Headache最新文献

{"title":"Case report: Prophylactic administration of verapamil for cluster headache during the pre-episode symptoms phase.","authors":"Yajin Wu, Mingjie Zhang, Zhao Dong, Shengyuan Yu","doi":"10.1111/head.15008","DOIUrl":"10.1111/head.15008","url":null,"abstract":"<p><strong>Background: </strong>As the first-line preventive treatment of cluster headache (CH), verapamil provides less relief in the initial stage of medication and takes 2-3 weeks to achieve optimal efficacy. Approximately one third of patients with CH have symptoms before the cluster period arrives, such as local pain, sensory abnormalities, and autonomic symptoms, which are called pre-episode symptoms (PES); however, no study has examined the role of prophylactic administration during this period.</p><p><strong>Case: </strong>Here, we report a patient with CH who was treated with verapamil at the beginning of the PES phase five times over 5 years to avoid the onset of CH. Unfortunately, CH recurred after the latest PES phase due to delayed treatment.</p><p><strong>Conclusion: </strong>Prophylactic treatment in the PES phase of CH might reduce the severity or prevent the onset of headache during the episode phase, suggesting the feasibility of initiating prophylactic treatment in the PES phase. A large clinical trial is necessary to verify this.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":"65 8","pages":"1492-1494"},"PeriodicalIF":4.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145124533","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":"Headache in transgender men using gender-affirming hormone therapy: A case-control study.","authors":"Erik Trovão Diniz, Jardelina Brena Rocha Leite, Camila Ribeiro Coutinho Madruga, Vitor Maia Arca, João Augusto Macedo Cavalcanti Albuquerque, Pedro Augusto Sampaio Rocha-Filho","doi":"10.1111/head.14944","DOIUrl":"10.1111/head.14944","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to compare the frequency, characteristics, and impact of primary headaches in transgender men (TM), cisgender men (CM), and cisgender women (CW).</p><p><strong>Background: </strong>Gender is a social construct shaped by roles and norms and influenced by cultural and environmental factors. Studies on primary headaches typically only consider sex and generally overlook gender.</p><p><strong>Methods: </strong>This was a case-control study conducted at the Hospital das Clínicas, Universidade Federal de Pernambuco, Brazil. A pilot study comparing 25 TM and 25 CM individuals was conducted to determine sample size requirements. After that, 50 TM (cases), 50 CM (controls), and 50 CW (controls) were included. The controls were age matched to cases. A semi-structured questionnaire, the six-item Headache Impact Test (HIT-6), and the Hospital Anxiety and Depression Scale were used. Data collection occurred from April 2022 to November 2023.</p><p><strong>Results: </strong>All the TM were taking gender-affirming hormone therapy (testosterone cypionate, 41; testosterone undecanoate/undecylenate, six; testosterone esters, three). According to the sample size calculation, adequate power was only achieved for the frequency of tension-type headache (TTH) and for headache impact. No differences were observed between TM and CW in the frequency of migraine (odds ratio [OR] 1.14, 95% confidence interval [CI] 0.45-2.91), TTH (OR 0.74, 95% CI 0.28-1.96), or headache severity (frequency ≥8 days/month: OR 0.54; 95% CI 1.18-1.63; moderate/severe intensity: OR 1.24, 95% CI 0.49-3.18; HIT-6 score ≥56 points: OR 0.66, 95% CI 0.25-1.75) (OR adjusted for higher education and depression by conditional logistic regression). The TM group exhibited significantly lower rates of all types of headache (OR 0.20, 95% CI 0.05-0.85) and TTH (OR 0.18, 95% CI 0.07-0.45) and a significantly higher prevalence of any migraine (OR 3.93, 95% CI 1.60-9.63) and migraine without aura (OR 3.12, 95% CI 1.10-8.84) compared to the CM group (OR adjusted for anxiety and depression by conditional logistic regression). There were no differences between TM and CM in headache severity (frequency, intensity, and impact).</p><p><strong>Conclusions: </strong>There are no differences in the headache type or severity between the TM and CW groups. TM have a higher prevalence of migraine than CM, but no difference in headache severity.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"1449-1456"},"PeriodicalIF":4.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143994339","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":"Quantitative analysis of thecal sac volume and morphology as a diagnostic tool in intracranial hypotension.","authors":"Kerry Knievel, Lea Alhilali, Raza Mushtaq, Kelly McCormick, Rachel Stancl, Karissa Secora, Jennifer Robblee","doi":"10.1111/head.15014","DOIUrl":"10.1111/head.15014","url":null,"abstract":"<p><strong>Objectives/background: </strong>This study was undertaken to determine whether thecal sac volume and morphometry can be used to differentiate patients with spontaneous intracranial hypotension (SIH). The mechanisms underlying SIH appear to be multifactorial. Association with connective tissue disorders is established, suggesting that increased thecal sac compliance and volume may contribute to SIH.</p><p><strong>Methods: </strong>This study is an observational cross-sectional study that used magnetic resonance imaging (MRI) to compare thecal sac volume between patients with SIH and healthy controls. Patients with SIH and matched controls were prospectively recruited from December 1, 2020 to March 1, 2022. All participants underwent volumetric MRI of the entire spine. Semiautomated segmentation was used to extract three-dimensional volumetric models of the thecal sac. A single average thecal sac model was created for each group. Signed model to model distance function was used to compute and visualize the correspondent vectors that quantify the localized differences, including shape, between control and SIH thecal sacs.</p><p><strong>Results: </strong>Twenty-eight patients with SIH (mean age = 45.9 years, mean body mass index = 27.7, 57% male) and 28 controls (mean age = 44.4 years, mean body mass index = 26.8, 57% male) were recruited. The thecal sac was significantly larger in patients with SIH (mean = 131.7 cm³, 95% confidence interval [CI] = 108.1-155.3) than controls (mean = 116.5 cm³, 95% CI = 105.1-127.9, p < 0.001). Thecal sac volume demonstrated excellent discrimination for SIH (area under the curve = 0.91, 95% CI = 0.83-0.98, p < 0.001). Volume > 122 cm³ was 82% sensitive and 82% specific for SIH; volume > 126 cm³ was 100% specific. Regional thoracic volume was slightly higher in patients with SIH (61.6 and 57.8 cm³, respectively, p = 0.020), and lumbar volume was notably higher (46.6 and 33.0 cm³, respectively, p < 0.001).</p><p><strong>Conclusion: </strong>Patients with SIH have a significantly larger thecal sac than controls, which can be an effective tool to diagnose these patients.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"1394-1402"},"PeriodicalIF":4.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144674551","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":"Characterization of insomnia and sleep quality in a cohort with cluster headache.","authors":"Felicia Jennysdotter Olofsgård, Caroline Ran, Stefan Spulber, Anna Steinberg, Christina Sjöstrand, Elisabet Waldenlind, Maria Lantz, Anna Sundholm, Marie Söderström, Anna Dahlgren, Andrea Carmine Belin","doi":"10.1111/head.15034","DOIUrl":"10.1111/head.15034","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The objective of this cross-sectional study was to investigate the extent of perceived sleep disturbances in a cluster headache cohort, and to compare how sleep is perceived between participants in an active headache bout to participants in a headache-free remission period.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Cluster headache is a primary headache disorder characterized by extremely painful headache attacks. These attacks commonly occur with a circadian rhythm, with a majority of patients experiencing nocturnal attacks. Sleep is affected in patients with cluster headache, but there are many uncertainties regarding the pathophysiological connection between cluster headache and sleep disturbances and to what extent sleep disturbances persist into remission.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A digital survey was sent out to 701 individuals with cluster headache between January and May 2024. The survey contained questions regarding general health, clinical cluster headache phenotype, and questions from the Karolinska Sleep Questionnaire, the Insomnia Severity Index, and the Dysfunctional Beliefs and Attitudes about Sleep-10. Scores extracted from each questionnaire were compared between study participants in an active bout versus study participants in remission, and study participants in short-term remission (&lt;5 years) versus long-term remission (≥5 years).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Of the 381 individuals who answered the survey, 325 were included in the final analysis. Participants in an active cluster headache bout reported increased sleep disturbances on all measurements compared to participants in remission (insomnia severity: adjusted odds ratio [aOR] = 1.12 [95% confidence interval (CI), 1.07-1.17] p &lt; 0.001; sleep quality: aOR = 0.67 [95% CI, 0.53-0.83] p &lt; 0.001; daytime sleepiness: aOR = 0.59 [95% CI, 0.44-0.78] p &lt; 0.001; and dysfunctional beliefs: aOR = 1.03 [95% CI, 1.01-1.04] p = 0.001). Of the participants in an active bout, 46.5% scored above the Insomnia Severity Index threshold indicating moderate to severe insomnia (≥15) and 43.7% were considered as having poor sleep quality (≤3 on the Sleep Quality Index extracted from the Karolinska Sleep Questionnaire). This is in comparison to 22.0% of participants in remission being above the moderate insomnia threshold and 22.0% considered having poor sleep quality. Participants in long-term remission had better sleep scores overall compared to participants in short-term remission (insomnia severity: aOR = 1.09 [95% CI, 1.03-1.16] p = 0.005; daytime sleepiness: aOR = 0.67 [95% CI, 0.42-1.02] p = 0.072; and dysfunctional beliefs: aOR = 1.03 [95% CI, 1.01-1.05] p = 0.006).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;Individuals with cluster headache have a large degree of sleep disturbances that are exacerbated during an active bout and not completely alleviated during remission. Future studies are needed to determine if this gradual change in sleep disturbances after an","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"1294-1307"},"PeriodicalIF":4.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12455447/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144882800","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Characterizing the patient experience during the prodrome phase of migraine: A qualitative study of symptoms and their timing.","authors":"Richard B Lipton, Jonathan Stokes, Christopher J Evans, Elizabeth Hribal, Kailee White, Katelyn Keyloun, Krutika Parikh, Pranav Gandhi, David W Dodick","doi":"10.1111/head.15024","DOIUrl":"10.1111/head.15024","url":null,"abstract":"<p><strong>Objective: </strong>This study explores and documents the patient experience during the prodrome phase of migraine.</p><p><strong>Background: </strong>Migraine attacks can be divided into four stages: the prodrome (or premonitory phase), the aura, the headache phase, and postdrome. Qualitative data on the range of symptoms during the prodrome and their timing relative to headache onset are sparse. Prodromal symptoms may predict the onset of migraine headache pain and provide a clinically useful benchmark for initiation of treatment early in an attack before pain begins.</p><p><strong>Design/methods: </strong>Eligible participants with a clinician-confirmed diagnosis of migraine and at least one prodromal symptom were consented, screened, and then participated in 60-min interviews. The interview guide included open-ended questions to elicit spontaneous reports and specific probes about prodromal symptoms based on a clinician-established list. A theory approach was used to analyze the qualitative data collected in interviews to identify key themes and gather insights; data were analyzed using ATLAS.ti.</p><p><strong>Results: </strong>Data collection for this study occurred from March 8, 2022, to May 16, 2022. Twenty interviews were conducted, and analyses demonstrated that concept saturation was achieved. Participants reported 36 unique prodromal symptoms, and each participant experienced a mean of 13 symptoms (standard deviation [SD] = 6.6) and a median of 11 symptoms (interquartile range [IQR] = 7.8-17.0) during the prodrome phase. The most commonly reported prodromal symptoms were nausea (n = 17/20, 85%), fatigue/tiredness (n = 16/20, 80%), sensitivity to light (n = 13/20, 65%), neck pain/stiffness (n = 12/20, 60%), and dizziness/vertigo/light-headedness (n = 10/20, 50%). Of the symptoms reported by at least four participants (n ≥ 4/20, 20%), neck pain/stiffness was rated most bothersome (8.9 out of 10) and sensitivity to light was rated most severe (8.5 out of 10). Almost 40% of all symptoms reported occurred less than 2 h before the start of migraine headache. Of the commonly reported symptoms, nausea (0.8h), sensitivity to light (1.0 h), and dizziness/vertigo/lightheadedness (2.0 h) began closest to headache onset; fatigue/tiredness (4.0 h) and neck pain/stiffness (4.8 h) were the most remote from headache onset.</p><p><strong>Conclusion: </strong>This study identified frequently reported prodromal symptoms, with participants commonly reporting that a migraine headache would follow their experience of prodrome within a 1- to 6-h window. Characterizing the prodrome experience may improve measurement strategies for the burden of migraine and create opportunities to treat during the prodromal phase to prevent the onset of moderate or severe headaches.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"1355-1368"},"PeriodicalIF":4.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12455446/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144951496","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The association of migraine and autistic traits effects on anxiety, depression, and headache-related disability.","authors":"Nur Nihal Türkel, Doğa Vurallı, Hayrunnisa Bolay Belen, Aslı Kuruoğlu","doi":"10.1111/head.14945","DOIUrl":"10.1111/head.14945","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;This study aimed to assess the frequency of autistic traits in patients with migraine and to examine the effect of autistic traits on migraine-related disability, as well as anxiety and depressive symptoms, through the mediating factors of anxiety sensitivity and sensory sensitivity.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Autism spectrum disorder (ASD) and migraine are two distinct clinical conditions marked by impaired sensory processing. Both conditions induce widespread alterations in the brain and exhibit symptoms associated with sensory sensitivity. Research examining the relationship between migraine and autistic traits is sparse. Moreover, the occurrence of autistic traits in patients with migraine and their effect on headache-related disability and psychiatric comorbidities has not been thoroughly investigated.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This cross-sectional study included 169 patients with migraine and 112 healthy controls. Data collection for the study was conducted from November 2022 to May 2023. The Autism Spectrum Quotient (AQ), Hospital Anxiety and Depression Scale, Anxiety Sensitivity Index, and Dunn Adolescent/Adult Sensory Profile were given to participants. The Headache Impact Test-6 and the Visual Analogue Scale were used to evaluate quality of life and headache intensity for patients with migraine. Analyses examined how autism affects migraine-related disability, anxiety, and depressive symptoms through anxiety and sensory sensitivity.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;While 35% of patients with migraine were found to have autistic traits (AQ ≥ 23), this rate was found to be 17% in healthy controls. In the migraine group, autistic traits were positively correlated with sensory sensitivity, anxiety sensitivity, and depressive symptoms. Although autistic traits did not have a direct effect on headache-related disability and anxiety symptoms, indirect effects through anxiety sensitivity and sensory sensitivity were found to be significant (total indirect effect = 0.16, 95% confidence interval [CI] = [0.08, 0.25], total indirect effect = 0.24, 95% CI = [0.14, 0.33]). In addition, autistic traits had a direct effect on depressive symptoms. Indirect effects through anxiety sensitivity and sensory sensitivity were also significant (total indirect effect = 0.14, 95% CI = [0.08, 0.21]).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This study shows that autistic traits are more frequent among patients with migraine and that these traits exhibit indirect effects on headache-related disability and psychiatric comorbidities. Recognizing autistic traits in patients with migraine may be crucial for formulating methods to mitigate comorbidities and enhance the quality of life in this population.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Plain language summary: &lt;/strong&gt;Autism and migraine are two different conditions that affect the brain and sensory traits. We do not know much about how these two conditions affect each other, so we compared autism","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"1439-1448"},"PeriodicalIF":4.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143989168","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":"Letter to the Editor regarding \"Impact of perilesional edema on severity of migraine in patients with calcified neurocysticercosis: A prospective evaluation\".","authors":"Hinpetch Daungsupawong, Viroj Wiwanitkit","doi":"10.1111/head.15036","DOIUrl":"10.1111/head.15036","url":null,"abstract":"","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"1270"},"PeriodicalIF":4.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144951601","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":"Virtual issue: Education in headache medicine: Insights and advancements from 2023 to 2024.","authors":"Alexandra Cocores, Anna Pace","doi":"10.1111/head.15005","DOIUrl":"10.1111/head.15005","url":null,"abstract":"","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"1268-1269"},"PeriodicalIF":4.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144583757","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":"Safety, tolerability, and pharmacokinetics of single and multiple ascending doses of zavegepant nasal spray in healthy adults from two phase 1 randomized, placebo-controlled trials.","authors":"Richard Bertz, Mary Donohue, Jennifer Madonia, Rajinder Bhardwaj, Kyle T Matschke, Matt S Anderson, Robert Croop, Jing Liu","doi":"10.1111/head.15042","DOIUrl":"10.1111/head.15042","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to evaluate the safety and tolerability, and characterize the pharmacokinetic profile, of zavegepant nasal spray in two phase 1 studies.</p><p><strong>Background: </strong>Zavegepant is a high-affinity, selective, small-molecule calcitonin gene-related peptide receptor antagonist, approved as a nasal spray for the acute treatment of migraine in adults.</p><p><strong>Methods: </strong>Two single-site, phase 1, placebo-controlled, randomized, double-blind studies evaluated the safety, tolerability, and pharmacokinetic profile of single ascending doses (SAD) and multiple ascending doses (MAD) of zavegepant nasal spray in healthy adults. The SAD study was conducted from October 18, 2018, to March 15, 2019, and the MAD study from September 2, 2019, to December 14, 2019. Zavegepant SAD were 0.1-20 mg single sprays and 40 mg as two 20-mg sprays. Zavegepant MAD 5-20 mg single sprays once daily (QD) and three 40-mg QD regimens given as two 20-mg sprays were evaluated.</p><p><strong>Results: </strong>In the SAD study, 72 participants were dosed in nine cohorts, and all participants completed the study. In the MAD study, 72 participants were dosed in six cohorts and 71 (99%) completed the study. In each study, zavegepant was rapidly absorbed, with a median time of maximum observed plasma concentration (T_max) of 0.54 h after a single 10 mg spray (SAD study). Exposure increased with dose, with no evidence of accumulation after repeated QD dosing. In the SAD study, 14 (26%) zavegepant-treated and three (17%) placebo-treated participants reported at least one treatment-emergent adverse events (TEAE). In the MAD study, 42 (75%) zavegepant-treated participants and 10 (63%) placebo-treated participants reported at least one TEAE. In each study, most TEAEs were mild in severity and resolved spontaneously. There was no relevant effect on electrocardiographic parameters. No signal of drug-induced liver injury was identified.</p><p><strong>Conclusions: </strong>In healthy adults, zavegepant nasal spray was safe and well tolerated at single dose up to 40 mg and in multiple doses up to 40 mg QD. Zavegepant median T_max was approximately 30 min after a single 10 mg dose nasal spray.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"1331-1343"},"PeriodicalIF":4.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12455471/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144951659","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and safety of rimegepant for the preventive treatment of migraine in Japan: A double-blind, randomized controlled trial.","authors":"Shigekazu Kitamura, Yasuhiko Matsumori, Toshimasa Yamamoto, Tomofumi Ishikawa, Yuko Hoshino, Hiroki Yoshimatsu, Alexandra Thiry, Akio Arakawa, Robert Croop, Terence Fullerton, Fumihiko Sakai, Takao Takeshima","doi":"10.1111/head.14995","DOIUrl":"10.1111/head.14995","url":null,"abstract":"<p><strong>Objectives/background: </strong>This study was undertaken to compare the efficacy of the oral calcitonin gene-related peptide receptor antagonist rimegepant relative to placebo as a preventive treatment for migraine in Japan. This was the first randomized placebo-controlled trial of rimegepant for the preventive treatment of migraine to be conducted outside the United States and the second conducted globally.</p><p><strong>Methods: </strong>In this phase 3, double-blind, randomized, multicenter trial, conducted August 9, 2022 through January 18, 2024, adults in Japan with a history of 4-18 migraine attacks/month of moderate or severe pain intensity completed a 28-day observation phase and then took rimegepant 75 mg or placebo every other day during the 12-week double-blind treatment phase. The primary endpoint was the mean change from the observation phase in the number of monthly migraine days in the last 4 weeks of the double-blind treatment phase. Safety was assessed based on the frequency of adverse events and laboratory test abnormalities during the double-blind treatment phase.</p><p><strong>Results: </strong>A total of 484 (efficacy) and 496 (safety) treated participants were evaluable. During the observation phase, participants in the rimegepant and placebo groups, respectively, reported a mean (SD) of 9.3 (3.1) and 9.0 (3.1) monthly migraine days. The study met its primary endpoint with a statistically significant difference in mean change from the observation phase in the number of monthly migraine days in the last 4 weeks of the double-blind treatment phase (difference rimegepant vs. placebo: -1.1 [95% confidence interval = -1.73 to -0.38], p = 0.002). In the rimegepant and placebo groups, respectively, 54.7% and 41.0% of participants reported adverse events and 0.8% and 0.4% reported serious adverse events during the double-blind treatment phase. No signal of drug-induced liver injury due to rimegepant was identified.</p><p><strong>Conclusion: </strong>Rimegepant 75 mg every other day demonstrated efficacy superior to that of placebo for the preventive treatment of migraine, with a favorable safety profile. NCT05399485.</p><p><strong>Plain language summary: </strong>This study tested the effectiveness of rimegepant for migraine prevention in Japan. Results showed that rimegepant was more effective than placebo in reducing monthly migraine days, with very few adverse effects. These results support the previous findings from a clinical study conducted in the United States and broaden them to a wider population.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"1403-1412"},"PeriodicalIF":4.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12455392/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144340041","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}