Phase 4
N=633
Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT05509400 ↗Enrolled (actual)
633
Serious AEs
0.2%
Results posted
Apr 2026
Primary outcome: Primary: Percentage of Participants With Pain Relief at 2 Hours Post-Dose: DBT Phase — 55.9; 32.7 Percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Rimegepant (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Pain Relief at 2 Hours Post-Dose: DBT Phase |
55.9; 32.7 | <0.0001 sig |
| SECONDARY Percentage of Participants With Pain Freedom at 2 Hours Post-Dose: DBT Phase |
22.7; 7.4 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Used Rescue Medications Within 24 Hours Post-Dose: DBT Phase |
18.0; 46.2 | <0.0001 sig |
| SECONDARY Percentage of Participants With Return to Normal Function at 2 Hours Post-Dose: DBT Phase |
28.9; 12.7 | <0.0001 sig |
| SECONDARY Percentage of Participants With Sustained Return to Normal Function From 2 to 24 Hours Post-Dose: DBT Phase |
18.1; 6.8 | 0.0002 sig |
| SECONDARY Percentage of Participants With Sustained Return to Normal Function From 2 to 48 Hours Post-Dose: DBT Phase |
15.9; 4.2 | <0.0001 sig |
| SECONDARY Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-Dose: DBT Phase |
38.8; 14.4 | <0.0001 sig |
| SECONDARY Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-Dose: DBT Phase |
33.9; 10.6 | <0.0001 sig |
| SECONDARY Percentage of Participants With Sustained Freedom From Pain From 2 to 24 Hours Post-Dose: DBT Phase |
14.0; 4.9 | 0.0002 sig |
| SECONDARY Percentage of Participants With Sustained Freedom From Pain From 2 to 48 Hours Post-Dose: DBT Phase |
12.2; 2.8 | <0.0001 sig |
| SECONDARY Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-Dose: DBT Phase |
31.1; 18.7 | 0.0005 sig |
| SECONDARY Reliability of Rimegepant Effect in the OLE Phase Based on Evaluable Qualifying Migraine Attacks (EQMA) of DBT and OLE Phase |
64.2; 65.1; 66.9; 69.1; 70.8; 71.1 | — |
| SECONDARY Mean Change From Historical Baseline in Number of Migraine Days Per Month by Headache Pain Intensity at Months 1, 2 and 3 and Overall: OLE Phase |
7.8; 7.8; -3.3; -3.6; -2.3; -2.7 | — |
| SECONDARY Percentage of Participants With at Least 50% Reduction From Historical Baseline in the Number of Migraine Days Per Month by Headache Pain Intensity at Months 1, 2 and 3 and Overall: OLE Phase |
50.7; 57.9; 42.1; 43.3; 40.5; 42.2 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) by Intensity: DBT Phase |
31; 19; 6; 15; 0; 1 | — |
| SECONDARY Number of Participants With Serious AEs: DBT Phase |
0; 0 | — |
| SECONDARY Number of Participants With AEs Leading to Study Drug Discontinuation: DBT Phase |
0; 0 | — |
| SECONDARY Number of Participants With Any On-Treatment Grade 3 to 4 Laboratory Abnormalities: DBT Phase |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With AEs by Intensity: OLE Phase |
97; 86; 65; 53; 1; 2 | — |
| SECONDARY Number of Participants With Serious AEs: OLE Phase |
1; 1 | — |
| SECONDARY Number of Participants With AEs Leading to Study Drug Discontinuation: OLE Phase |
3; 2 | — |
| SECONDARY Number of Participants With On-Treatment Grade 3 to 4 Laboratory Abnormalities: OLE Phase |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Mean Change From Baseline in the Migraine Interictal Burden Scale (MIBS) Score at Weeks 4, 8, and 12: OLE Phase |
-0.8; -1.1; -1.0; -1.3; -1.1; -1.5 | — |
Summary
This study is being conducted to evaluate the efficacy and tolerability of rimegepant in a population of adults that are unsuitable for triptan medications due to a previous intolerance, lack of efficacy, or contraindication (including a history of clinically-relevant cardiovascular disease).
Eligibility Criteria
Inclusion Criteria
- Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
- Migraine attacks, on average, lasting about 4 - 72 hours if untreated.
- 4 to 14 migraine days per month on average across the 3 months prior to the Screening Visit (month is defined as 28 days for the purpose of this protocol).
- Less than 15 headache days (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and throughout the Screening Phase.
- Subjects must be able to distinguish migraine attacks from tension/cluster headaches.
- Subjects on prophylactic migraine medication (excluding CGRP antagonists) are permitted to remain on therapy if they have been on a stable dose for at least 3 months (12 weeks) prior to the Screening Visit, and if the dose is not expected to change during the course of the study.
- Triptan unsuitable
Exclusion Criteria
-Target Disease Exclusion:
- History of cluster headache, basilar migraine, or hemiplegic migraine
- Current medication overuse headaches
- Headaches occurring 15 or more days per month (migraine or non-migraine) in any of the 3 months prior to the Screening Visit
- Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome [CRPS])
- Other pain syndromes (including trigeminal neuralgia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, interfere with study assessments of safety or efficacy
Data sourced from ClinicalTrials.gov (NCT05509400). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.