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Efficacy and Safety of Rimegepant in Patients with Migraine Receiving CGRP mAb Preventive Treatment | Synergy Research Center San Diego

Case Study:

Our research site embarked on a pioneering clinical trial to explore the safety, tolerability, and efficacy of oral rimegepant for acute migraine treatment among patients concurrently receiving calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) for preventive treatment. This study aimed to fill a crucial gap in migraine management by assessing the compatibility and effectiveness of combining acute and preventive therapies targeting CGRP pathways.

Objectives

  • To evaluate the safety and tolerability of rimegepant in patients undergoing CGRP mAb preventive treatment.
  • To assess the incidence, type, and severity of adverse events (AEs) in the cohort.
  • To explore the potential for additional therapeutic benefits from the combination therapy.

Methodology

This long-term, open-label safety study included 13 patients receiving one of three CGRP mAbs (erenumab, fremanezumab, or galcanezumab) for migraine prevention. The focus was on monitoring the effects of introducing rimegepant as an acute treatment option within this regimen. Safety and tolerability were the primary endpoints, evaluated through patient-reported outcomes, liver function tests, and monitoring of adverse events.

Findings

  • Treatment-Related Adverse Events: Only 3 patients (23%) experienced AEs considered potentially related to the treatment. These included viral gastroenteritis, first-degree atrioventricular block, and dizziness, all of which resolved without altering the rimegepant dosage.
  • Liver Function Tests: Among the 12 patients with available liver function data, only one exhibited an AST level slightly above normal, with no significant hepatotoxicity observed.
  • No Serious Adverse Events: The study recorded no serious AEs or AEs leading to discontinuation of the study drug, indicating a favorable safety profile for the combination therapy.

Discussion

The research highlighted the compatibility of rimegepant with ongoing CGRP mAb treatments, showing no significant safety concerns or increase in adverse events. This finding is particularly relevant, given the pharmacokinetic properties of the medications involved and their potential for interaction. Theoretical models suggest that despite preventive treatment with CGRP mAbs, significant levels of circulating CGRP remain, providing a rationale for the additional acute treatment with rimegepant.

Impact

This study underscores our research site’s capability to conduct critical clinical trials that address unmet needs in migraine treatment. It demonstrates our commitment to exploring innovative therapeutic combinations and our proficiency in navigating the complexities of clinical research. The findings contribute valuable insights into migraine management, supporting the safety of combining acute and preventive CGRP-targeted therapies.

Conclusion

The successful execution of this trial at our research site not only advances the understanding of migraine therapy but also illustrates our effectiveness and reliability in conducting clinical research. The favorable outcome encourages further investigation into combination treatments for migraine, promising improved quality of life for those affected by this debilitating condition.

Future Directions

Encouraged by these results, we advocate for larger-scale studies to confirm and extend our findings. Our research site is poised to lead further investigations, exploring optimal treatment regimens and identifying patient subsets that might benefit most from combination therapy. This case study exemplifies our contribution to migraine research and our ongoing commitment to enhancing patient care through clinical excellence.