Trial reportThe journal of headache and pain2025
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.
Trial report in The journal of headache and pain, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05207865 (A Phase 4, Open-label Study to Evaluate the Safety and Tolerability of Daily Dosing of Rimegepant in Episodic Migraine Prevention), which is not on this map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 4, Open-label Study to Evaluate the Safety and Tolerability of Daily Dosing of Rimegepant in Episodic Migraine Prevention
Who cites it
2 citing papers in PubMed.
- 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.The journal of headache and pain · 2025Trial
- Short-term prevention of perimenstrual migraine with rimegepant.The journal of headache and pain · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRimegepant 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.
methodsAdults 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.
resultsOverall, 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.
conclusionRimegepant 75 mg QD for up to 24 weeks had a favorable safety profile for preventive treatment of EM.
trial registrationClinicalTrials.gov NCT05207865 (registered January 12, 2022).
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.