{"title":"拉科沙胺对慢性偏头痛患者的影响：一项随机、双盲临床试验","authors":"Mobina Mirhosseini, Hamed Cheraghmakani, Monireh Ghazaeian, Abolfazl Hosseinnataj","doi":"10.1155/ijcp/2431261","DOIUrl":null,"url":null,"abstract":"<p><b>Purpose:</b> Calcitonin gene-related peptide (CGRP) is a key peptide released during trigeminal system-initiated migraine attacks. Evidence suggests that lacosamide can inhibit CGRP release. This study aimed to assess the effectiveness of lacosamide in patients with chronic migraine.</p><p><b>Methods:</b> This double-blind, randomized clinical study involved 83 chronic migraine patients, who were assigned to either a lacosamide group or a placebo group. The intervention group received 50 mg of lacosamide twice daily, with a weekly increase to a maximum tolerated dose of 200 mg twice daily, along with topiramate 25 mg twice daily. The placebo group received a placebo along with topiramate for 12 weeks. Headache frequency and severity were assessed using the NRS and VAS. Disability was evaluated with the MIDAS questionnaire at baseline and after 3 months.</p><p><b>Results:</b> Of the 83 patients enrolled in the study, 66 completed it and were analyzed. The intervention group exhibited a significant reduction in headache severity, as measured by VAS and headache frequency (<i>p</i>: 0.001). Outdoor and indoor activity performance and headache-free and analgesic-free days significantly improved in the intervention group compared to the control group during the study period (<i>p</i>: < 0.01). Most patients in the intervention group exhibited lower MIDAS disability scores, although the difference was not statistically significant between two groups (<i>p</i>: 0.291).</p><p><b>Conclusion:</b> In conclusion, our findings suggest that lacosamide could be effective in reducing the frequency and severity of headaches in people with chronic migraines. Additionally, the tolerability of this treatment regimen for migraine prevention was satisfactory, with no significant side effects.</p><p><b>Trial Registration:</b> Iranian Registry of Clinical Trials: IRCT20190804044429N9</p>","PeriodicalId":13782,"journal":{"name":"International Journal of Clinical Practice","volume":"2025 1","pages":""},"PeriodicalIF":2.4000,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1155/ijcp/2431261","citationCount":"0","resultStr":"{\"title\":\"The Effects of Lacosamide on Patients With Chronic Migraine: A Randomized, Double-Blind, Clinical Trial\",\"authors\":\"Mobina Mirhosseini, Hamed Cheraghmakani, Monireh Ghazaeian, Abolfazl Hosseinnataj\",\"doi\":\"10.1155/ijcp/2431261\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><b>Purpose:</b> Calcitonin gene-related peptide (CGRP) is a key peptide released during trigeminal system-initiated migraine attacks. Evidence suggests that lacosamide can inhibit CGRP release. This study aimed to assess the effectiveness of lacosamide in patients with chronic migraine.</p><p><b>Methods:</b> This double-blind, randomized clinical study involved 83 chronic migraine patients, who were assigned to either a lacosamide group or a placebo group. The intervention group received 50 mg of lacosamide twice daily, with a weekly increase to a maximum tolerated dose of 200 mg twice daily, along with topiramate 25 mg twice daily. The placebo group received a placebo along with topiramate for 12 weeks. Headache frequency and severity were assessed using the NRS and VAS. Disability was evaluated with the MIDAS questionnaire at baseline and after 3 months.</p><p><b>Results:</b> Of the 83 patients enrolled in the study, 66 completed it and were analyzed. The intervention group exhibited a significant reduction in headache severity, as measured by VAS and headache frequency (<i>p</i>: 0.001). Outdoor and indoor activity performance and headache-free and analgesic-free days significantly improved in the intervention group compared to the control group during the study period (<i>p</i>: < 0.01). Most patients in the intervention group exhibited lower MIDAS disability scores, although the difference was not statistically significant between two groups (<i>p</i>: 0.291).</p><p><b>Conclusion:</b> In conclusion, our findings suggest that lacosamide could be effective in reducing the frequency and severity of headaches in people with chronic migraines. Additionally, the tolerability of this treatment regimen for migraine prevention was satisfactory, with no significant side effects.</p><p><b>Trial Registration:</b> Iranian Registry of Clinical Trials: IRCT20190804044429N9</p>\",\"PeriodicalId\":13782,\"journal\":{\"name\":\"International Journal of Clinical Practice\",\"volume\":\"2025 1\",\"pages\":\"\"},\"PeriodicalIF\":2.4000,\"publicationDate\":\"2025-08-27\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1155/ijcp/2431261\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Clinical Practice\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1155/ijcp/2431261\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Clinical Practice","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1155/ijcp/2431261","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
The Effects of Lacosamide on Patients With Chronic Migraine: A Randomized, Double-Blind, Clinical Trial
Purpose: Calcitonin gene-related peptide (CGRP) is a key peptide released during trigeminal system-initiated migraine attacks. Evidence suggests that lacosamide can inhibit CGRP release. This study aimed to assess the effectiveness of lacosamide in patients with chronic migraine.
Methods: This double-blind, randomized clinical study involved 83 chronic migraine patients, who were assigned to either a lacosamide group or a placebo group. The intervention group received 50 mg of lacosamide twice daily, with a weekly increase to a maximum tolerated dose of 200 mg twice daily, along with topiramate 25 mg twice daily. The placebo group received a placebo along with topiramate for 12 weeks. Headache frequency and severity were assessed using the NRS and VAS. Disability was evaluated with the MIDAS questionnaire at baseline and after 3 months.
Results: Of the 83 patients enrolled in the study, 66 completed it and were analyzed. The intervention group exhibited a significant reduction in headache severity, as measured by VAS and headache frequency (p: 0.001). Outdoor and indoor activity performance and headache-free and analgesic-free days significantly improved in the intervention group compared to the control group during the study period (p: < 0.01). Most patients in the intervention group exhibited lower MIDAS disability scores, although the difference was not statistically significant between two groups (p: 0.291).
Conclusion: In conclusion, our findings suggest that lacosamide could be effective in reducing the frequency and severity of headaches in people with chronic migraines. Additionally, the tolerability of this treatment regimen for migraine prevention was satisfactory, with no significant side effects.
Trial Registration: Iranian Registry of Clinical Trials: IRCT20190804044429N9
期刊介绍：
IJCP is a general medical journal. IJCP gives special priority to work that has international appeal.
IJCP publishes:
Editorials. IJCP Editorials are commissioned. [Peer reviewed at the editor''s discretion]
Perspectives. Most IJCP Perspectives are commissioned. Example. [Peer reviewed at the editor''s discretion]
Study design and interpretation. Example. [Always peer reviewed]
Original data from clinical investigations. In particular: Primary research papers from RCTs, observational studies, epidemiological studies; pre-specified sub-analyses; pooled analyses. [Always peer reviewed]
Meta-analyses. [Always peer reviewed]
Systematic reviews. From October 2009, special priority will be given to systematic reviews. [Always peer reviewed]
Non-systematic/narrative reviews. From October 2009, reviews that are not systematic will be considered only if they include a discrete Methods section that must explicitly describe the authors'' approach. Special priority will, however, be given to systematic reviews. [Always peer reviewed]
''How to…'' papers. Example. [Always peer reviewed]
Consensus statements. [Always peer reviewed] Short reports. [Always peer reviewed]
Letters. [Peer reviewed at the editor''s discretion]
International scope
IJCP publishes work from investigators globally. Around 30% of IJCP articles list an author from the UK. Around 30% of IJCP articles list an author from the USA or Canada. Around 45% of IJCP articles list an author from a European country that is not the UK. Around 15% of articles published in IJCP list an author from a country in the Asia-Pacific region.
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