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Safety and Efficacy Study in Adult Subjects With Acute Migraines
Phase 3 trial testing Rimegepant in Migraine, With or Without Aura in 1,485 participants. Completed in 26 January 2018.
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 1,485 |
| Start date | 18 July 2017 |
| Primary completion | 21 January 2018 |
| Estimated completion | 26 January 2018 |
| Sites | 50 locations across United States |
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18 and older, any sex, with Migraine, With or Without Aura. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the electronic diary (eDiary). Pain freedom was defined as pain level of none.
| Group | Value | 95% CI |
|---|---|---|
| Rimegepant 75 mg | 19.2 | 15.8 – 22.5 |
| Placebo | 14.2 | 11.3 – 17.2 |
MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at onset that was absent post-dose.
| Group | Value | 95% CI |
|---|---|---|
| Rimegepant 75 mg | 36.6 | 32.6 – 40.7 |
| Placebo | 27.7 | 24.0 – 31.5 |
Photophobia (sensitivity to light) status was measured as absent or present in the eDiary. Freedom from photophobia was defined as photophobia absent.
| Group | Value | 95% CI |
|---|---|---|
| Rimegepant 75 mg | 34.9 | 30.6 – 39.2 |
| Placebo | 24.8 | 20.9 – 28.6 |
Phonophobia (sensitivity to sound) status was measured as absent or present in the eDiary. Freedom from phonophobia was defined as phonophobia absent.
| Group | Value | 95% CI |
|---|---|---|
| Rimegepant 75 mg | 38.6 | 33.4 – 43.7 |
| Placebo | 30.9 | 26.2 – 35.5 |
Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relief was defined as pain level of none or mild.
| Group | Value | 95% CI |
|---|---|---|
| Rimegepant 75 mg | 56.0 | 51.8 – 60.2 |
| Placebo | 45.7 | 41.5 – 49.9 |
Nausea status was measured as absent or present in the eDiary. Freedom from nausea was defined as nausea absent.
| Group | Value | 95% CI |
|---|---|---|
| Rimegepant 75 mg | 46.9 | 41.4 – 52.3 |
| Placebo | 41.6 | 36.2 – 47.0 |
Participants who did not experience relief of their migraine headache at the end of 2 hours after dosing with study medication (and after the 2-hour assessments had been completed on the eDiary) were permitted to use the following rescue medications: aspirin, ibuprofen, acetaminophen up to 1000 mg/day (this includes Excedrin Migraine), naproxen (or any other type of nonsteroidal anti-inflammatory drug), antiemetics (e.g., metoclopramide or promethazine), or baclofen. The participant's use of rescue medication was recorded by the participant in a paper diary.
| Group | Value | 95% CI |
|---|---|---|
| Rimegepant 75 mg | 20.4 | 17.1 – 23.8 |
| Placebo | 31.8 | 27.9 – 35.6 |
Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain freedom was defined as pain level of none at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.
| Group | Value | 95% CI |
|---|---|---|
| Rimegepant 75 mg | 14.0 | 11.1 – 16.9 |
| Placebo | 8.1 | 5.8 – 10.4 |
Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.
| Group | Value | 95% CI |
|---|---|---|
| Rimegepant 75 mg | 38.9 | 34.8 – 43.0 |
| Placebo | 27.9 | 24.2 – 31.7 |
Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain freedom was defined as pain level of none at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.
| Group | Value | 95% CI |
|---|---|---|
| Rimegepant 75 mg | 11.6 | 8.9 – 14.3 |
| Placebo | 7.2 | 5.0 – 9.4 |
Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.
| Group | Value | 95% CI |
|---|---|---|
| Rimegepant 75 mg | 33.7 | 29.7 – 37.7 |
| Placebo | 23.9 | 20.3 – 27.4 |
Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relapse was defined as pain level of mild, moderate, or severe after 2 hours up to 48 hours for the participants who were pain-free at 2 hours post-dose.
| Group | Value | 95% CI |
|---|---|---|
| Rimegepant 75 mg | 40.1 | 30.6 – 49.6 |
| Placebo | 50.0 | 39.0 – 61.0 |
Time frame: Serious adverse events (SAEs) were collected from informed consent up to the end of study, and adverse events (AEs) were collected from randomization up to the end of the study (up to 52 days).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Rimegepant 75 mg | Placebo |
|---|---|---|---|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | — | — |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | — | — |
| Colitis | Gastrointestinal disorders | — | — |
Most-reported serious reactions: Acute Respiratory Failure, Pulmonary Embolism, Colitis.
Data from ClinicalTrials.gov NCT03235479 adverse events section.
The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant) versus placebo in subjects with Acute Migraines
8 peer-reviewed publications reference this trial (live from Europe PMC):
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