Trial results for a long-term safety study of Rimegepant 75mg ODT for the acute treatment of migraine in Chinese participants were posted on ClinicalTrials.gov on 2025-02-20. The study reported that 203 participants experienced treatment-emergent adverse events during the treatment safety period.
Background
Rimegepant (Nurtec ODT) is an orally disintegrating tablet used for the acute treatment of migraine. This study specifically focused on its long-term safety and tolerability in Chinese participants.
Trial design
This completed Phase 3 trial (NCT05371652) enrolled 241 participants to evaluate the long-term safety and tolerability of Rimegepant 75mg ODT in Chinese subjects with Acute Migraine. The study was designed as a single-arm investigation into safety outcomes over an extended period.
Key results
The trial evaluated several safety outcomes during both a treatment safety period and a follow-up safety period for participants receiving Rimegepant 75 mg ODT.
- During the treatment safety period, the number of participants with treatment-emergent adverse events (TEAEs) was 203.
- During the follow-up safety period, the number of participants with TEAEs was 24.
- The number of participants with serious adverse events (SAEs) during the treatment safety period was 7.
- No participants experienced SAEs during the follow-up safety period (0 participants).
- Adverse events leading to study drug discontinuation occurred in 1 participant during the treatment safety period and in 0 participants during the follow-up safety period.
- During the treatment safety period, the number of participants with Electrocardiogram (ECG) Abnormalities was 225.
- Also during the treatment safety period, the number of participants with Electrocardiogram (ECG) Abnormalities was 6.
- Further during the treatment safety period, the number of participants with Electrocardiogram (ECG) Abnormalities was 0.
- Additionally during the treatment safety period, the number of participants with Electrocardiogram (ECG) Abnormalities was 0.
- During the follow-up safety period, the number of participants with ECG Abnormalities was 209.
- Also during the follow-up safety period, the number of participants with ECG Abnormalities was 2.
What this means
The results of this long-term Phase 3 study provide safety and tolerability data for Rimegepant 75mg ODT in Chinese participants with acute migraine. The observed rates of treatment-emergent adverse events (203 participants) and serious adverse events (7 participants) during the treatment safety period offer insights into the drug's safety profile in this specific population. The low number of discontinuations due to adverse events (1 participant) suggests generally manageable tolerability over the study duration. The detailed reporting of ECG abnormalities further contributes to the comprehensive safety assessment of Rimegepant.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05371652, titled "A Study to Learn About the Long-term Safety of Rimegepant for the Acute Treatment of Migraine in Chinese Participants," were posted on 2025-02-20 on clinicaltrials.gov.