HeadachePub Date : 2024-11-27DOI: 10.1111/head.14870
Anjeli Song, Joseph E Safdieh, Matthew S Robbins
{"title":"Group text messaging as a residency teaching tool in outpatient neurology and headache: A mixed-methods observational study.","authors":"Anjeli Song, Joseph E Safdieh, Matthew S Robbins","doi":"10.1111/head.14870","DOIUrl":"https://doi.org/10.1111/head.14870","url":null,"abstract":"<p><strong>Objective: </strong>To assess the feasibility and efficacy of group text messaging as a teaching tool to improve neurology resident knowledge and clinical pearl dissemination in an outpatient setting enriched with headache encounters, and to evaluate if learning points from this teaching method would influence resident care of subsequent patients.</p><p><strong>Background: </strong>Inpatient neurology teaching during training is most often accomplished in team settings during rounds or conferences such as morning report, but outpatient teaching where headache is more likely encountered may be less consistently performed in such a setting where learning points may be shared. Few studies have evaluated whether group text messaging can be an innovative tool for teaching in residency training.</p><p><strong>Methods: </strong>Neurology residents in a continuity clinic pod at New York Presbyterian-Weill Cornell were included in this cohort from December 2020 through March 2024. Group text messages deidentified of any patient information were sent to the resident pod by their preceptor after each clinic session featuring one text message regarding a takeaway learning point pertaining to each patient encounter. Residents were surveyed on their satisfaction with this teaching method and whether these text messages improved their outpatient neurology knowledge.</p><p><strong>Results: </strong>A total of 230 text messages were sent to a cohort of 21 residents across 4 academic years. Text message topics covered a variety of neurological subspecialties, most commonly headache and facial pain (44.8%), general neurology (15.7%), and neuromuscular (14.3%). In our survey, 93% of resident respondents reported that receiving clinical pearls improved their outpatient neurology knowledge and changed how they cared for subsequent patients.</p><p><strong>Conclusion: </strong>Reinforcement of traditionally one-on-one learning points in a teaching outpatient setting to engage a group of residents was feasible across visit types. There was an overall very positive response to this teaching method, and residents reported improved knowledge, which influenced their care of subsequent patients.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142728037","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
HeadachePub Date : 2024-11-27DOI: 10.1111/head.14874
Mona Hussein, Amr Hassan, Mona A F Nada, Zeinab Mohammed, Wael Fathy, Nawal F Abdel Ghaffar, Hanaa Kedah, Rehab Magdy
{"title":"Validity, reliability, and sensitivity to change of the Arabic version of the Migraine-Specific Quality-of-Life Questionnaire after prophylactic treatment.","authors":"Mona Hussein, Amr Hassan, Mona A F Nada, Zeinab Mohammed, Wael Fathy, Nawal F Abdel Ghaffar, Hanaa Kedah, Rehab Magdy","doi":"10.1111/head.14874","DOIUrl":"https://doi.org/10.1111/head.14874","url":null,"abstract":"<p><strong>Background: </strong>The Migraine-Specific Quality-of-Life Questionnaire version 2.1 (MSQ 2.1) is one of the most frequently used tools in assessing the impact of migraine in clinical practice and in migraine research. This work aimed to examine the reliability and validity of the Arabic version of the MSQ 2.1 in Arabic-speaking patients with migraine and to assess its ability to detect subtle changes in quality of life after receiving prophylactic migraine medications.</p><p><strong>Methods: </strong>This multicenter prospective observational study was conducted with 140 patients experiencing migraine and indicated for prophylactic medications. Headache assessment was done at baseline and 3 months after receiving prophylactic medications using the Arabic version of MSQ 2.1, Headache Impact Test (HIT-6), and visual analog scale (VAS). The MSQ 2.1 was repeated 1 week after the first visit to a group of patients (n = 70) to assess test-retest reliability.</p><p><strong>Results: </strong>Cronbach's alpha for the MSQ 2.1 was 0.973, indicating excellent internal consistency. The intraclass correlation coefficient (average measure) was 0.99, indicating excellent test-retest reliability. There were statistically significant correlations between the MSQ 2.1 total score and monthly migraine days, VAS, and HIT-6 scores before and 3 months after prophylactic medications. The receiver operating characteristic curve revealed that an increase of 8.5 in the total score of the MSQ 2.1 represents the minimally important change that means significant improvement (area under the curve = 0.785, sensitivity = 0.861, specificity = 0.656, p < 0.001).</p><p><strong>Conclusion: </strong>The Arabic version of the MSQ 2.1 is a valid, reliable, and sensitive tool that can precisely assess the impact of migraine on quality of life.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142727989","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Occipital neuralgia as an initial manifestation of atypical Lemierre syndrome: A case report.","authors":"Akira Hanazono, Keita Yasuda, Atsuyoshi Nagata, Toshiharu Kitamura, Masashiro Sugawara","doi":"10.1111/head.14876","DOIUrl":"https://doi.org/10.1111/head.14876","url":null,"abstract":"<p><p>Lemierre syndrome is a life-threatening but treatable septic thrombosis of the internal jugular vein (IJV) derived from a craniocervical bacterial infection. Metastatic septic embolization is common. However, diagnostic delay and poor prognosis remain a problem, largely due to the diverse clinical presentations and unclear symptomatology of Lemierre syndrome. In contrast, occipital neuralgia is a common disease typically treated with symptomatic therapy in emergency settings, as most cases are not life-threatening. The present case involved a 70-year-old female with Lemierre syndrome stemming from Streptococcus anginosus infection originating in sinusitis or periodontitis. The onset was characterized by headache with typical occipital neuralgia, a severe trigger point in the posterior neck ipsilateral to the infected IJV, and reduced sensation of the C2 nerve root area. Given the anatomical relationship of the cranial venous emissary system into the posterior cervical venous plexus, the case highlights the potential for the neighboring occipital nerve to be directly involved in Lemierre syndrome. Interestingly, despite Lemierre syndrome typically arising from pharyngeal bacterial infections and infected IJV located in the \"anterior\" neck, many prior case reports have described \"occipital\" or \"posterior\" pain at the head or neck. History taking and physical examination remain essential to identify the causes of these posterior/occipital symptoms, since imaging investigations, as in this case, often fail to identify them. Early recognition of occipital neuralgia as a potential initial symptom of Lemierre syndrome could lead to earlier diagnosis and treatment, potentially improving patient outcomes.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142686899","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
HeadachePub Date : 2024-11-22DOI: 10.1111/head.14872
Pooja Patel, Swati Singh, Pengfei Zhang, Shelly Rishty, Shuwei Wang
{"title":"Headaches in Sjogren's disease: A narrative review.","authors":"Pooja Patel, Swati Singh, Pengfei Zhang, Shelly Rishty, Shuwei Wang","doi":"10.1111/head.14872","DOIUrl":"https://doi.org/10.1111/head.14872","url":null,"abstract":"<p><strong>Objective: </strong>To review the most common types of primary and secondary headaches that are associated with Sjogren's disease (SjD).</p><p><strong>Background: </strong>Sjogren's disease is a chronic systemic autoimmune disease that typically presents with xerophthalmia, xerostomia, and arthralgias. Sensory and motor neuropathies are commonly reported neurological complications with SjD. Primary and secondary headaches are also frequent neurological complications associated with SjD, which may be under-recognized.</p><p><strong>Methods: </strong>In this study, researchers conducted a literature review through the platforms of PubMed and Google Scholar with the keywords: (1) Sjogren's syndrome, (2) Sjogren's disease, (3) headache, (4) migraine, (5) tension-type headache, (6) aseptic meningitis, (7) cerebral venous sinus thrombosis, and (8) idiopathic intracranial hypertension. Included articles involved a study population of patients with both SjD and headache. There were no exclusion criteria. A total of 54 articles were identified, and 31 articles were utilized for study analysis.</p><p><strong>Results: </strong>In patients with SjD, headaches were a frequently reported neurological complaint. The most common types of primary headaches associated with SjD were found to be migraine and tension-type headache. Patients with SjD were more likely to report severe, debilitating headaches compared to the general population. Furthermore, patients with SjD have been found to experience dangerous types of secondary headaches, including aseptic meningitis and cerebral venous sinus thrombosis.</p><p><strong>Conclusions: </strong>Headaches are a common neurological complication in patients with SjD. Current literature suggests that there is an increased risk of both primary and secondary headaches in individuals with SjD compared to the general population and that headaches may occur throughout the clinical course of the disease. There are also reports of patients who experience the onset of primary and secondary headaches prior to the diagnosis of SjD. SjD has been linked to dangerous, life-threatening conditions that cause headaches, which require urgent recognition and treatment. Therefore, it is important to have a higher index of suspicion for patients who present with headaches and clinical symptoms of SjD, such as xerophthalmia and xerostomia. Utilizing a detailed history, physical examination, and neuroimaging can assist clinicians to recognize and diagnose types of headaches in patients with SjD to prevent dangerous complications.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142686896","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
HeadachePub Date : 2024-11-21DOI: 10.1111/head.14871
Jessica Ailani, Richard B Lipton, Andrew M Blumenfeld, Laszlo Mechtler, Brad C Klein, Molly Yizeng He, Jonathan H Smith, Joel M Trugman, Rosa de Abreu Ferreira, Elimor Brand-Schieber
{"title":"Safety and tolerability of ubrogepant for the acute treatment of migraine in participants taking atogepant for the preventive treatment of episodic migraine: Results from the TANDEM study.","authors":"Jessica Ailani, Richard B Lipton, Andrew M Blumenfeld, Laszlo Mechtler, Brad C Klein, Molly Yizeng He, Jonathan H Smith, Joel M Trugman, Rosa de Abreu Ferreira, Elimor Brand-Schieber","doi":"10.1111/head.14871","DOIUrl":"https://doi.org/10.1111/head.14871","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the safety and tolerability of ubrogepant for the acute treatment of migraine in participants taking atogepant for the preventive treatment of episodic migraine (EM).</p><p><strong>Background: </strong>Atogepant is an oral calcitonin gene-related peptide (CGRP) receptor antagonist approved for the preventive treatment of migraine in adults and ubrogepant is an oral CGRP receptor antagonist approved for the acute treatment of migraine in adults, with or without aura. The safety and tolerability of the concomitant use of ubrogepant and atogepant have not been previously evaluated in a clinical setting.</p><p><strong>Methods: </strong>The TANDEM study, a phase 4, two-period, multicenter, open-label study conducted in the United States, enrolled adults with migraine, with or without aura, and <15 headache days/month. In Treatment Period 1, participants took atogepant 60 mg once daily (QD) for 12 weeks and their own non-gepant acute headache medication for breakthrough migraine attacks. In Treatment Period 2, participants continued taking atogepant 60 mg QD and ubrogepant 100 mg was taken as needed (PRN) for the treatment of breakthrough migraine attacks (up to eight per 4-week interval) for 12 weeks. In Treatment Period 2, an optional second ubrogepant dose or the participant's own acute medication could be used to rescue headaches that did not resolve within 2-24 h post initial ubrogepant dose. The primary objective evaluated the safety and tolerability of the concomitant use of ubrogepant and atogepant.</p><p><strong>Results: </strong>Of 263 participants enrolled, 262 were treated in Treatment Period 1 (Safety Population 1) and 218 continued and were treated in Treatment Period 2 (Safety Population 2). The mean (standard deviation) number of ubrogepant use days in Treatment Period 2 was 6.6 (5.03) over the 12 weeks. In Treatment Periods 1 and 2, 49.6% and 43.1% of participants experienced a treatment-emergent adverse event (TEAE), respectively. The most common TEAEs (≥5%) in Treatment Period 1 and Treatment Period 2 were COVID-19 (8.4%, 3.2%), fatigue (6.5%, 1.4%), nausea (6.1%, 0.9%), decreased appetite (5.7%, 0.9%), and constipation (5.3%, 0.9%). In Treatment Period 2, no increase in the incidence and types of TEAEs in relation to the number of ubrogepant use days or doses taken were identified. During the whole treatment period, 9.9% of participants discontinued atogepant or ubrogepant treatment due to TEAEs. There was one serious TEAE in Treatment Period 1 (ureterolithiasis) and one in Treatment Period 2 (cervical myelopathy), and both were considered not related to study treatment by the study investigators.</p><p><strong>Conclusion: </strong>The use of atogepant 60 mg QD for the preventive treatment of EM and ubrogepant 100 mg PRN for the acute treatment of migraine over the 12-week open-label concomitant use treatment period was safe and well tolerated. The overall safety results were consistent wit","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2024-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142681698","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
HeadachePub Date : 2024-11-15DOI: 10.1111/head.14849
Christina Murphy, Ali Ladak, Christina L Szperka, Blanca Marquez De Prado, Andrew D Hershey, Carlyn Patterson Gentile
{"title":"Anxiety, depression, and headache-related disability in a large pediatric clinic-based sample.","authors":"Christina Murphy, Ali Ladak, Christina L Szperka, Blanca Marquez De Prado, Andrew D Hershey, Carlyn Patterson Gentile","doi":"10.1111/head.14849","DOIUrl":"https://doi.org/10.1111/head.14849","url":null,"abstract":"<p><strong>Objective: </strong>To explore the relationships among anxiety, depression, and headache-related disability in a pediatric clinic-based retrospective cross-sectional study.</p><p><strong>Background: </strong>Anxiety and depression are commonly considered comorbidities of headache disorders and are frequently seen in children and adolescents. These conditions can contribute to disability and may have a cumulative impact. In this study, we tested whether self-reported anxiety and/or depression in youth were associated with headache-related disability.</p><p><strong>Methods: </strong>This was a retrospective cross-sectional study of children ages 6-17 years old who completed a headache intake questionnaire at the time of a new outpatient neurology visit. Those who reported on behavioral health symptoms, involvement of a behavioral health provider (i.e., yes/no), and the PedMIDAS (a validated metric of headache-related disability) were included. The relationship between anxiety and/or depression and headache-related disability was examined.</p><p><strong>Results: </strong>Of the 12,660 questionnaires queried, 9118 met criteria for inclusion. Respondents were 64.0% female and had a median age of 13.5 years (interquartile range [IQR] 10.3, 15.7). Compared to patients without self-reported anxiety/depression, patients with anxiety and depression reported higher headache-related disability (M = 17.0, [IQR 6.0, 41.0]) even after accounting for covariates (estimated difference = 6.0, 95% confidence interval [CI: 4.4-7.5]). For participants with anxiety and/or depression, having a behavioral health provider was associated with greater headache-related disability (estimated difference = 7.0; 95% CI 4.6-9.3).</p><p><strong>Conclusions: </strong>Patients with self-reported anxiety and/or depression reported higher headache-related disability. Having a behavioral health provider was associated with greater headache-related disability, indicating the complexity and high level of need for this population. Further research is needed to understand the directionality of these results; however, patients with headache as well as depression and or anxiety are a vulnerable group who may benefit from an integrated care model.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142638685","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
HeadachePub Date : 2024-11-10DOI: 10.1111/head.14867
Raghavan Gopalakrishnan, Nitesh Singh Malan, Nymisha Mandava, Eric J Dunn, Neil Nero, Richard C Burgess, MaryAnn Mays, Olivia Hogue
{"title":"Magnetoencephalography studies in migraine and headache disorders: A systematic review.","authors":"Raghavan Gopalakrishnan, Nitesh Singh Malan, Nymisha Mandava, Eric J Dunn, Neil Nero, Richard C Burgess, MaryAnn Mays, Olivia Hogue","doi":"10.1111/head.14867","DOIUrl":"https://doi.org/10.1111/head.14867","url":null,"abstract":"<p><strong>Background: </strong>Understanding the neural mechanisms underlying migraine and other primary headache disorders is critical for the development of long-term cures. Magnetoencephalography (MEG), an imaging modality that measures neuronal currents and cortical excitability with high temporal and superior spatial resolution, has been increasingly used in neurological research. Initial MEG studies showed promise in directly recording cortical spreading depression-a cortical correlate of migraine with aura. However, lately MEG technology has highly evolved with greater potential to reveal underlying pathophysiology of migraine and primary headache disorders, and aid in the identification of biomarkers.</p><p><strong>Objective: </strong>To systematically review the use of MEG in migraine and other primary headache disorders and summarize findings.</p><p><strong>Methods: </strong>We conducted a systematic search and selection of MEG studies in migraine and primary headache disorders from inception until June 8, 2023, in Medline, Embase, Cochrane, and Scopus databases. Peer-reviewed English articles reporting the use of MEG for clinical or research purposes in migraine and primary headache disorders were selected.</p><p><strong>Results: </strong>We found 560 articles and included 38 in this review after screening. Twelve studies investigated resting-state, while others investigated a sensory modality using an evoked or event-related paradigm with a total of 35 cohort and 3 case studies. Thirty-two studies focused exclusively on migraine, while the rest reported other primary headache disorders.</p><p><strong>Conclusion: </strong>The findings show an evolution of MEG from a 7- to a 306-channel system and analysis evolving from sensor-level evoked responses to more advanced source-level connectivity measures. A relatively few MEG studies portrayed migraine and primary headache disorders as a sensory abnormality, especially of the visual system. We found heterogeneity in the datasets, data reporting standards (due to constantly evolving MEG technology and analysis methods), and patient characteristics. Studies were inadequately powered and there was no evidence of blinding procedures to avoid selection bias in case-control studies, which could have led to false-positive findings. More studies are needed to investigate the affective-cognitive aspects that exacerbate pain and disability in migraine and primary headache disorders.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2024-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142618745","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
HeadachePub Date : 2024-11-10DOI: 10.1111/head.14868
Arão Belitardo de Oliveira, Mario Fernando Prieto Peres, Juliane Prieto Peres Mercante, André R Brunoni, Yuan-Pang Wang, Maria Del Carmen B Molina, Lucas K Uchiyama, Paulo A Lotufo, Isabela M Benseñor, Alessandra C Goulart
{"title":"Associations of comorbid headache disorders and depression with leisure-time physical activity among 14,088 adults in The Brazilian Longitudinal Study of Adult Health.","authors":"Arão Belitardo de Oliveira, Mario Fernando Prieto Peres, Juliane Prieto Peres Mercante, André R Brunoni, Yuan-Pang Wang, Maria Del Carmen B Molina, Lucas K Uchiyama, Paulo A Lotufo, Isabela M Benseñor, Alessandra C Goulart","doi":"10.1111/head.14868","DOIUrl":"https://doi.org/10.1111/head.14868","url":null,"abstract":"<p><strong>Background: </strong>While headache disorders are linked to low physical activity levels, the impact of depression on this relationship is unclear.</p><p><strong>Objective: </strong>To assess how single and comorbid diagnoses of migraine and tension-type headache (TTH) interact with depression and leisure-time physical activity (LTPA) levels in The Brazilian Longitudinal Study of Adult Health (ELSA-Brasil).</p><p><strong>Methods: </strong>In this cross-sectional analysis based on the ELSA-Brasil baseline data, the relationship of migraine, TTH (both assessed with the International Classification of Headache Disorders, Second Edition), and depression (assessed with the Clinical Interview Schedule-Revised) with LTPA levels (International Physical Activity Questionnaire) was investigated by employing linear regression models. Models were adjusted for sociodemographic, lifestyle, and clinical covariates, and interaction terms were created to examine additive effects of comorbid conditions.</p><p><strong>Results: </strong>Among 14,088 participants, 54.4% (7668/14,088) were female, prevalence rates were: TTH = 39.6% (5573/14,088), migraine = 27.0% (3806/14,088), depression = 0.7% (94/14,088), depression + TTH = 1.1% (148/14,088), and depression + migraine = 2.5% (356/14,088). The mean (standard deviation) LTPA levels across the groups were: no headache + no depression = 148.7 (183.0) min/week, TTH = 133.5 (170.1) min/week, migraine = 110.3 (154.8) min/week, depression = 76.5 (146.3) min/week, depression + TTH = 84.5 (127.7) min/week, and depression + migraine = 64.3 (123.2) min/week. Negative associations were found for depression (β = -55.1, 95% confidence interval [CI] -93.6 to -17.0; p = 0.005), migraine (β = -24.7, 95% CI -33.2 to -15.4; p < 0.001), and TTH (β = -15.5, 95% CI -23.1 to -7.6; p < 0.001) with LTPA. No interaction effect was observed for depression + TTH (β = 36.0, 95% CI -12.6 to 84.6; p = 0.147) and depression + migraine (β = 31.7, 95% CI -11.3 to 74.7; p = 0.149), indicating no additive effect of comorbid conditions on LTPA levels. After adjusting for headache attack frequency, only depression + migraine remained negatively associated with LTPA (β = -38.7, 95% CI -71.6 to -5.8; p = 0.021).</p><p><strong>Conclusions: </strong>Headache disorders and depression were independently and inversely associated with LTPA, with the strongest effects seen in depression alone or comorbid with migraine.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2024-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142618744","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
HeadachePub Date : 2024-11-07DOI: 10.1111/head.14856
Richard J Bertz, Julie L Collins, Jennifer Madonia, Rajinder Bhardwaj, Lisa Kamen, Kyle T Matschke, Jing Liu
{"title":"Comparative bioavailability of single-dose zavegepant during and between migraine attacks: A phase 1, randomized, open-label, fixed-sequence, two-period study.","authors":"Richard J Bertz, Julie L Collins, Jennifer Madonia, Rajinder Bhardwaj, Lisa Kamen, Kyle T Matschke, Jing Liu","doi":"10.1111/head.14856","DOIUrl":"https://doi.org/10.1111/head.14856","url":null,"abstract":"<p><strong>Objective: </strong>To compare the rate and extent of absorption of zavegepant 10 mg (therapeutic dose) or 20 mg (supratherapeutic dose) nasal spray during a migraine attack versus non-migraine period, assess safety, and explore efficacy and the relationship between zavegepant concentration and therapeutic response.</p><p><strong>Background: </strong>Physiologic changes occurring during a migraine attack could affect the pharmacokinetics of treatments for migraine.</p><p><strong>Methods: </strong>This was a Phase 1, multicenter, open-label, randomized, single-dose, two-period, fixed-sequence, comparative bioavailability study. Participants with a history of 2-8 migraine attacks per month of moderate or severe pain intensity were randomized to a single dose of zavegepant 10 or 20 mg, administered intranasally during a migraine attack (Period 1) and in a non-migraine period (Period 2). Blood samples were collected pre-dose and at pre-specified intervals up to 24 h post-dose for plasma zavegepant concentration measurement. Safety was monitored throughout, and efficacy (migraine pain intensity score, nausea, photophobia, phonophobia, aura, and functional disability) assessed during Period 1. Plasma zavegepant pharmacokinetic parameters were calculated by standard noncompartmental methods, including maximum plasma concentration (C<sub>max</sub>), area under plasma concentration-time curve from time zero to infinity (AUC<sub>0-inf</sub>), and time of C<sub>max</sub> (T<sub>max</sub>).</p><p><strong>Results: </strong>A total of 37 participants were evaluable for pharmacokinetics. Following administration of zavegepant 10 mg, geometric mean ratios for Period 1/Period 2 were 82.8% (90% confidence interval [CI] 60.5-113.2) for C<sub>max</sub> and 90.1% (90% CI 70.2-115.5) for AUC<sub>0-inf</sub>. Following administration of zavegepant 20 mg, geometric mean ratios for Period 1/Period 2 were 72.5% (90% CI 57.9-90.8) for C<sub>max</sub> and 73.4% (90% CI 58.8-91.7) for AUC<sub>0-inf</sub>. Averaging over the study period, geometric mean ratios for zavegepant 20 mg/10 mg were 142.5% (90% CI 118.6-171.4) for C<sub>max</sub> and 157.0% (90% CI 133.6-184.5) for AUC<sub>0-inf</sub>. Median T<sub>max</sub> was 0.5 h for both doses regardless of Period. Zavegepant was well tolerated in both study periods and effective during Period 1 at both dose levels. There was no apparent correlation between concentration at 0.5 h or 2 h post-dose and efficacy outcomes.</p><p><strong>Conclusion: </strong>Zavegepant exposure was comparable during a migraine attack and a non-migraine period, particularly at the therapeutic dose of 10 mg. When averaging over migraine and non-migraine periods, there was a less-than-dose proportional increase in zavegepant exposure when the dose was doubled from 10 to 20 mg. The median T<sub>max</sub> was 0.5 h regardless of migraine attack or dose. Zavegepant 10 and 20 mg exhibited favorable safety profiles during migraine attacks and non","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142604400","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}