The journal of headache and pain · 2025
A phase 4, 24-week, open-label study to evaluate the safety and tolerability of once-daily dosing of 75 mg rimegepant for episodic migraine prevention.
СтатьяКлиническое исследование IV фазыНазвание и аннотация: Перевод в очереди
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Antinew Jeremias, Fountaine Robert J, Loprinzo Vittorio, Straghan Esther, Dubrovin Sergey, DeBesi Patrizia, Vatakis Nick, Fullerton Terence
Аннотация
BACKGROUND: Rimegepant is a small-molecule calcitonin gene-related peptide receptor antagonist approved in adults for acute treatment of migraine (with or without aura) and preventive treatment of episodic migraine (EM). Rimegepant is well tolerated at approved doses; 75 mg as needed up to once per day for acute treatment and 75 mg every other day for preventive treatment. This study evaluated long-term safety and tolerability of once-daily (QD) rimegepant 75 mg for EM prevention.
METHODS: Adults with 4-14 migraine attacks per month received open-label oral rimegepant 75 mg QD for up to 24 weeks. Standard-of-care medications for acute treatment of migraine and stable dosing of preventive migraine medications were permitted. Endpoints included on-treatment adverse events (AEs) occurring in ≥5% of participants, on-treatment serious AEs, on-treatment AEs leading to rimegepant discontinuation, and on-treatment grade 3-4 laboratory test abnormalities. Efficacy was not assessed in this study.
RESULTS: Overall, 250 participants (female = 82.4%, White = 86.4%, mean age = 42.6 years) received ≥1 dose of rimegepant and 74.8% completed open-label treatment. Mean (SD) time on rimegepant was 19.3 (8.7) weeks. Overall, 53.6% of participants had ≥1 on-treatment AE, none had a serious AE, 1.6% had a severe AE, and 2.8% had an AE leading to rimegepant discontinuation. On-treatment AEs occurring in ≥5% of participants included nasopharyngitis (9.2%), COVID-19 (6.4%), and nausea (6.0%). On-treatment grade 3-4 laboratory test abnormalities included low lymphocytes (0.4%), high creatine kinase (3.8%), low glucose (0.4%), high low-density lipoprotein cholesterol (LDL-C; 9.8%), high fasting LDL-C (9.3%), high non-fasting LDL-C (10.2%), high potassium (1.3%), high triglycerides (0.9%), high fasting triglycerides (1.3%), and urine glucose (0.5%). No on-treatment elevations in liver transaminases (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) > 5× the upper limit of normal (ULN) or potential Hy's law cases (ALT or AST > 3× the ULN concurrent with total bilirubin levels > 2× the ULN) were observed.
CONCLUSION: Rimegepant 75 mg QD for up to 24 weeks had a favorable safety profile for preventive treatment of EM.
TRIAL REGISTRATION: ClinicalTrials.gov NCT05207865 (registered January 12, 2022).
METHODS: Adults with 4-14 migraine attacks per month received open-label oral rimegepant 75 mg QD for up to 24 weeks. Standard-of-care medications for acute treatment of migraine and stable dosing of preventive migraine medications were permitted. Endpoints included on-treatment adverse events (AEs) occurring in ≥5% of participants, on-treatment serious AEs, on-treatment AEs leading to rimegepant discontinuation, and on-treatment grade 3-4 laboratory test abnormalities. Efficacy was not assessed in this study.
RESULTS: Overall, 250 participants (female = 82.4%, White = 86.4%, mean age = 42.6 years) received ≥1 dose of rimegepant and 74.8% completed open-label treatment. Mean (SD) time on rimegepant was 19.3 (8.7) weeks. Overall, 53.6% of participants had ≥1 on-treatment AE, none had a serious AE, 1.6% had a severe AE, and 2.8% had an AE leading to rimegepant discontinuation. On-treatment AEs occurring in ≥5% of participants included nasopharyngitis (9.2%), COVID-19 (6.4%), and nausea (6.0%). On-treatment grade 3-4 laboratory test abnormalities included low lymphocytes (0.4%), high creatine kinase (3.8%), low glucose (0.4%), high low-density lipoprotein cholesterol (LDL-C; 9.8%), high fasting LDL-C (9.3%), high non-fasting LDL-C (10.2%), high potassium (1.3%), high triglycerides (0.9%), high fasting triglycerides (1.3%), and urine glucose (0.5%). No on-treatment elevations in liver transaminases (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) > 5× the upper limit of normal (ULN) or potential Hy's law cases (ALT or AST > 3× the ULN concurrent with total bilirubin levels > 2× the ULN) were observed.
CONCLUSION: Rimegepant 75 mg QD for up to 24 weeks had a favorable safety profile for preventive treatment of EM.
TRIAL REGISTRATION: ClinicalTrials.gov NCT05207865 (registered January 12, 2022).