Trial results for a Phase 4 study (NCT05207865) evaluating the long-term safety and tolerability of rimegepant for episodic migraine prevention were posted on ClinicalTrials.gov on 2025-09-03. The study reported no serious adverse events and a low rate of study drug discontinuation.
Background
The study, titled "Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention," aimed to further evaluate the long-term safety and tolerability of daily dosing of rimegepant for the prevention of episodic migraine, including conditions like phonophobia and photophobia associated with migraine.
Trial design
The study (NCT05207865) was a Phase 4, single-arm study that enrolled 441 participants. It investigated daily dosing of rimegepant for the prevention of episodic migraine, including associated symptoms such as phonophobia and photophobia. The trial's primary objective was to assess the long-term safety and tolerability of the intervention.
Key results
The trial results focused on the safety and tolerability of daily rimegepant. Key findings include:
- The number of participants with on-treatment adverse events (AEs) with a frequency of ≥5% included counts of 33 participants, 17 participants, and 17 participants across different categories.
- No participants (0) experienced on-treatment serious adverse events (SAEs).
- 7 participants experienced AEs that led to study drug discontinuation.
- Regarding Grade 3 to 4 laboratory abnormalities on-treatment, using the Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale, no participants (0) experienced such abnormalities in most categories. One instance recorded 1 participant with a Grade 3 to 4 laboratory abnormality in one category.
What this means
The results from this Phase 4 study suggest that daily dosing of rimegepant for the prevention of episodic migraine has a favorable long-term safety and tolerability profile. The absence of serious adverse events and the low number of participants discontinuing the study due to adverse events are important findings for clinicians and patients considering this treatment option. The data supports the continued use and investigation of rimegepant in this population, particularly given the focus on real-world safety in a post-marketing setting.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05207865, titled "Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention," were posted on 2025-09-03 on clinicaltrials.gov.