Phase 3
N=1,414
A Study to Learn About Zavegepant as the Acute Treatment of Migraine in Asian Adults
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT05989048 ↗Enrolled (actual)
1,414
Serious AEs
0.2%
Results posted
May 2026
Primary outcome: Primary: Percentage of Participants With Pain Freedom at 2 Hours Post-dose — 23.2; 14.1 Percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Zavegepant (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Pain Freedom at 2 Hours Post-dose |
23.2; 14.1 | <0.0001 sig |
| PRIMARY Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose |
52.7; 39.9 | <0.0001 sig |
| SECONDARY Percentage of Participants With Pain Relief at 15 Minutes Post-dose |
14.5; 10.9 | =0.0480 sig |
| SECONDARY Percentage of Participants With Pain Relief at 30 Minutes Post-dose |
30.3; 24.1 | =0.0100 sig |
| SECONDARY Percentage of Participants With Pain Relief at 2 Hours Post-dose |
67.2; 51.0 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Returned to Normal Function at 2 Hours Post-dose |
38.0; 24.4 | <0.0001 sig |
| SECONDARY Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose |
55.8; 39.8 | <0.0001 sig |
| SECONDARY Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose |
53.3; 38.6 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Returned to Normal Function at 30 Minutes Post-dose |
8.3; 6.3 | =0.1677 |
| SECONDARY Percentage of Participants Who Returned to Normal Function at 60 Minutes Post-dose |
22.3; 14.6 | =0.0005 sig |
| SECONDARY Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose |
52.1; 36.3 | — |
| SECONDARY Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose |
49.1; 38.0 | — |
| SECONDARY Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose |
64.2; 51.3 | — |
| SECONDARY Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose |
17.7; 11.2 | — |
| SECONDARY Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose |
17.3; 11.1 | — |
| SECONDARY Percentage of Participants With Pain Relapse at Any Time Point After 2 Hours Post-dose to 48 Hours Post-dose |
29.3; 22.3 | — |
| SECONDARY Percentage of Participants Taking Rescue Medication Within 24 Hours Post-dose |
17.1; 24.4 | — |
| SECONDARY Percentage of Participants With Pain Relief at 60 Minutes Post-dose |
48.6; 41.9 | — |
| SECONDARY Percentage of Participants Who Returned to Normal Function at 15 Minutes Post-dose |
4.1; 2.7 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) of Moderate or Severe Intensity: On-Treatment Period |
9; 6 | — |
| SECONDARY Number of Participants With AEs of Moderate or Severe Intensity: Follow-up Period |
8; 3 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs): On-Treatment Period |
2; 1 | — |
| SECONDARY Number of Participants With SAEs: Follow-up Period |
3; 0 | — |
| SECONDARY Number of Participants With Local Irritation AEs: On-Treatment Period |
41; 6 | — |
| SECONDARY Number of Participants With Local Irritation AEs: Follow-up Period |
0; 0 | — |
| SECONDARY Number of Participants With Grade 3 to 4 Hematological Test Abnormalities: On-Treatment Period |
1; 0; 1; 0; 2; 2 | — |
| SECONDARY Number of Participants With Grade 3 to 4 Clinical Chemistry Test Abnormalities: On-Treatment Period |
4; 4; 1; 0 | — |
Summary
The purpose of this study is to learn how safe and effective zavegepant is compared to placebo in the acute treatment of migraine in Asian adults. Migraine is a very painful headache with other associated symptoms such as nausea, photophobia and phonophobia. A placebo is a harmless treatment that has no medical effect.
This study is seeking for participants who:
* have at least 1 year of migraine history before entering the study.
* have 2 to 8 migraine headache attacks of moderate or severe intensity in each of the 3 months before entering the study.
* have less than 15 days with headaches in each of the 3 months before entering the study. The headaches could be either due to migraine or not.
The participants in this study will receive zavegepant or placebo through intranasal route. Intranasal means medicine which is given through nose. Zavegepant or placebo will be taken if the participants have a migraine headache of moderate or severe intensity.
The study will compare the experiences of people receiving zavegepant to those of the people receiving placebo. This will help see if zavegepant is safe and effective in Asian adults.
Participants will be in this study for up to about 16 weeks. Participants will have 3 study visits at the study clinic and 1 through telephone contact.
Eligibility Criteria
Inclusion Criteria
- Asian participants aged 18 years or older at screening.
- Participants with minimum 1 year history of migraine (with or without aura) prior to the Screening Visit, consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:
- Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
- Migraine attacks, on average, lasting about 4-72 hours if untreated.
- Not more than 8 attacks of moderate or severe pain intensity per month within last 3 months.
- Participants must be able to distinguish migraine attacks from tension/cluster headaches.
- At least 2 consistent migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and throughout the Screening Phase (participant self-report).
- Less than 15 days with headaches (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and throughout the Screening Phase (participant self-report).
- Participants on prophylactic migraine medication are permitted to remain on therapy if they have been on a stable dose for at least 3 months prior to Screening Visit, and if the dose is not expected to change through the End of Treatment Visit.
- Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria.
Exclusion Criteria
- History of retinal migraine, basilar migraine or hemiplegic migraine.
- History or current evidence of uncontrolled, unstable or recently diagnosed cardiovascular or cardiometabolic disease.
- Major depressive disorder, anxiety disorder, or other significant psychiatric disorder.
- Acute or chronic pain syndromes, psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that interfere with study assessments.
- Conditions that may affect the administration or absorption of the nasal product.
- Medication overuse headaches.
Data sourced from ClinicalTrials.gov (NCT05989048). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.