by the Spanish Society of Neurology, we collected data about the presence of COVID-19 symptoms including headache and their characteristics and severity in patients with migraine treated with anti-CGRP monoclonal antibodies (mAb), and compared them with patients with migraine not receiving this treatment. We also conducted a subanalysis of patients with COVID-19 symptoms. Results We recruited 300 patients with migraine: 51.7% (155/300) were taking anti-CGRP mAbs; 87.3% were women (262/300). Mean age (standard deviation) was 47.1 years (11.6). Forty-one patients (13.7%) met diagnostic criteria for COVID-19, with no statistically significant difference between patients with and without anti-CGRP mAb treatment (16.1% vs 11.0%, respectively; P = .320). Of the patients with COVID-19, 48.8% (20/41) visited the emergency department and 12.2% (5/41) were hospitalised. Likewise, no clinical differences were found between the groups of patients with and without anti-CGRP mAb treatment. Conclusion Anti-CGRP mAbs may be safe in clinical practice, presenting no association with increased risk of COVID-19. Antecedentes y objetivo El péptido relacionado con el gen de la calcitonina (CGRP, por sus siglas en inglés), es un neuropéptido involucrado en la fisiopatología de la migraña, que también es conocido por participar en la regulación del sistema respiratorio y en algunas enfermedades inmunológicas como la sepsis. Hemos analizado el impacto del uso de los antagonistas de CGRP en pacientes con migraña durante la pandemia de COVID-19, causada por el coronavirus SARS-CoV-2. Métodos Estudio transversal multicéntrico desarrollado entre mayo y noviembre de 2020, en el que la Sociedad Española de Neurología distribuyó a nivel nacional una encuesta de la que recogimos datos sobre la presencia, las características y la gravedad de síntomas de COVID-19, entre los que se encontraba la cefalea, en pacientes con migraña tratados con anticuerpos monoclonales (AcM) anti-CGRP, y los comparamos con los de pacientes con migraña que no recibían dicho tratamiento. También realizamos un subanálisis de los pacientes con síntomas de COVID-19. Resultados Identificamos 300 pacientes con migraña: 51,7% (155/300) recibían AcM anti-CGRP; el 87,3% eran mujeres (262/300) y la edad media (desviación estándar) de la muestra fue de 47,1 (11,6) años. Un total de 41 pacientes (13,7%) cumplían los criterios diagnósticos de COVID-19, sin diferencias estadísticamente significativas entre los pacientes que recibían tratamiento con AcM anti-CGRP y los que no (16,1% y 11,0%, respectivamente; p = 0,320). De los pacientes con COVID-19, el 48,8% (20/41) acudieron a urgencias y el 12,2% (5/41) fueron hospitalizados. Igualmente, no se detectaron diferencias clínicas entre los pacientes que recibían dicho tratamiento y los que no. Conclusión El tratamiento con AcM anti-CGRP parece un recurso seguro en la práctica clínica, y no se asocia a un mayor riesgo de COVID-19. No funding was received for this study.

Non-invasive neuromodulation therapies for migraine and cluster headache are a practical and safe alternative to pharmacologics. Comparisons of these therapies are difficult because of the heterogeneity in study designs. In this systematic review of clinical trials, the scientific rigour and clinical relevance of the available data were assessed to inform clinical decisions about non-invasive neuromodulation. PubMed, Cochrane Library and ClinicalTrials.gov databases and the WHO’s International Clinical Trials Registry Platform were searched for relevant clinical studies of non-invasive neuromodulation devices for migraine and cluster headache (1 January 1990 to 31 January 2018), and 71 were identified. This analysis compared study designs using recommendations of the International Headache Society for pharmacological clinical trials, the only available guidelines for migraine and cluster headache. Non-invasive vagus nerve stimulation (nVNS), single-transcranial magnetic stimulation and external trigeminal nerve stimulation (all with regulatory clearance) were well studied compared with the other devices, for which studies frequently lacked proper blinding, sham controls and sufficient population sizes. nVNS studies demonstrated the most consistent adherence to available guidelines. Studies of all neuromodulation devices should strive to achieve the same high level of scientific rigour to allow for proper comparison across devices. Device-specific guidelines for migraine and cluster headache will be soon available, but adherence to current guidelines for pharmacological trials will remain a key consideration for investigators and clinicians.