Trial · NCT04571060
Randomized Trial in Adult Participants With Acute Migraines
NCT04571060, Phase 3, Completed, Pfizer; results first posted 2023-03-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Randomized Trial in Adult Participants With Acute Migraines. Trials, record NCT04571060. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04571060
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Trial in Adult Participants With Acute Migraines
- NCT number
- NCT04571060
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,978 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Migraine
- Interventions
- Zavegepant, Placebo
- First posted
- 2020-09-30
- Last updated
- 2023-04-24
- Results first posted
- 2023-03-16
Source ClinicalTrials.gov
Registered outcomes19
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 clinical outcome assessment (eCOA) handheld device. Pain freedom was defined as pain level of none post-dose. |
| 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 immediately before dosing using the eCOA handheld device. Symptom status (absent, present) was assessed post-dose using the eCOA handheld device separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at on-study migraine attack 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 eCOA handheld device. Pain relief was defined as pain level of none or mild. |
| Secondary | Percentage of Participants Who Were Able to Function Normally at 2 Hours Post-dose | 2 hours post-dose | Functional disability level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) at on-study migraine attack onset. |
| Secondary | Percentage of Participants With Sustained Pain Relief From 2 Hours to 24 Post-dose | From 2 to 24 hours post-dose | Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 24 hours post-dose. |
| Secondary | Percentage of Participants With Sustained Pain Relief From 2 Hours to 48 Post-dose | From 2 to 48 hours post-dose | Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 48 hours post-dose. |
| Secondary | Percentage of Participants With Sustained Pain Freedom From 2 Hours to 24 Post-dose | From 2 to 24 hours post-dose | Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Sustained pain freedom was defined as pain level of none at 2 hours up to 24 hours post-dose. |
| Secondary | Percentage of Participants With Sustained Pain Freedom From 2 Hours to 48 Post-dose | From 2 to 48 hours post-dose | Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Sustained pain freedom was defined as pain level of none at 2 hours up to 48 hours post-dose. |
| Secondary | Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose | 2 hours post-dose | Phonophobia (sensitivity to sound) status was measured as absent or present in the eCOA handheld device. Freedom from phonophobia was defined as phonophobia absent post-dose in the subset of participants with phonophobia present at on-study migraine attack onset. |
| Secondary | Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose | 2 hours post-dose | Photophobia (sensitivity to light) status was measured as absent or present in the eCOA handheld device. Freedom from photophobia was defined as photophobia absent post-dose in the subset of participants with photophobia present at on-study migraine attack onset. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
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 | Efficacy Analysis Participants included treated participants who were randomized only once, had moderate to severe pain at the time of dosing, and had non-missing, post-dose efficacy data. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose | 2 hours post-dose | Efficacy Analysis Participants included treated participants who were randomized only once, had moderate to severe pain at the time of dosing, and had non-missing, post-dose efficacy data. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Pain Relief at 2 Hours Post-dose | 2 hours post-dose | Efficacy analysis participants were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Were Able to Function Normally at 2 Hours Post-dose | 2 hours post-dose | The Efficacy Analysis Participants with functional disability at the time of dosing were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Sustained Pain Relief From 2 Hours to 24 Post-dose | From 2 to 24 hours post-dose | Efficacy analysis participants were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Sustained Pain Relief From 2 Hours to 48 Post-dose | From 2 to 48 hours post-dose | Efficacy analysis participants were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Sustained Pain Freedom From 2 Hours to 24 Post-dose | From 2 to 24 hours post-dose | Efficacy analysis participants were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Sustained Pain Freedom From 2 Hours to 48 Post-dose | From 2 to 48 hours post-dose | Efficacy analysis participants were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose | 2 hours post-dose | Efficacy Analysis Participants with symptom of phonophobia present at the time of dosing were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose | 2 hours post-dose | Efficacy Analysis Participants with symptom of photophobia present at the time of dosing were analyzed. | Percentage of participants | NUMBER |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group38
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 | Zavegepant 10 mg | 23.6 | 95% Confidence Interval 20.3 to 26.9 | Percentage of participants | |
| Percentage of Participants With Freedom From Pain at 2 Hours Post-dose | Placebo | 14.9 | 95% Confidence Interval 12.1 to 17.6 | Percentage of participants | |
| Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose | Zavegepant 10 mg | 39.6 | 95% Confidence Interval 35.8 to 43.5 | Percentage of participants | |
| Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose | Placebo | 31.1 | 95% Confidence Interval 27.5 to 34.7 | Percentage of participants | |
| Percentage of Participants With Pain Relief at 2 Hours Post-dose | Zavegepant 10 mg | 58.7 | 95% Confidence Interval 54.9 to 62.6 | Percentage of participants | |
| Percentage of Participants With Pain Relief at 2 Hours Post-dose | Placebo | 49.7 | 95% Confidence Interval 45.8 to 53.5 | Percentage of participants | |
| Percentage of Participants Who Were Able to Function Normally at 2 Hours Post-dose | Zavegepant 10 mg | 35.8 | 95% Confidence Interval 31.9 to 39.7 | Percentage of participants | |
| Percentage of Participants Who Were Able to Function Normally at 2 Hours Post-dose | Placebo | 25.6 | 95% Confidence Interval 22.1 to 29.1 | Percentage of participants | |
| Percentage of Participants With Sustained Pain Relief From 2 Hours to 24 Post-dose | Zavegepant 10 mg | 40.6 | 95% Confidence Interval 36.8 to 44.5 | Percentage of participants | |
| Percentage of Participants With Sustained Pain Relief From 2 Hours to 24 Post-dose | Placebo | 33.0 | 95% Confidence Interval 29.3 to 36.6 | Percentage of participants |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zavegepant 10 mg | 703 | |
| Overall Study | STARTED | Placebo | 702 | |
| Overall Study | Treated | Zavegepant 10 mg | 629 | |
| Overall Study | Treated | Placebo | 653 | |
| Overall Study | Efficacy Analysis Set Participants | Zavegepant 10 mg | 623 | |
| Overall Study | Efficacy Analysis Set Participants | Placebo | 646 | |
| Overall Study | COMPLETED | Zavegepant 10 mg | 622 | |
| Overall Study | COMPLETED | Placebo | 653 | |
| Overall Study | NOT COMPLETED | Zavegepant 10 mg | 81 | |
| Overall Study | NOT COMPLETED | Placebo | 49 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dysgeusia | Nervous system disorders | Zavegepant 10 mg | 129 | 629 | |
| other | Dysgeusia | Nervous system disorders | Placebo | 31 | 653 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zavegepant 10 mg | 0 | 629 |
| Total, all-cause mortality | Placebo | 0 | 653 |
| Total, other adverse events | Zavegepant 10 mg | 129 | 629 |
| Total, other adverse events | Placebo | 31 | 653 |
| Total, serious adverse events | Zavegepant 10 mg | 0 | 629 |
| Total, serious adverse events | Placebo | 0 | 653 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36804093 | DERIVED |
Source PubMed
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 |
|---|---|
| Zavegepant 10 mg vs Placebo: deaths from any cause | Trial comparisons |
| Zavegepant 10 mg 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/NCT04571060
GET https://conductscience.org/api/trials/v1/NCT04571060/results?page=2