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Trial in Adult Subjects With Acute Migraines
Phase 3 trial testing Rimegepant in Migraine, With or Without Aura in 1,811 participants. Completed in 15 October 2018.
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 1,811 |
| Start date | 27 February 2018 |
| Primary completion | 8 October 2018 |
| Estimated completion | 15 October 2018 |
| Sites | 69 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 ODT | 21.2 | 18.1 – 24.3 |
| Placebo | 10.9 | 8.5 – 13.2 |
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 ODT | 35.1 | 31.5 – 38.7 |
| Placebo | 26.8 | 23.5 – 30.2 |
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 ODT | 59.3 | 55.6 – 63.1 |
| Placebo | 43.3 | 39.5 – 47.0 |
Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Freedom from functional disability was defined as normal function.
| Group | Value | 95% CI |
|---|---|---|
| Rimegepant 75 mg ODT | 38.1 | 34.4 – 41.8 |
| Placebo | 25.8 | 22.5 – 29.1 |
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 ODT | 47.8 | 44.0 – 51.6 |
| Placebo | 27.7 | 24.4 – 31.1 |
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. Sustained freedom was defined as MBS reported at onset that was absent 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 ODT | 27.1 | 23.7 – 30.4 |
| Placebo | 17.7 | 14.9 – 20.6 |
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 ODT | 14.2 | 11.6 – 16.8 |
| Placebo | 29.2 | 25.8 – 32.6 |
Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Sustained freedom from functional disability was defined as normal function 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 ODT | 29.6 | 26.1 – 33.1 |
| Placebo | 16.9 | 14.1 – 19.7 |
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 ODT | 42.2 | 38.4 – 45.9 |
| Placebo | 25.2 | 22.0 – 28.5 |
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. Sustained freedom was defined as MBS reported at onset that was absent 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 ODT | 23.2 | 20.0 – 26.4 |
| Placebo | 16.4 | 13.6 – 19.2 |
Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Sustained freedom from functional disability was defined as normal function 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 ODT | 26.0 | 22.7 – 29.3 |
| Placebo | 15.4 | 12.7 – 18.1 |
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 ODT | 33.4 | 29.6 – 37.2 |
| Placebo | 24.5 | 21.1 – 28.0 |
The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant ODT) versus placebo in subjects with Acute Migraines.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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