Trial results for a Phase 4 study investigating rimegepant (Nurtec ODT) for episodic migraine prevention were posted on ClinicalTrials.gov on 2025-12-16. The study showed that rimegepant significantly reduced the mean number of migraine days per month by 4.0 days compared to 2.2 days for placebo, a statistically significant difference of 1.8 days (p=0.0001).
Background
The study, titled "Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens," aimed to compare the efficacy and safety of daily and every other day dosing of rimegepant to placebo as a preventive treatment for episodic migraine.
Trial design
The study (NCT05217927) was a Phase 4, randomized, placebo-controlled trial that enrolled 1415 participants. The study investigated rimegepant 75mg daily dosing and rimegepant 75mg every other day dosing compared to placebo comparator dosing for the prevention of migraine.
Key results
The trial results demonstrated significant reductions in migraine days for participants receiving rimegepant compared to placebo over the 12-week double-blind treatment phase.
- For the "Mean Change From Observation Phase (OP) in the Number of Migraine Days Per Month Over Entire DBT Phase (Weeks 1 to 12)":
The DB Rimegepant group experienced a mean reduction of -4.0 Days per month, compared to -2.2 Days per month for the DB Placebo group. A Mixed Models Analysis indicated a Least Square Mean (LSM) Difference of -1.8 (97.5% Confidence Interval: -2.35 to -1.19) with a p-value of 0.0001, favoring rimegepant.
- For the "Percentage of Participants With Greater Than Equal to (>=) 50 Percent (%) Reduction From OP in Number of Moderate to Severe Migraine Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)":
58.1 Percentage of participants in the DB Rimegepant group achieved this reduction, versus 33.3 Percentage of participants in the DB Placebo group. A Mantel Haenszel analysis showed a difference in percentage of 24.7 (97.5% Confidence Interval: 14.6 to 34.8) with a p-value of 0.0001, favoring rimegepant.
Similar significant reductions were observed in the last 4 weeks (Weeks 9 to 12) of the DBT phase. The DB Rimegepant group showed a mean change of -4.2 Days per month compared to -2.8 Days per month for DB Placebo, with an LSM Difference of -1.4 (97.5% Confidence Interval: -2.12 to -0.71) and a p-value of 0.0001.
What this means
The results from this Phase 4 trial suggest that rimegepant is an effective preventive treatment for episodic migraine, demonstrating a statistically significant reduction in migraine days and a higher proportion of responders compared to placebo. These findings support the use of rimegepant in managing episodic migraine and provide valuable data for clinicians and patients considering preventive treatment options.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05217927, titled "Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens," were posted on 2025-12-16 on clinicaltrials.gov.