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Evidence-based guidelines for the pharmacological treatment of migraine, summary version
Ornello, Raffaele , Caponnetto, Valeria , Ahmed, Fayyaz , Al‐Khazali, Haidar M. , Ashina, Sait , Baraldi, Carlo , Bellotti, Alessia, Cevoli, Sabina , Cheng, Shuli, Chiarugi, Alberto , Christensen, Rune Häckert , Chu, Min Kyung , Crema, Santiago , Stefano, Vincenzo Di , Ekizoğlu, Esme , Fallacara, Adriana , Favoni, Valentina , Garces, Kimberly, Granato, Antonio, Granella, Franco, Ha, Woo‐Seok , Hirata, Koichi , Hoffmann, Jan , Hüssler, Eva-Maria, Hussein, Mona , Jenkins, Bronwyn , Labastida‐Ramírez, Alejandro , Laporta, Anna, Levin, Morris , Lupica, Antonino , Mampreso, Edoardo, Martinelli, Daniele , Orologio, Ilaria, Panneerchelvam, Lavindren Luke, Quattrocchi, Silvia, Romanenko, V.I. , Romozzi, Marina , Russo, Antonio , Sances, Grazia , Sarchielli, Paola , Silvestro, Marcello , Tassorelli, Cristina , Tessitore, Alessandro , Christensen, Rune H. , Ambrosini, Anna , Ashina, Sait , Baraldi, Carlo , Bellotti, Alessia , Casillo, Francesco , Cevoli, Sabina , Chiang, Chia-Chun , Chu, Min Kyung , Coppola, Gianluca , Corbelli, Ilenia , De Icco, Roberto , de Tommaso, Marina , Di Stefano, Vincenzo , Diener, Hans-Christoph , Ekizoglu, Esme , Fallacara, Adriana , Favoni, Valentina , Ha, Woo-Seok , Hassan, Amr , Hoffmann, Jan , Hussein, Mona , Iannone, Luigi Francesco , Martinelli, Daniele , Monteith, Teshamae S , Pan, Li-Ling Hope , Rozen, Todd D. , Souza, Marcio Nattan P , Pozo-Rosich, Patricia , Rainero, Innocenzo , Romanenko, Volodymyr , Romozzi, Marina , Russo, Antonio , Sances, Grazia , Schwedt, Todd J , Swerts, Diego Belandrino , Tassorelli, Cristina , Togha, Mansoureh , Vaghi, Gloria , Wang, Shuu-Jiun , Ashina, Messoud , Sacco, Simona , Ornello, Raffaele , Al-Khazali, Haidar M , Ahmed, Fayyaz , Brighina, Filippo , Calabresi, Paolo , Casillo, Francesco , Chiang, Chia‐Chun , Coppola, Gianluca , Lorenzo, Cherubino Di , Diener, Hans‐Christoph , Geppetti, Pierangelo , Goicochea, María Teresa , Guérzoni, Simona , Hassan, Amr , Huessler, Eva‐Maria , Monteith, Teshamae , Özge, Aynur , Peres, Mário Fernando Prieto , Pozo‐Rosich, Patricia , Prudenzano, Maria Pia , Quattrocchi, Silvia, Rainero, Innocenzo , Romozzi, Marina , Schwedt, Todd J. , Tessitore, Alessandro , Wang, Shuu‐Jiun , Ashina, Messoud , Sacco, Simona

Cephalalgia | April 25, 2025 | Volume: 45 | Issue: 4 | Pages: No page available

10.1177/03331024251321500 | PMID 40277321 Get It

We here present evidence-based guidelines for the pharmacological treatment of migraine. These guidelines, created by the Italian Society for the Study of Headache and the International Headache Society, aim to offer clear, actionable recommendations to healthcare professionals. They incorporate evidence-based recommendations from randomized controlled trials and expert-based opinions. The guidelines follow the GRADE approach for assessing the quality of evidence. The guideline development involved a systematic review of literature across multiple databases, adherence to Cochrane review methods, and a structured framework for data extraction and interpretation. Although the guidelines provide a robust foundation for migraine treatment, they also highlight gaps in current research, such as the paucity of head-to-head drug comparisons and the need for long-term outcome studies. These guidelines serve as a resource to standardize migraine treatment and promote high-quality care across different healthcare settings.
Evidence-based guidelines for the pharmacological treatment of migraine
Ornello, Raffaele , Caponnetto, Valeria , Ahmed, Fayyaz , Al‐Khazali, Haidar M. , Ashina, Sait , Baraldi, Carlo , Bellotti, Alessia, Cevoli, Sabina , Cheng, Shuli, Chiarugi, Alberto , Christensen, Rune Häckert , Chu, Min Kyung , Crema, Santiago , Stefano, Vincenzo Di , Ekizoğlu, Esme , Fallacara, Adriana , Favoni, Valentina , Garces, Kimberly, Granato, Antonio, Granella, Franco, Ha, Woo‐Seok , Hirata, Koichi , Hoffmann, Jan , Hüssler, Eva-Maria, Hussein, Mona , Jenkins, Bronwyn , Labastida‐Ramírez, Alejandro , Laporta, Anna, Levin, Morris , Lupica, Antonino , Mampreso, Edoardo, Martinelli, Daniele , Orologio, Ilaria, Panneerchelvam, Lavindren Luke, Quattrocchi, Silvia, Romanenko, V.I. , Romozzi, Marina , Russo, Antonio , Sances, Grazia , Sarchielli, Paola , Silvestro, Marcello , Tassorelli, Cristina , Tessitore, Alessandro , Christensen, Rune H. , Ashina, Sait , Baraldi, Carlo , Bellotti, Alessia , Casillo, Francesco , Chiang, Chia-Chun , Chu, Min Kyung , Coppola, Gianluca , Corbelli, Ilenia , De Icco, Roberto , de Tommaso, Marina , Di Stefano, Vincenzo , Diener, Hans-Christoph , Favoni, Valentina , Ha, Woo-Seok , Hoffmann, Jan , Hussein, Mona , Iannone, Luigi Francesco , Martinelli, Daniele , Monteith, Teshamae S , Pan, Li-Ling Hope , Rozen, Todd D. , Souza, Marcio Nattan P , Pozo-Rosich, Patricia , Rainero, Innocenzo , Romozzi, Marina , Russo, Antonio , Schwedt, Todd J , Swerts, Diego Belandrino , Tassorelli, Cristina , Togha, Mansoureh , Vaghi, Gloria , Wang, Shuu-Jiun , Ornello, Raffaele , Al-Khazali, Haidar M , Ahmed, Fayyaz , Ambrosini, Anna , Brighina, Filippo , Calabresi, Paolo , Casillo, Francesco , Chiang, Chia‐Chun , Coppola, Gianluca , Lorenzo, Cherubino Di , Diener, Hans‐Christoph , Geppetti, Pierangelo , Goicochea, María Teresa , Guérzoni, Simona , Hassan, Amr , Huessler, Eva‐Maria , Monteith, Teshamae , Özge, Aynur , Peres, Mário Fernando Prieto , Pozo‐Rosich, Patricia , Prudenzano, Maria Pia , Quattrocchi, Silvia, Rainero, Innocenzo , Romozzi, Marina , Schwedt, Todd J. , Tessitore, Alessandro , Wang, Shuu‐Jiun , Ashina, Messoud , Sacco, Simona

Cephalalgia | April 25, 2025 | Volume: 45 | Issue: 4 | Pages: No page available

10.1177/03331024241305381 | PMID 40277319 Get It

We here present evidence-based guidelines for the pharmacological treatment of migraine. These guidelines, created by the Italian Society for the Study of Headache and the International Headache Society, aim to offer clear, actionable recommendations to healthcare professionals. They incorporate evidence-based recommendations from randomized controlled trials and expert-based opinions. The guidelines follow the Grading of Recommendations, Assessment, Development and Evaluation approach for assessing the quality of evidence. The guideline development involved a systematic review of literature across multiple databases, adherence to Cochrane review methods, and a structured framework for data extraction and interpretation. Although the guidelines provide a robust foundation for migraine treatment, they also highlight gaps in current research, such as the paucity of head-to-head drug comparisons and the need for long-term outcome studies. These guidelines serve as a resource to standardize migraine treatment and promote high-quality care across different healthcare settings.
Setting higher standards for migraine prevention: A position statement of the International Headache Society
Sacco, Simona , Diener, Hans‐Christoph , Haghdoost, Faraidoon , Lee, Mi Ji , Monteith, Teshamae , Jenkins, Bronwyn , Peres, Mário Fernando Prieto , Pozo‐Rosich, Patricia , Ornello, Raffaele , Puledda, Francesca , Sakai, Fumihiko , Tassorelli, Cristina , Diener, Hans-Christoph , Haghdoost, Faraidoon , Lee, Mi Ji , Monteith, Teshamae S , Rozen, Todd D. , Pozo-Rosich, Patricia , Ornello, Raffaele , Puledda, Francesca , Schwedt, Todd J , Wang, Shuu-Jiun , Ahmed, Fayyaz , Tassorelli, Cristina , Sacco, Simona , Ashina, Messoud , Schwedt, Todd J. , Terwindt, Gisela M. , Vaghi, Gloria , Wang, Shuu‐Jiun , Ahmed, Fayyaz

Cephalalgia | February 21, 2025 | Volume: 45 | Issue: 2 | Pages: No page available

10.1177/03331024251320608 | PMID 39980456 Get It

Migraine is one of the most prevalent and disabling neurological diseases, significantly affecting quality of life and productivity, as well as contributing to substantial societal costs. Recent innovations, including calcitonin gene-related peptide (CGRP) pathway inhibitors and onabotulinumtoxinA, have transformed migraine prevention by offering high efficacy and excellent tolerability, thus improving adherence. Clinical trials and real-world studies show that significant reductions in migraine frequency and, in some cases, complete migraine freedom is achievable. In this Position Statement, we advocate for raising the standards of migraine prevention by setting ambitious treatment goals aimed at optimal outcomes, such as migraine freedom or very low number of days with migraine or moderate/severe headache. We emphasize the importance of addressing residual migraine burden, highlighting that achieving a ≥50% reduction in monthly migraine days, although often considered a successful response, may not fully restore quality of life. Relying solely on percentage-based improvements can obscure the persisting impact of residual burden. This Position Statement does not want to change the standards for clinical trials but aims primarily at real-world clinical practice and proposes a shift from percentage-based measures of success to absolute goals while on treatment. We outline a framework that categorizes outcomes into four tiers: migraine freedom (no days with migraine or moderate-to-severe headache), optimal control (less than four days with migraine or moderate-to-severe headache), modest control (four to six days with migraine or moderate-to-severe headache) and insufficient control (more than days with migraine or moderate-to-severe headache). Focusing on residual burden while on treatment aims to further improve patient quality of life and drive innovation in preventive therapies and non-pharmacological approaches. By advocating for higher standards, this Position Statement, is not aimed primarily to drive reimbursement policies for migraine preventive treatments, but seeks to inspire clinicians, researchers and policymakers to prioritize ambitious goals in migraine prevention, ultimately enhancing patient outcomes and reducing the broader societal and economic impact of this debilitating condition.
Similarities and differences in self-reported symptoms and comorbidities between hypermobile Ehlers–Danlos syndrome and hypermobility spectrum disorders
Darakjian, Ashley A. , Bhutani, Mira, Fairweather, DeLisa , Kocsis, S , Fliess, Jessica J. , Khatib, Sami , Weigel, Gabe J , McCabe, Elizabeth J , Balamurugan, Varsini, Perona, Evan E , Gehin, Jessica M. , Jain, Angita , Sledge, Hanna, Hodge, David O. , Rozen, Todd D. , Soyer, Ozan, Cheung, Joseph , Shirey, David, Gajarawala, Shilpa , Munipalli, Bala , Weigel, G. , Kocsis, S Christian, Whelan, Emily R. , Rozen, Todd D , Farraye, Francis A , Cheung, Joseph , Grach, Stephanie L , Gajarawala, Shilpa , Munipalli, Bala , Shufelt, Chrisandra L , Knight, Dacre R T , Bruno, Katelyn A , Fairweather, DeLisa , Bhutani, Mira, Farraye, Francis A. , Soyer, Ozan, Grach, Stephanie L. , Shufelt, Chrisandra , Bruno, Katelyn A.

Rheumatology Advances in Practice | December 10, 2024 | Volume: 8 | Issue: 4 | Pages: No page available

10.1093/rap/rkae134 | PMID 39660107 Get It

Abstract Objectives Patients with hypermobile Ehlers–Danlos syndrome (hEDS) and hypermobility spectrum disorders (HSD) experience a wide array of symptoms and system disorders. This study aimed to identify whether differences occurred in 115 self-reported symptoms and comorbidities in patients diagnosed with hEDS or HSD. Methods In this study we analysed self-reported data from an EDS Clinic intake questionnaire in patients diagnosed with hEDS, HSD or no hypermobile conditions. Results From 1 November 2019 to 7 March 2024, the EDS Clinic saw 2088 patients. Using the 2017 diagnostic criteria, 66.5% were diagnosed with HSD (n = 1389), 20.3% with hEDS (n = 423), 10.6% with historic HSD (H-HSD) or localized HSD (L-HSD) (n = 256) (hypermobile controls) and 2.6% were not diagnosed with hEDS, HSD, H-HSD or L-HSD (n = 55) (controls). Symptoms/comorbidities that occurred with high prevalence in both hEDS and HSD included joint pain (hEDS 82.0%, HSD 88.9%), allergy (hEDS 77.0%, HSD 77.0%), subluxations (hEDS 71.2%, HSD 72.6%), brain fog (hEDS 70.0%, HSD 74.7%), headache (hEDS 68.1%, HSD 69.1%), anxiety (hEDS 60.3%, HSD 69.3%), depression (hEDS 52.2%, HSD 58.0%), migraine (hEDS 53.7%, HSD 52.5%), nausea (hEDS 54.6%, HSD 59.5%) and constipation (hEDS 53.0%, HSD 57.2%). In contrast, 9/115 (8%) symptoms/comorbidities were self-reported significantly more often in hEDS but 42/115 (37%) in HSD. hEDS patients reported more symptoms that suggest a defect in collagen, such as dislocation, hernias and rectal prolapse, while HSD patients reported more joint, muscle, allergy, neurological, gastrointestinal, sleep and psychological symptoms/comorbidities. Conclusion Although we found an overlap in some symptoms and comorbidities self-reported by hEDS/HSD patients, such as allergy/atopy, headache/migraine and gastrointestinal symptoms, our findings suggest key differences exist between the two diagnoses, suggesting that hEDS and HSD may be distinct conditions.
International Headache Society global practice recommendations for the acute pharmacological treatment of migraine
Puledda, Francesca , Diener, Hans‐Christoph , Al‐Khazali, Haidar M. , Ashina, Sait , Liebler, Eric , Chu, Min Kyung , Cocores, Alexandra, Dodd-Glover, Freda , Ekizoğlu, Esme , Göbel, Carl, Hassan, Amr , Hirata, Koichi , Hoffmann, Jan , Jenkins, Bronwyn , Kamm, Katharina , Martinelli, Daniele , Monteith, Teshamae , Romanenko, V.I. , Vandenbussche, Nicolas , Tassorelli, Cristina , Diener, Hans-Christoph , Ashina, Sait , Chu, Min Kyung , Garcia-Azorin, David , Hoffmann, Jan , Kamm, Katharina , Lee, Mi Ji , Ling, Yu-Hsiang , Martinelli, Daniele , Monteith, Teshamae S , Ornello, Raffaele , Rozen, Todd D. , Pozo-Rosich, Patricia , Souza, Marcio Nattan P , Thuraiaiyah, Janu , Togha, Mansoureh , Wang, Shuu-Jiun , Yu, Shengyuan , Tassorelli, Cristina , Al-Khazali, Haidar M , Puledda, Francesca , Hassan, Amr , Sacco, Simona , Ashina, Messoud , Burstein, Rami , Cipriani, Andrea , Göbel, Carl Hartmut , Goicochea, María Teresa , Lee, Mi Ji , Lisicki, Marco , Ornello, Raffaele , Özge, Aynur , Peres, Mário Fernando Prieto , Pozo‐Rosich, Patricia , Schwedt, Todd J. , Takizawa, Tsubasa , Terwindt, Gisela M. , Wang, Shuu‐Jiun

Cephalalgia | August 12, 2024 | Volume: 44 | Issue: 8 | Pages: No page available

10.1177/03331024241252666 | PMID 39133176 Get It

Background In an effort to improve migraine management around the world, the International Headache Society (IHS) has here developed a list of practical recommendations for the acute pharmacological treatment of migraine. The recommendations are categorized into optimal and essential, in order to provide treatment options for all possible settings, including those with limited access to migraine medications. Methods An IHS steering committee developed a list of clinical questions based on practical issues in the management of migraine. A selected group of international senior and junior headache experts developed the recommendations, following expert consensus and the review of available national and international headache guidelines and guidance documents. Following the initial search, a bibliography of twenty-one national and international guidelines was created and reviewed by the working group. Results A total of seventeen questions addressing different aspects of acute migraine treatment have been outlined. For each of them we provide an optimal recommendation, to be used whenever possible, and an essential recommendation to be used when the optimal level cannot be attained. Conclusion Adoption of these international recommendations will improve the quality of acute migraine treatment around the world, even where pharmacological options remain limited.
Onabotulinumtoxina (craniotomy scar combined with cranial suture line injections) for persistent post craniotomy headache: Case series with long-term follow-up
Leon, Janet, Rozen, Todd D. , Bhatt, Alok A. , Bhatt, Alok A

Cephalalgia | June 13, 2024 | Volume: 44 | Issue: 6 | Pages: No page available

10.1177/03331024241259452 | PMID 38870368 Get It

Background There is no defined preventive treatment protocol for persistent post-craniotomy headache. In several small case series and individual case reports onabotulinumtoxinA injected into the craniotomy scar has shown possible efficacy. What is lacking is long term follow-up and if focusing on the cranial suture lines along with the craniotomy scar can enhance improvement and provide more sustained benefit. Methods Retrospective chart review with case series. Results Four patients (three women, one man) with ICHD-3 defined persistent post craniotomy headache were treated using a novel onabotulinumtoxinA injection protocol. All the patients presented with continuous head pain of moderate to severe intensity. All had severe allodynia on the side of their craniotomy. All had significant reduction in quality of life. Our application of onabotulinumtoxinA involved injection into both the surgical scar and the transected/irritated cranial suture lines noted on neuroimaging and physical examination. With treatment all patients demonstrated significant benefit including a reduction in daily pain intensity (75%-100%), developing periods of pain freedom (2–7 days per week) and having a dramatic improvement in quality of life (close to 100% in all). The benefit was sustained for at least five years of follow-up. Conclusion From our case series it appears that injection not only along the painful craniotomy scar but into the involved cranial suture lines provides positive efficacy and sustained improvement in patients with persistent post craniotomy headache.
Family with brain calcification and SLC20A2 variant – possible anticipation (P6.051)
Blackburn, Patrick R. , Rozen, Todd D. , Gerpen, Jay Van, Konno, Takuya , Gerpen, Jay A. van, Ross, Owen A. , Atwal, Paldeep S , Wszołek, Zbigniew K.

Neurology | December 7, 2023 | Volume: 90 | Issue: 15_supplement | Pages: No page available

10.1212/wnl.90.15_supplement.p6.051 Get It

A Cluster Headache Phenotype (Never Smoker and No Parental Secondary Smoke Exposure as a Child): Results from the United States Cluster Headache Survey (P3.122)
Rozen, Todd D.

Neurology | December 7, 2023 | Volume: 90 | Issue: 15_supplement | Pages: No page available

10.1212/wnl.90.15_supplement.p3.122 Get It

The Inverse Relationship Between Cerebral Microbleed Burden and Migraine-Related Disability in CADASIL (S40.004)
Klaas, James P. , Lesser, Elizabeth R. , Hodge, David O. , Brown, Robert D. , Rozen, Todd D. , Capobianco, David J., Huang, Josephine F. , Goldstein, Eric , Badi, Mohammed K. , Dodick, David W. , Lin, Michelle , Meschia, James F.

Neurology | December 7, 2023 | Volume: 92 | Issue: 15_supplement | Pages: No page available

10.1212/wnl.92.15_supplement.s40.004 Get It