Trial results for rimegepant (Nurtec ODT) in the acute treatment of migraine in Japanese subjects were posted on ClinicalTrials.gov on 2025-02-10. The Phase 3 study demonstrated that rimegepant 75 mg led to 32.4% of participants achieving pain freedom at 2 hours post-dose, a significant improvement compared to the 13.0% observed with placebo.

Background

Rimegepant is an investigational drug in Japan for the acute treatment of migraine. Migraine is a debilitating neurological condition characterized by severe headaches, often accompanied by other symptoms such as nausea, vomiting, and sensitivity to light and sound. Acute treatments aim to stop a migraine attack once it has started.

Trial design

This completed Phase 3 study (NCT05399459) enrolled 897 participants in Japan to evaluate the efficacy, safety, and tolerability of rimegepant for the acute treatment of migraine. Participants were randomized to receive either rimegepant 25 mg, rimegepant 75 mg, or placebo.

Key results

Key efficacy outcomes were measured at 2 hours post-dose:

What this means

The results indicate that both rimegepant 25 mg and rimegepant 75 mg doses demonstrated a numerical improvement over placebo across several key efficacy endpoints for the acute treatment of migraine in Japanese subjects. Specifically, the 75 mg dose showed higher percentages of participants achieving pain freedom, pain relief, freedom from most bothersome symptom, and ability to function normally at 2 hours post-dose compared to both the 25 mg dose and placebo. These findings suggest the potential of rimegepant as an acute treatment option for migraine in this population.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05399459, titled "Efficacy and Safety Study of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects (Japan Only)," were posted on 2025-02-10 on clinicaltrials.gov.