Time Course of Rimegepant Effect for Acute Treatment of Migraine in Adults Unsuitable for Triptans: Exploratory Endpoints from a Phase 4, Randomized, Double-Blind, Placebo-Controlled Study.

Authors

Michel Lanteri-Minet, Timothy Smith, Catherine Nalpas, Luz M Ramirez, Alexandra Thiry, Shannin McCollum, Sara Ramaker, Robert Fountaine

Published in

Neurology and therapy. Oct 03, 2026. Epub Oct 03, 2026.

Abstract

A recent placebo-controlled trial (NCT05509400) demonstrated efficacy of single-dose rimegepant 75 mg for acute treatment of migraine in adults unsuitable for triptans. However, the full time course of rimegepant effect has not been reported for this study population.
Pre-specified exploratory endpoints from study NCT05509400 assessed the percentage of participants with migraine pain relief, migraine pain freedom, return to normal function, and most bothersome symptom (MBS; nausea, photophobia, or phonophobia) freedom from 15 min to 48 h post-dose. Treatment comparisons used crude risk estimation with nominal p values.
Participants (rimegepant n = 286; placebo n = 284) were mostly female (89.3%) and had documented failure to ≥ 2 triptans with ≥ 1 reason due to prior intolerance (30.5%) or lack of efficacy (84.9%); 9.1% had a contraindication. Improvements of ≥ 5% for rimegepant over placebo with p ≤ 0.05 [difference (95% CI)] were first observed at 1 h for pain relief [8.6% (1.3%, 15.8%); p = 0.0201], 1.5 h for pain freedom [6.2% (1.5%, 11.0%); p = 0.0103] and return to normal function [7.1% (1.1%, 13.1%); p = 0.0210], and 2 h for MBS freedom [12.5% (5.4%, 19.5%); p = 0.0005]. Improvements of ≥ 5% over placebo were observed at all subsequent time points. Differences (95% CI) at 48 h were 31.2% (23.5%, 39.0%; p < 0.0001) for pain relief, 33.4% (25.9%, 40.9%; p < 0.0001) for pain freedom, 34.1% (25.8%, 42.5%; p < 0.0001) for return to normal function, and 23.2% (15.5%, 31.0%; p < 0.0001) for MBS freedom.
In some patients unsuitable for triptans, rimegepant can provide rapid onset (within 1-2 h) of migraine symptom improvement. Improvements may be observed up to 48 h. Rimegepant may be appropriate when triptans are not suitable, particularly in individuals who failed triptans previously due to lack of efficacy. Graphical abstract available for this article.
ClinicalTrials.gov: NCT05509400.

PMID:
42828704
Bibliographic data and abstract were imported from PubMed on 04 Oct 2026.

Read full publication at:
Please sign in to see all details.

Stats

1-terrible, 9-excellent. How would you rate this publication? Sign in in to submit your rating.

Post a comment

You need to be signed in to post comments. You can sign in here.

Comments

There are no comments yet.