Phase 4
N=658
Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of Inadequate Response to Oral Preventive Medications
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT05518123 ↗Enrolled (actual)
658
Serious AEs
0.8%
Results posted
May 2026
Primary outcome: Primary: Mean Change From Observation Phase (OP) in the Number of Migraine Days Per Month Over the Entire DBT Phase (Weeks 1 to 12) — -2.1; -0.5 Migraine Days per month — 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 Mean Change From Observation Phase (OP) in the Number of Migraine Days Per Month Over the Entire DBT Phase (Weeks 1 to 12) |
-2.1; -0.5 | <0.0001 sig |
| SECONDARY Percentage of Participants With >= 50 Percent (%) Reduction From OP in the Number of Moderate or Severe Migraine Days (MD) Per Month Over the Entire DBT Phase (Weeks 1 to 12) |
34.0; 13.8 | <0.0001 sig |
| SECONDARY Mean Change From OP in the Number of Migraine Days Per Month in the First 4 Weeks (Weeks 1 to 4) of the DBT Phase |
-1.8; -0.1 | <0.0001 sig |
| SECONDARY Mean Change From OP in the Number of Migraine Days Per Month in the Last 4 Weeks (Weeks 9 to 12) of the DBT Phase |
-2.3; -0.9 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in the Migraine-Specific Quality-of-Life Questionnaire (MSQ) Version 2.1 Restrictive Role Function Domain Score at Week 12 of the DBT Phase |
21.1; 14.6 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in the Migraine Interictal Burden Scale (MIBS) Score at Week 12 of the DBT Phase |
-1.9; -1.0 | =0.0006 sig |
| SECONDARY Number of Participants With Any Adverse Events (AEs) by Worst Intensity in the DBT Phase. |
186; 178; 132; 126; 77; 65 | — |
| SECONDARY Number of Participants With Any AEs by Worst Intensity in the OLE Phase |
121; 106; 76; 71; 52; 52 | — |
| SECONDARY Number of Participants With Serious AEs (SAEs) in the DBT Phase |
1; 5 | — |
| SECONDARY Number of Participants With SAEs in the OLE Phase |
2; 4 | — |
| SECONDARY Number of Participants With AEs Leading to Study Drug Discontinuation in the DBT Phase |
6; 3 | — |
| SECONDARY Number of Participants With AEs Leading to Study Drug Discontinuation in the OLE Phase |
3; 3 | — |
| SECONDARY Number of Participants With Grade 3 to 4 Laboratory Abnormalities: DBT Phase |
1; 0; 1; 0 | — |
| SECONDARY Number of Participants With Grade 3 to 4 Laboratory Abnormalities: OLE Phase |
0; 1; 0; 1; 0; 1 | — |
| SECONDARY Percentage of Participants With >= 50% Reduction From OP in the Number of Migraine Days Per Month (Regardless of Pain Intensity) Over the Entire DBT Phase (Weeks 1 to 12) |
27.5; 9.4 | — |
| SECONDARY Mean Number of Acute Migraine-Specific Medication Days Per Month in Each Month and Over the Entire DBT Phase (Weeks 1 to 12) |
3.3; 4.6; 3.4; 4.8; 3.5; 4.4 | — |
| SECONDARY Mean Change From Baseline in MIBS Scores at Weeks 4, 8, and 12 in the DBT Phase |
-1.3; -0.7; -1.7; -1.1; -1.9; -1.0 | — |
| SECONDARY Mean Change From Baseline in MSQ Domain Scores at Weeks 4, 8, and 12 in the DBT Phase |
18.2; 12.7; 20.7; 13.8; 21.1; 14.6 | — |
| SECONDARY Mean Change From Baseline in Migraine Functional Impact Questionnaire (MFIQ) Domain Scores in Each Month of the DBT Phase |
-15.5; -8.8; -18.0; -11.3; -17.4; -11.7 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI) - Migraine Absenteeism Scores at Weeks 4, 8, and 12 in the DBT Phase |
-3.4; -2.0; -4.1; -2.0; -3.0; -1.4 | — |
| SECONDARY Change From Baseline in WPAI - Migraine Presenteeism Scores at Weeks 4, 8, and 12 in the DBT Phase |
-16.8; -11.8; -19.8; -11.8; -18.8; -10.9 | — |
| SECONDARY Change From Baseline in WPAI - Migraine Work Productivity Loss Scores at Weeks 4, 8, and 12 in the DBT Phase |
-17.4; -11.9; -20.8; -11.9; -19.1; -11.5 | — |
| SECONDARY Change From Baseline in WPAI - Migraine Activity Impairment Scores at Weeks 4, 8, and 12 in the DBT Phase |
-18.5; -14.4; -23.0; -15.7; -21.6; -14.0 | — |
| SECONDARY Mean Change From Baseline in Patient Global Assessment (PGA) Score in Each Month of the DBT Phase |
-0.1; 0.0; -0.2; 0.0; -0.2; 0.0 | — |
Summary
This study is being conducted to evaluate the efficacy and tolerability of rimegepant for migraine prophylaxis in adults with a history of inadequate response to oral preventive medications
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 than15 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. Prior inadequate response, within 10 years of the Screening Visit, to agents across 2-4 categories of recognized, orally-administered, migraine-preventive medications where at least one example of prior inadequate response is due to lack of efficacy or prior intolerance (not contraindication).
Exclusion Criteria
- History of cluster headaches, basilar migraine (migraine with brainstem aura), or hemiplegic migraine.
- Current medication overuse headaches.
- 15 or more headache days (migraine or non-migraine) per month in any of the 3-months prior to the Screening Visit or during the first 28- days of the Observation Phase.
- Inadequate response (due to lack of efficacy, prior intolerance, or contraindication) to agents across > 4 categories of recognized, orally administered, migraine-preventive medications.
- 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 (NCT05518123). 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.