Trial · NCT03461757
Trial in Adult Subjects With Acute Migraines
NCT03461757, Phase 3, Completed, Pfizer; results first posted 2020-03-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial in Adult Subjects With Acute Migraines. Trials, record NCT03461757. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03461757
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial in Adult Subjects With Acute Migraines
- NCT number
- NCT03461757
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,811 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Migraine, With or Without Aura
- Interventions
- Rimegepant, Placebo
- First posted
- 2018-03-12
- Last updated
- 2023-02-16
- Results first posted
- 2020-03-27
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Freedom From Pain at 2 Hours Post-dose | 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. |
| Primary | Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose | 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. |
| Secondary | Percentage of Participants With Pain Relief at 2 Hours Post-dose | 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. |
| Secondary | Percentage of Participants With Freedom From Functional Disability at 2 Hours Post-dose | 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. |
| Secondary | Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose | From 2 hours up 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. |
| Secondary | Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 24 Hours Post-dose | From 2 hours up 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. |
| Secondary | Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose | 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. |
| Secondary | Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 24 Hours Post-dose | From 2 hours up 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. |
| Secondary | Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose | From 2 hours up 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. |
| Secondary | Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 48 Hours Post-dose | From 2 hours up 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. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Freedom From Pain at 2 Hours Post-dose | 2 hours post-dose | The analysis was performed on modified intent to treat (mITT) participants. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose | 2 hours post-dose | The analysis was performed on mITT participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Pain Relief at 2 Hours Post-dose | 2 hours post-dose | The analysis was performed on mITT participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Freedom From Functional Disability at 2 Hours Post-dose | 2 hours post-dose | The analysis was performed on mITT participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose | From 2 hours up to 24 hours post-dose | The analysis was performed on mITT participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 24 Hours Post-dose | From 2 hours up to 24 hours post-dose | The analysis was performed on mITT participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose | 24 hours post-dose | The analysis was performed on mITT participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 24 Hours Post-dose | From 2 hours up to 24 hours post-dose | The analysis was performed on mITT participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose | From 2 hours up to 48 hours post-dose | The analysis was performed on mITT participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 48 Hours Post-dose | From 2 hours up to 48 hours post-dose | The analysis was performed on mITT participants. | percentage of participants | NUMBER |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Freedom From Pain at 2 Hours Post-dose | Rimegepant 75 mg ODT | 21.2 | 95% Confidence Interval 18.1 to 24.3 | percentage of participants | |
| Percentage of Participants With Freedom From Pain at 2 Hours Post-dose | Placebo | 10.9 | 95% Confidence Interval 8.5 to 13.2 | percentage of participants | |
| Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose | Rimegepant 75 mg ODT | 35.1 | 95% Confidence Interval 31.5 to 38.7 | percentage of participants | |
| Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose | Placebo | 26.8 | 95% Confidence Interval 23.5 to 30.2 | percentage of participants | |
| Percentage of Participants With Pain Relief at 2 Hours Post-dose | Rimegepant 75 mg ODT | 59.3 | 95% Confidence Interval 55.6 to 63.1 | percentage of participants | |
| Percentage of Participants With Pain Relief at 2 Hours Post-dose | Placebo | 43.3 | 95% Confidence Interval 39.5 to 47.0 | percentage of participants | |
| Percentage of Participants With Freedom From Functional Disability at 2 Hours Post-dose | Rimegepant 75 mg ODT | 38.1 | 95% Confidence Interval 34.4 to 41.8 | percentage of participants | |
| Percentage of Participants With Freedom From Functional Disability at 2 Hours Post-dose | Placebo | 25.8 | 95% Confidence Interval 22.5 to 29.1 | percentage of participants | |
| Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose | Rimegepant 75 mg ODT | 47.8 | 95% Confidence Interval 44.0 to 51.6 | percentage of participants | |
| Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose | Placebo | 27.7 | 95% Confidence Interval 24.4 to 31.1 | percentage of participants |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rimegepant 75 mg ODT | 732 | |
| Overall Study | STARTED | Placebo | 734 | |
| Overall Study | Treated | Rimegepant 75 mg ODT | 682 | |
| Overall Study | Treated | Placebo | 693 | |
| Overall Study | COMPLETED | Rimegepant 75 mg ODT | 679 | |
| Overall Study | COMPLETED | Placebo | 689 | |
| Overall Study | NOT COMPLETED | Rimegepant 75 mg ODT | 53 | |
| Overall Study | NOT COMPLETED | Placebo | 45 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rimegepant 75 mg ODT | 0 | 682 |
| Total, all-cause mortality | Placebo | 0 | 693 |
| Total, other adverse events | Rimegepant 75 mg ODT | 0 | 682 |
| Total, other adverse events | Placebo | 0 | 693 |
| Total, serious adverse events | Rimegepant 75 mg ODT | 0 | 682 |
| Total, serious adverse events | Placebo | 0 | 693 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rimegepant 75 mg ODT vs Placebo: deaths from any cause | Trial comparisons |
| Rimegepant 75 mg ODT vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03461757
GET https://conductscience.org/api/trials/v1/NCT03461757/registered?page=2