ClinicalTrials.gov posted results on 3 September 2026 for a completed Phase 3 study of rimegepant to help prevent migraine in Chinese subjects. Among 787 participants, the adjusted mean reduction in monthly migraine days over 12 weeks was greater with rimegepant than placebo.

Background

The study evaluated rimegepant, also listed as rimegepant sulfate and Nurtec ODT, for migraine prevention. Its stated purpose was to assess the drug’s safety and effects in Chinese adults with migraine. The registry listed rimegepant and placebo as the interventions.

Trial design

This was a completed Phase 3 trial identified as NCT05810038, with 787 participants enrolled and migraine as the listed condition. Participants were randomly assigned to treatment groups and entered a 12-week double-blind treatment phase within a study lasting around 30 weeks and including four phases and 11 visits.

The registry reported measurements for monthly migraine days, the proportion of participants achieving at least a 50% reduction in moderate-to-severe migraine days, migraine-specific quality of life, and acute migraine medication use. No primary outcome entries were supplied in the data block.

Key results

Over the full 12-week double-blind treatment phase, the least-squares mean change in monthly migraine days was -3.64 migraine days per month with rimegepant, compared with -2.63 migraine days per month with placebo; the standard error was 0.14 in each group. The mixed-model difference was -1.02 migraine days, with a 95% confidence interval of -1.40 to -0.63 and p=0.0001.

  • 55.0% of participants receiving rimegepant and 38.4% receiving placebo achieved at least a 50% reduction in moderate-to-severe migraine days. The between-group difference was 16.6 percentage points, with a 95% confidence interval of 9.65 to 23.49 and p=0.0001.
  • During weeks 1 to 4, monthly migraine days changed by -2.92 with rimegepant versus -1.92 with placebo. The difference was -1.0, with a 95% confidence interval of -1.45 to -0.55 and p=0.0001.
  • During weeks 9 to 12, the corresponding changes were -4.19 and -3.11; the difference was -1.08, with a 95% confidence interval of -1.54 to -0.62 and p=0.0001.
  • At week 12, the MSQoL role function-restrictive score increased by 14.2 points with rimegepant versus 9.9 points with placebo. Acute migraine medication use averaged 2.29 days per month versus 3.18 days per month.

What this means

The posted results show greater reductions in monthly migraine days and acute medication-use days with rimegepant than with placebo in this completed Chinese Phase 3 study. The reported quality-of-life score also improved more in the rimegepant group, while the registry supplied no adverse-event summary in the data block.

The results support a comparative benefit signal for migraine prevention in the studied population. They do not, by themselves, establish safety conclusions beyond the absence of a supplied adverse-event summary or indicate a change to an approved use.

Source

Source: ClinicalTrials.gov, registry results for “A Study to Learn About the Safety and Effects of Rimegepant to Prevent Migraine in Chinese Subjects,” NCT05810038, posted 3 September 2026. The record is available at clinicaltrials.gov/study/NCT05810038.