Trial · NCT03872453
Acute Treatment Trial in Adult Subjects With Migraines
NCT03872453, Phase 2, Phase 3, Completed, Pfizer; results first posted 2022-10-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Acute Treatment Trial in Adult Subjects With Migraines. Trials, record NCT03872453. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03872453
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Acute Treatment Trial in Adult Subjects With Migraines
- NCT number
- NCT03872453
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 2,154 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Migraine
- Interventions
- Zavegepant, Zavegepant matching placebo, Intranasal Aptar Pharma Unit Dose System
- First posted
- 2019-03-13
- Last updated
- 2023-09-25
- Results first posted
- 2022-10-13
Source ClinicalTrials.gov
Registered outcomes17
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 at migraine onset 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 disbaility 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 Rescue Medication Use Within 24 Hours Post-dose | Through 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 eCOA handheld device) 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 (for example, metoclopramide or promethazine), or baclofen. The participant's use of rescue medication was recorded by the site on a case report form. |
| 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. |
| 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 Pain Relief at 60 Minutes Post-dose | 60 minutes 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 60 Minutes Post-dose | 60 minutes post-dose | Functional disbaility 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 Pain Relief at 30 Minutes Post-dose | 30 minutes 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. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
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 | mITT participants included treated participants who were randomized only once, had moderate to severe pain at on-study migraine attack onset, and had non-missing, post-baseline 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 | The mITT participants were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Pain Relief at 2 Hours Post-dose | 2 hours post-dose | The mITT 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 mITT participants with functional disability at on-study migraine attack onset were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose | Through 24 hours post-dose | The mITT participants were analyzed. Participants with rescue medication start date less than or equal to (≤) study drug start date + 1 day and missing rescue medication start time were excluded. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose | 2 hours post-dose | The mITT participants with symptom of photophobia present at on-study migraine attack onset were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose | 2 hours post-dose | The mITT participants with symptom of phonophobia present at on-study migraine attack onset were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Pain Relief at 60 Minutes Post-dose | 60 minutes post-dose | The mITT participants were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Were Able to Function Normally at 60 Minutes Post-dose | 60 minutes post-dose | The mITT participants with functional disability at on-study migraine attack onset were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Pain Relief at 30 Minutes Post-dose | 30 minutes post-dose | The mITT participants were analyzed. | percentage of participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group68
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 5 mg | 19.6 | 98.3% Confidence Interval 14.8 to 24.5 | percentage of participants | |
| Percentage of Participants With Freedom From Pain at 2 Hours Post-dose | Zavegepant 10 mg | 22.5 | 98.3% Confidence Interval 17.5 to 27.6 | percentage of participants | |
| Percentage of Participants With Freedom From Pain at 2 Hours Post-dose | Zavegepant 20 mg | 23.1 | 98.3% Confidence Interval 18.1 to 28.2 | percentage of participants | |
| Percentage of Participants With Freedom From Pain at 2 Hours Post-dose | Placebo | 15.5 | 98.3% Confidence Interval 11.1 to 19.8 | percentage of participants | |
| Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose | Zavegepant 5 mg | 39.0 | 98.3% Confidence Interval 33.1 to 45.0 | percentage of participants | |
| Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose | Zavegepant 10 mg | 41.9 | 98.3% Confidence Interval 36.0 to 47.9 | percentage of participants | |
| Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose | Zavegepant 20 mg | 42.5 | 98.3% Confidence Interval 36.6 to 48.4 | percentage of participants | |
| Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose | Placebo | 33.7 | 98.3% Confidence Interval 28.0 to 39.3 | percentage of participants | |
| Percentage of Participants With Pain Relief at 2 Hours Post-dose | Zavegepant 5 mg | 57.9 | 98.3% Confidence Interval 51.9 to 63.9 | percentage of participants | |
| Percentage of Participants With Pain Relief at 2 Hours Post-dose | Zavegepant 10 mg | 60.6 | 98.3% Confidence Interval 54.7 to 66.5 | percentage of participants |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zavegepant 5 mg | 418 | |
| Overall Study | STARTED | Zavegepant 10 mg | 417 | |
| Overall Study | STARTED | Zavegepant 20 mg | 418 | |
| Overall Study | STARTED | Placebo | 420 | |
| Overall Study | Treated | Zavegepant 5 mg | 388 | |
| Overall Study | Treated | Zavegepant 10 mg | 394 | |
| Overall Study | Treated | Zavegepant 20 mg | 403 | |
| Overall Study | Treated | Placebo | 403 | |
| Overall Study | Modified Intent-to-Treat (mITT) Participants | Zavegepant 5 mg | 387 | |
| Overall Study | Modified Intent-to-Treat (mITT) Participants | Zavegepant 10 mg | 391 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events16
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 5 mg | 54 | 388 | |
| other | Dysgeusia | Nervous system disorders | Zavegepant 10 mg | 53 | 394 | |
| other | Dysgeusia | Nervous system disorders | Zavegepant 20 mg | 65 | 403 | |
| other | Dysgeusia | Nervous system disorders | Placebo | 14 | 403 | |
| other | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Zavegepant 5 mg | 5 | 388 | |
| other | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Zavegepant 10 mg | 5 | 394 | |
| other | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Zavegepant 20 mg | 21 | 403 | |
| other | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 403 | |
| serious | Vestibular migraine | Nervous system disorders | Zavegepant 5 mg | 0 | 388 | |
| serious | Vestibular migraine | Nervous system disorders | Zavegepant 10 mg | 0 | 394 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zavegepant 5 mg | 0 | 388 |
| Total, all-cause mortality | Zavegepant 10 mg | 0 | 394 |
| Total, all-cause mortality | Zavegepant 20 mg | 0 | 403 |
| Total, all-cause mortality | Placebo | 0 | 403 |
| Total, other adverse events | Zavegepant 5 mg | 57 | 388 |
| Total, other adverse events | Zavegepant 10 mg | 58 | 394 |
| Total, other adverse events | Zavegepant 20 mg | 81 | 403 |
| Total, other adverse events | Placebo | 15 | 403 |
| Total, serious adverse events | Zavegepant 5 mg | 0 | 388 |
| Total, serious adverse events | Zavegepant 10 mg | 1 | 394 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03872453
GET https://conductscience.org/api/trials/v1/NCT03872453/results?page=2