A Phase 3 interventional study of Rimegepant and Placebo in Migraine, With or Without Aura, sponsored by Pfizer. Completed at 69 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-16.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
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Among 32 studies testing rimegepant in Migraine Disorders — 13 open to participants now, 15 under way, 6 of them phase 3. rimegepant · Migraine Disorders.
Among the 32 studies testing rimegepant in Migraine Disorders, this one is the 3rd largest by enrollment, is one of 2 that started in 2018, is one of 14 in phase 3, and was the 6th registered.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
Browse Migraine Disorders studies →13 of the 32 studies testing rimegepant in Migraine Disorders are open now, in 12 countries. Recruiting first, the newest first:
University of South Florida · Sites in United States
Ages 18+ · Healthy volunteers
Pfizer · Sites in United States, Israel
Ages 18+
Pfizer · Sites in India
Ages 18+
Pfizer · Sites in United States, Israel
Ages 18+
Medstar Health Research Institute · Sites in United States
Ages 18+
By country, each count listing its studies:
rimegepant: first FDA approval 2020 (NURTEC ODT), first EMA approval 2022. What it is approved for, and how studies give it, is on its page →
Of the 217 Migraine Disorders studies recruiting now, 66 (30%) set no upper age limit and 136 (63%) stop at 75 or younger; 44 take children under 18; 37 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
32 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 6 · Phase 3 16 · Phase 4 9
First in 2011; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,811 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Median enrollment 618 across the 32 interventional studies. Of the 17 that completed or were terminated, 15 (88%) have results posted.
This tab as a report to print or save as PDF → With an account.
24 of 32 have an industry lead sponsor. The 8 most frequent:
Pfizer is the lead sponsor of 3,337 studies on the registry; 150 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 392 (65%) have results posted.
47 studies in Migraine Disorders by Pfizer: 10 open now, 14 under way, 6 of them phase 3. Of 30 finished, 24 (80%) have results posted.
Among the 47 studies in Migraine Disorders by Pfizer, this one is the 5th largest by enrollment of the 37 interventional ones that give a count, is one of 2 that started in 2018, is one of 18 in phase 3, and was the 10th registered.
Pfizer’s Migraine Disorders studies by the year they started, since 2007.
3 of the studies testing rimegepant in Migraine Disorders that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06641466Phase 3PfizerA Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine | 2026-11-29 |
| NCT07918053Chinese PLA General HospitalA Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals | 2027-06 |
| NCT07667621University of South FloridaA Prospective, Open-Label Study Evaluating the Effectiveness of Gepants for Acute Treatment of Migraine in the Emergency Department | 2027-07 |
Add all 3 to your calendar (.ics) → With an account.
Among the 32 studies testing rimegepant in Migraine Disorders, from their registry updates:
Among Pfizer’s 47 in Migraine Disorders:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant ODT) versus placebo in subjects with Acute Migraines.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Drug: Rimegepant
Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Drug: Placebo
75 mg ODT QD
Also known as: BHV-3000
Placebo ODT to match rimegepant dose QD
Percentage of Participants With Freedom From Pain at 2 Hours Post-dose
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.
Time frame: 2 hours post-dose
Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose
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.
Time frame: 2 hours post-dose
Percentage of Participants With Pain Relief at 2 Hours Post-dose
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.
Time frame: 2 hours post-dose
Percentage of Participants With Freedom From Functional Disability at 2 Hours Post-dose
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.
Time frame: 2 hours post-dose
Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose
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.
Time frame: From 2 hours up to 24 hours post-dose
Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 24 Hours Post-dose
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.
Time frame: From 2 hours up to 24 hours post-dose
Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose
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.
Time frame: 24 hours post-dose
Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 24 Hours Post-dose
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.
Time frame: From 2 hours up to 24 hours post-dose
Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose
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.
Time frame: From 2 hours up to 48 hours post-dose
Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 48 Hours Post-dose
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.
Time frame: From 2 hours up to 48 hours post-dose
Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 48 Hours Post-dose
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.
Time frame: From 2 hours up to 48 hours post-dose
Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose
Photophobia (sensitivity to light) status was measured as absent or present in the eDiary. Freedom from photophobia was defined as photophobia absent.
Time frame: 2 hours post-dose
Percentage of Participants With Freedom From Functional Disability at 90 Minutes Post-dose
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.
Time frame: 90 minutes post-dose
Percentage of Participants With Pain Relief at 90 Minutes Post-dose
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.
Time frame: 90 minutes post-dose
Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose
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.
Time frame: From 2 hours up to 24 hours post-dose
Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 90 Minutes Post-dose
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.
Time frame: 90 minutes post dose
Percentage of Participants With Freedom From Pain at 90 Minutes Post-dose
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.
Time frame: 90 minutes post-dose
Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose
Phonophobia (sensitivity to sound) status was measured as absent or present in the eDiary. Freedom from phonophobia was defined as phonophobia absent.
Time frame: 2 hours post-dose
Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose
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.
Time frame: From 2 hours up to 48 hours post-dose
Percentage of Participants With Pain Relief at 60 Minutes Post-dose
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.
Time frame: 60 minutes post-dose
Percentage of Participants With Freedom From Functional Disability at 60 Minutes Post-dose
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.
Time frame: 60 minutes post-dose
Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose
Nausea status was measured as absent or present in the eDiary. Freedom from nausea was defined as nausea absent.
Time frame: 2 hours post-dose
Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose
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 post-dose for the participants who were pain-free at 2 hours post-dose.
Time frame: From 2 hours up to 48 hours post-dose
The study was conducted at 69 centers in the United States.
| Milestone | Rimegepant 75 mg ODT | Placebo |
|---|---|---|
| Started | 732 | 734 |
| Treated | 682 | 693 |
| Completed | 679 | 689 |
| Not completed | 53 | 45 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Lost to follow-up | 13 | 7 |
| Withdrew: Not experienced moderate/severe migraine | 28 | 25 |
| Withdrew: Non-compliance with study treatment | 0 | 1 |
| Withdrew: Pregnancy | 2 | 0 |
| Withdrew: Protocol violation | 1 | 1 |
| Withdrew: Withdrawal by subject | 7 | 7 |
| Withdrew: Other reasons | 1 | 4 |
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.
| percentage of participants | Rimegepant 75 mg ODT | Placebo |
|---|---|---|
| Percentage of Participants With Freedom From Pain at 2 Hours Post-dose | 21.2 (18.1 to 24.3) | 10.9 (8.5 to 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.
| percentage of participants | Rimegepant 75 mg ODT | Placebo |
|---|---|---|
| Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose | 35.1 (31.5 to 38.7) | 26.8 (23.5 to 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.
| percentage of participants | Rimegepant 75 mg ODT | Placebo |
|---|---|---|
| Percentage of Participants With Pain Relief at 2 Hours Post-dose | 59.3 (55.6 to 63.1) | 43.3 (39.5 to 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.
| percentage of participants | Rimegepant 75 mg ODT | Placebo |
|---|---|---|
| Percentage of Participants With Freedom From Functional Disability at 2 Hours Post-dose | 38.1 (34.4 to 41.8) | 25.8 (22.5 to 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.
| percentage of participants | Rimegepant 75 mg ODT | Placebo |
|---|---|---|
| Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose | 47.8 (44.0 to 51.6) | 27.7 (24.4 to 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.
| percentage of participants | Rimegepant 75 mg ODT | Placebo |
|---|---|---|
| Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 24 Hours Post-dose | 27.1 (23.7 to 30.4) | 17.7 (14.9 to 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.
| percentage of participants | Rimegepant 75 mg ODT | Placebo |
|---|---|---|
| Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose | 14.2 (11.6 to 16.8) | 29.2 (25.8 to 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.
| percentage of participants | Rimegepant 75 mg ODT | Placebo |
|---|---|---|
| Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 24 Hours Post-dose | 29.6 (26.1 to 33.1) | 16.9 (14.1 to 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.
| percentage of participants | Rimegepant 75 mg ODT | Placebo |
|---|---|---|
| Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose | 42.2 (38.4 to 45.9) | 25.2 (22.0 to 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.
| percentage of participants | Rimegepant 75 mg ODT | Placebo |
|---|---|---|
| Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 48 Hours Post-dose | 23.2 (20.0 to 26.4) | 16.4 (13.6 to 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.
| percentage of participants | Rimegepant 75 mg ODT | Placebo |
|---|---|---|
| Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 48 Hours Post-dose | 26.0 (22.7 to 29.3) | 15.4 (12.7 to 18.1) |
Photophobia (sensitivity to light) status was measured as absent or present in the eDiary. Freedom from photophobia was defined as photophobia absent.
| percentage of participants | Rimegepant 75 mg ODT | Placebo |
|---|---|---|
| Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose | 33.4 (29.6 to 37.2) | 24.5 (21.1 to 28.0) |
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.
| percentage of participants | Rimegepant 75 mg ODT | Placebo |
|---|---|---|
| Percentage of Participants With Freedom From Functional Disability at 90 Minutes Post-dose | 30.2 (26.7 to 33.7) | 21.3 (18.2 to 24.3) |
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.
| percentage of participants | Rimegepant 75 mg ODT | Placebo |
|---|---|---|
| Percentage of Participants With Pain Relief at 90 Minutes Post-dose | 49.6 (45.8 to 53.4) | 37.2 (33.6 to 40.9) |
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.
| percentage of participants | Rimegepant 75 mg ODT | Placebo |
|---|---|---|
| Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose | 15.7 (12.9 to 18.4) | 5.6 (3.9 to 7.3) |
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.
| percentage of participants | Rimegepant 75 mg ODT | Placebo |
|---|---|---|
| Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 90 Minutes Post-dose | 27.4 (24.0 to 30.7) | 21.5 (18.5 to 24.6) |
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.
| percentage of participants | Rimegepant 75 mg ODT | Placebo |
|---|---|---|
| Percentage of Participants With Freedom From Pain at 90 Minutes Post-dose | 15.1 (12.4 to 17.8) | 7.3 (5.4 to 9.3) |
Phonophobia (sensitivity to sound) status was measured as absent or present in the eDiary. Freedom from phonophobia was defined as phonophobia absent.
| percentage of participants | Rimegepant 75 mg ODT | Placebo |
|---|---|---|
| Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose | 41.7 (37.2 to 46.3) | 30.2 (25.9 to 34.4) |
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.
| percentage of participants | Rimegepant 75 mg ODT | Placebo |
|---|---|---|
| Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose | 13.5 (10.9 to 16.0) | 5.4 (3.7 to 7.1) |
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.
| percentage of participants | Rimegepant 75 mg ODT | Placebo |
|---|---|---|
| Percentage of Participants With Pain Relief at 60 Minutes Post-dose | 36.8 (33.1 to 40.4) | 31.2 (27.8 to 34.7) |
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.
| percentage of participants | Rimegepant 75 mg ODT | Placebo |
|---|---|---|
| Percentage of Participants With Freedom From Functional Disability at 60 Minutes Post-dose | 22.3 (19.1 to 25.4) | 15.8 (13.1 to 18.6) |
Nausea status was measured as absent or present in the eDiary. Freedom from nausea was defined as nausea absent.
| percentage of participants | Rimegepant 75 mg ODT | Placebo |
|---|---|---|
| Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose | 51.0 (46.1 to 55.9) | 45.2 (40.5 to 49.9) |
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 post-dose for the participants who were pain-free at 2 hours post-dose.
| percentage of participants | Rimegepant 75 mg ODT | Placebo |
|---|---|---|
| Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose | 36.6 (28.7 to 44.5) | 50.0 (38.7 to 61.2) |
Collected over Serious adverse events (SAEs) were collected from informed consent up to the end of the study, and adverse events (AEs) were collected from randomization up to end of the study (up to 52 days).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rimegepant 75 mg ODT | 0/682 (0%) | 0/682 (0%) | 0/682 (0%) |
| Placebo | 0/693 (0%) | 0/693 (0%) | 0/693 (0%) |
The analysis was performed on modified intent to treat (mITT) participants, defined as those who were randomized only once, took study medication, had moderate to severe pain level at migraine onset, and who provided at least 1 post-baseline efficacy measurement (i.e., after taking study medication).
| Age, Continuous(Years) | Rimegepant 75 mg ODT | Placebo | Total |
|---|---|---|---|
| Mean | 40.287 ± 12.0792 | 40.030 ± 11.8719 | 40.157 ± 11.9713 |
| Sex: Female, Male(Participants) | Rimegepant 75 mg ODT | Placebo | Total |
|---|---|---|---|
| Female | 568 | 579 | 1147 |
| Male | 101 | 103 | 204 |
| Ethnicity (NIH/OMB)(Participants) | Rimegepant 75 mg ODT | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 116 | 135 | 251 |
| Not Hispanic or Latino | 553 | 547 | 1100 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Rimegepant 75 mg ODT | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 4 | 3 | 7 |
| Asian | 8 | 19 | 27 |
| Native Hawaiian or Other Pacific Islander | 141 | 125 | 266 |
| Black or African American | 11 | 5 | 16 |
| White | 496 | 521 | 1017 |
| More than one race | 7 | 9 | 16 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Primary Migraine Type(Participants) | Rimegepant 75 mg ODT | Placebo | Total |
|---|---|---|---|
| Migraine without Aura | 480 | 462 | 942 |
| Migraine with Aura | 189 | 220 | 409 |
| Randomization Strata, Prophylactic Migraine Medication Use(Participants) | Rimegepant 75 mg ODT | Placebo | Total |
|---|---|---|---|
| Yes | 93 | 94 | 187 |
| No | 576 | 588 | 1164 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Feb 2018 to primary completion in Oct 2018, 7 months.
Results were first posted in Mar 2020, 1 year 5 months after primary completion. A results delay was requested in Oct 2019.
Of 114 industry-sponsored phase 3 interventional studies under Migraine Disorders, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 31. This study's 7 months is below that.
Counting every sponsor, half of 140 studies reached it within 19 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rimegepant