Phase 3
N=1,466
Trial in Adult Subjects With Acute Migraines
Migraine, With or Without Aura
Bottom Line
View on ClinicalTrials.gov: NCT03461757 ↗Enrolled (actual)
1,466
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Percentage of Participants With Freedom From Pain at 2 Hours Post-dose — 21.2; 10.9 percentage of participants — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rimegepant (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Freedom From Pain at 2 Hours Post-dose |
21.2; 10.9 | < 0.0001 sig |
| PRIMARY Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose |
35.1; 26.8 | 0.0009 sig |
| SECONDARY Percentage of Participants With Pain Relief at 2 Hours Post-dose |
59.3; 43.3 | < 0.0001 sig |
| SECONDARY Percentage of Participants With Freedom From Functional Disability at 2 Hours Post-dose |
38.1; 25.8 | < 0.0001 sig |
| SECONDARY Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose |
47.8; 27.7 | < 0.0001 sig |
| SECONDARY Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 24 Hours Post-dose |
27.1; 17.7 | < 0.0001 sig |
| SECONDARY Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose |
14.2; 29.2 | < 0.0001 sig |
| SECONDARY Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 24 Hours Post-dose |
29.6; 16.9 | < 0.0001 sig |
| SECONDARY Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose |
42.2; 25.2 | < 0.0001 sig |
| SECONDARY Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 48 Hours Post-dose |
23.2; 16.4 | 0.0018 sig |
| SECONDARY Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 48 Hours Post-dose |
26.0; 15.4 | < 0.0001 sig |
| SECONDARY Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose |
33.4; 24.5 | 0.0007 sig |
| SECONDARY Percentage of Participants With Freedom From Functional Disability at 90 Minutes Post-dose |
30.2; 21.3 | 0.0002 sig |
| SECONDARY Percentage of Participants With Pain Relief at 90 Minutes Post-dose |
49.6; 37.2 | < 0.0001 sig |
| SECONDARY Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose |
15.7; 5.6 | < 0.0001 sig |
| SECONDARY Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 90 Minutes Post-dose |
27.4; 21.5 | 0.0128 sig |
| SECONDARY Percentage of Participants With Freedom From Pain at 90 Minutes Post-dose |
15.1; 7.3 | < 0.0001 sig |
| SECONDARY Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose |
41.7; 30.2 | 0.0003 sig |
| SECONDARY Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose |
13.5; 5.4 | < 0.0001 sig |
| SECONDARY Percentage of Participants With Pain Relief at 60 Minutes Post-dose |
36.8; 31.2 | 0.0314 sig |
| SECONDARY Percentage of Participants With Freedom From Functional Disability at 60 Minutes Post-dose |
22.3; 15.8 | 0.0025 sig |
| SECONDARY Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose |
51.0; 45.2 | 0.0898 |
| SECONDARY Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose |
36.6; 50.0 | — |
Summary
The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant ODT) versus placebo in subjects with Acute Migraines.
Eligibility Criteria
Key Inclusion Criteria
- Subject has at least 1 year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition, Beta version [1] including the following:
- 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
- Not more than 8 attacks of moderate to severe intensity per month within the last 3 months
- Consistent migraine headaches of at least 2 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening period
- Less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period.
- Subjects on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to screening visit and the dose is not expected to change during the course of the study.
- Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria.
Key Exclusion Criteria
- Subject with a history of HIV disease
- Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. subjects with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening
- Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to being enrolled)
- Subject has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (e.g., schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion might interfere with study assessments.
- Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease that causes malabsorption
- The subject has a history of current or evidence of any significant and/ or unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial.
- History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or subjects who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening visit.
- Subjects are excluded if they have previously participated in any BHV-30000 (rimegepant) study within the last 2 years.
- Participation in any other investigational clinical trial while participating in this clinical trial
Data sourced from ClinicalTrials.gov (NCT03461757). 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.