MigrainePhase 3NCT06103734
A Study to Learn About Zavegepant as a Treatment for Multiple Migraine Attacks in Adult Participants
A Phase 3 study testing Zavegepant 10 mg in people with Migraine, run by Pfizer.
Trial summary
The purpose of this study to show that zavegepant 10 milligrams given through the nose provides: freedom from pain, 2 hours after taking the medicine for the first migraine attack. consistent freedom from pain, 2 hours after taking the medicine across 4 separate migraine attacks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Zavegepant 10 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to 2 Aug 2027
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged 18 years or older.
- Participants with minimum 1 year history of migraine with age onset before 50 years of age.
Who cannot join
- 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 or anxiety disorder.
- Acute or chronic pain syndromes.
- Conditions that may affect the administration or absorption of the nasal product.
- History of alcohol abuse and/or illicit drug.
Show all 18Show fewer
- Other social, medical, or psychiatric condition that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Current use of any prohibited concomitant medication(s) or participants unwilling/unable to use a permitted concomitant medication(s)
- History of use of ergotamine medications or triptans on greater than/equal to 10 days per month on a regular basis for greater than/equal to 3 months. Or history of non-narcotic analgesic intake on greater than/equal to 15 days per month for greater than/equal to 3 months for other pain indications.
- Participation in clinical trial with non-biological investigational agents or interventional treatments (last study visit occurring) within the 30 days prior to Baseline Visit.
- Participation in clinical trial with biological investigational agents (last study visit occurring) within 90 days prior to Baseline Visit. Participation in any other investigational clinical trial while participating in this clinical trial.
- Previous participation in any zavegepant study within the last 2 years.
- ANY of the following findings at the Screening Visit and laboratory tests as assessed by the study-specific laboratory:
- Class 2 or Class 3 obesity, defined as body mass index >35 kg/m2.
- Estimated Globular Filtration Rate <30 mL/min/1.73 m2.
- Total bilirubin ≥1.5 × upper limit of normal.
- Liver transaminases ≥2.0 × upper limit of normal .
- Neutrophil count ≤1000/μL (or equivalent).
About this study
Official title: AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, 3-ARM, STUDY TO INVESTIGATE PAIN RESPONSE WITH INTRANASAL ZAVEGEPANT COMPARED WITH PLACEBO IN THE ACUTE TREATMENT OF MULTIPLE MIGRAINE ATTACKS IN ADULT PARTICIPANTS
The purpose of this study to show that zavegepant 10 milligrams given through the nose provides:
- freedom from pain, 2 hours after taking the medicine for the first migraine attack.
- consistent freedom from pain, 2 hours after taking the medicine across 4 separate migraine attacks.
Read more
This study is seeking participants who:
- are 18 years of age or older.
- have migraine attacks present for at least 1 year with age onset before 50 years old.
- have migraine attacks, on average, lasting about 4 to 72 hours if not treated.
- have 3 to 8 attacks per month but less than15 headache days per month.
If the participant is fit to take part in the study, the participant will receive either the study medicine zavegepant or placebo. A placebo looks like zavegepant but does not contain active ingredients. The study medicine will be given using nasal spray device containing a single amount of zavegepant or matching placebo.
The participants will be instructed to take the study medicine at home if participants have a migraine headache which reaches moderate or severe pain intensity. The participants are expected to treat up to 4 migraines of moderate to severe intensity.
After taking the study medicine, the participant is not allowed to take any other medications for at least 2 hours after taking the study medicine or placebo. Participant can take other medicines after the 2 hours if the migraine is still present. The participant is expected to record on a paper log all medications taken throughout the study.
The study duration is around 26 weeks. This includes a 28-day screening window, up to 20 weeks of treatment period, and a follow up visit at about 4 weeks after taking the study medicine the last time.
The participant is expected to come into the study center up to 4 times. There will be up to 3 telephone contacts including one after taking the study medicine the first time or Month 1 whichever comes first, at Month 3 if the participant is still in the study, and a safety follow-up.
During the study, the participant is expected to complete two sets of questions in an app on a smartphone. This step is done before and after taking the study medicine. The participants must rate:
- Pain
- Pain symptoms
- How the participants are feeling
- General well-being
- Conditions
- Migraine
- Being tested
- Zavegepant 10 mg, Placebo - Control 1, Placebo - Control 2
- Keywords
- CGRP antagonist, zavegepant, intranasal spray
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zavegepant 10 mgCombination product
4 doses of zavegpant 10 mg intranasal spray device
Placebo - Control 1Combination product
3 doses of placebo intranasal spray device and 1 dose of zavegepant 10 mg intranasal spray device
Placebo - Control 2Combination product
3 doses of placebo intranasal spray device and 1 dose of zavegepant 10 mg intranasal spray device
| Study group | Role | What they receive |
|---|---|---|
| Zavegepant 10 mg | Active comparator | This is the active arm where the participant will receive 4 doses of the zavegepant 10mg intranasal Receives: Combination Product: Zavegepant 10 mg |
| Placebo - Control 1 | Placebo comparator | This is one of the two placebo arms where the participant will receive 3 doses of placebo and 1 dose of zavegepant 10mg intranasal. Participant will not know which dose will be zavegepant. Receives: Combination Product: Placebo - Control 1 |
| Placebo - Control 2 | Placebo comparator | This is one of the two placebo arms where the participant will receive 3 doses of placebo and 1 dose of zavegepant 10mg intranasal. Participant will not know which dose will be zavegepant. Receives: Combination Product: Placebo - Control 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing efficacy of zavegepant with placebo in the acute treatment of migraine as measured by pain freedom at 2-hours post dose during the Double-Blind Treatment (DBT) Phase.
Pain levels will be assessed on a 4-point scale (0=none, 1=mild, 2=moderate, 3=severe) using an electronic handheld device. Pain freedom is measured as a pain level of none at 2 hours post-dose.
Measured: 2 hours post-dose
Consistency of efficacy of zavegepant across multiple attacks in the acute treatment of migraine as measured by pain freedom at 2-hours post dose during the DBT Phase.
Freedom from pain response, defined as pain freedom at 2 hours post-dose in ≥2 of 3 qualifying migraine attacks of moderate to severe in intensity.
Measured: 2 hours post-dose
Secondary outcomes (12)
Percentage of participants with freedom from Most Bothersome Symptoms (MBS) at 2 hours post-dose
Freedom from MBS is defined as the absence of the reported MBS.
Measured: 2 hours post-dose
Percentage of participants with pain relief at 2 hours post-dose
Pain relief is defined as intensity of none or mild.
Measured: 2 hours post-dose
Percentage of participants with pain relief at 15 minutes post-dose
Pain relief is defined as intensity of none or mild.
Measured: 15 minutes
Percentage of participants with consistency of pain relief for at least 2 of 3 qualifying attacks at 2 hours post-dose
Pain relief is defined as intensity of none or mild.
Measured: 2 hours post-dose
Percentage of participants with return to normal function at 2 hours post-dose
Return to normal function is defined as have a functional status of normal.
Measured: 2 hours post-dose
Percentage of participants with return to normal function at 30 minutes post-dose
Return to normal function is defined as have a functional status of normal.
Measured: 30 minutes post-dose
Percentage of participants with sustained pain freedom from 2 to 48 hours post-dose
Pain freedom is measured as a pain level of none. This outcomes measures pain freedom for the duration of 2 to 48 hours post-dose.
Measured: 2 to 48 hours post-dose
Percentage of participants in the triptan resistant/refractory (TRR) group with pain freedom at the 2 hours post-dose
TRR participants are those that have had inadequate responses from at least 2 different triptans as determined by the principal investigator. Pain freedom is measured as a pain level of none.
Measured: 2 hours post-dose
Percentage of participants with adverse events (AEs) of moderate or severe intensity
Measured: Duration of study (up to 26 weeks from signing of the inform consent to the safety follow-up period.
Percentage of participants with serious adverse events (SAEs)
Measured: Duration of study (up to 26 weeks from signing of the inform consent to the safety follow-up period.
Percentage of participants with local irritation AEs
Measured: Duration of study (up to 26 weeks from signing of the inform consent to the safety follow-up period.
Percentage of participants with grade 3 or 4 laboratory test abnormalities
Measured: Duration of study (up to 26 weeks from signing of the inform consent to the safety follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start15 Sep 2025 (estimated)
- Primary completion2 Aug 2027 (estimated)
- Study completion2 Aug 2027 (estimated)
Why it stopped: Strategic decision to cancel the study based on adjusted clinical development plan.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized by Interactive Web Response System in a 2:1:1 ratio of zavegepant:placebo:placebo stratified by 1)triptan resistant/refractory yes/no 2)stable migraine prophylactic medication yes/no
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103734
- Sponsor's protocol ID
- C5301007
- Other IDs
- 2023-505209-17-00, 2023
- Status last verified
- Jan 2026
- First submitted
- 6 Oct 2023
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, 3-ARM, STUDY TO INVESTIGATE PAIN RESPONSE WITH INTRANASAL ZAVEGEPANT COMPARED WITH PLACEBO IN THE ACUTE TREATMENT OF MULTIPLE MIGRAINE ATTACKS IN ADULT PARTICIPANTS
- ClinicalTrials.gov ID
- NCT06103734
- Acronym / sponsor ID
- C5301007
- Conditions
- Migraine
- Keywords
- CGRP antagonist, zavegepant, intranasal spray
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Strategic decision to cancel the study based on adjusted clinical development plan.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 2 Aug 2027 (estimated)
- Study completion
- 2 Aug 2027 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study to show that zavegepant 10 milligrams given through the nose provides:
- freedom from pain, 2 hours after taking the medicine for the first migraine attack.
- consistent freedom from pain, 2 hours after taking the medicine across 4 separate migraine attacks.
This study is seeking participants who:
- are 18 years of age or older.
- have migraine attacks present for at least 1 year with age onset before 50 years old.
- have migraine attacks, on average, lasting about 4 to 72 hours if not treated.
- have 3 to 8 attacks per month but less than15 headache days per month.
If the participant is fit to take part in the study, the participant will receive either the study medicine zavegepant or placebo. A placebo looks like zavegepant but does not contain active ingredients. The study medicine will be given using nasal spray device containing a single amount of zavegepant or matching placebo.
The participants will be instructed to take the study medicine at home if participants have a migraine headache which reaches moderate or severe pain intensity. The participants are expected to treat up to 4 migraines of moderate to severe intensity.
After taking the study medicine, the participant is not allowed to take any other medications for at least 2 hours after taking the study medicine or placebo. Participant can take other medicines after the 2 hours if the migraine is still present. The participant is expected to record on a paper log all medications taken throughout the study.
The study duration is around 26 weeks. This includes a 28-day screening window, up to 20 weeks of treatment period, and a follow up visit at about 4 weeks after taking the study medicine the last time.
The participant is expected to come into the study center up to 4 times. There will be up to 3 telephone contacts including one after taking the study medicine the first time or Month 1 whichever comes first, at Month 3 if the participant is still in the study, and a safety follow-up.
During the study, the participant is expected to complete two sets of questions in an app on a smartphone. This step is done before and after taking the study medicine. The participants must rate:
- Pain
- Pain symptoms
- How the participants are feeling
- General well-being
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Randomized by Interactive Web Response System in a 2:1:1 ratio of zavegepant:placebo:placebo stratified by 1)triptan resistant/refractory yes/no 2)stable migraine prophylactic medication yes/no
| Arm | Type | Receives |
|---|---|---|
| Zavegepant 10 mg | Active comparator | Combination Product: Zavegepant 10 mgThis is the active arm where the participant will receive 4 doses of the zavegepant 10mg intranasal |
| Placebo - Control 1 | Placebo comparator | Combination Product: Placebo - Control 1This is one of the two placebo arms where the participant will receive 3 doses of placebo and 1 dose of zavegepant 10mg intranasal. Participant will not know which dose will be zavegepant. |
| Placebo - Control 2 | Placebo comparator | Combination Product: Placebo - Control 2This is one of the two placebo arms where the participant will receive 3 doses of placebo and 1 dose of zavegepant 10mg intranasal. Participant will not know which dose will be zavegepant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants aged 18 years or older.
- Participants with minimum 1 year history of migraine with age onset before 50 years of age.
Key exclusion criteria (18 listed)
- 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 or anxiety disorder.
- Acute or chronic pain syndromes.
- Conditions that may affect the administration or absorption of the nasal product.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zavegepant 10 mg4 doses of zavegpant 10 mg intranasal spray device | Combination product | Zavegepant 10 mg |
| Placebo - Control 13 doses of placebo intranasal spray device and 1 dose of zavegepant 10 mg intranasal spray device | Combination product | Placebo - Control 1 |
| Placebo - Control 23 doses of placebo intranasal spray device and 1 dose of zavegepant 10 mg intranasal spray device | Combination product | Placebo - Control 2 |
Primary outcome
Comparing efficacy of zavegepant with placebo in the acute treatment of migraine as measured by pain freedom at 2-hours post dose during the Double-Blind Treatment (DBT) Phase.
Time frame: 2 hours post-dose
Pain levels will be assessed on a 4-point scale (0=none, 1=mild, 2=moderate, 3=severe) using an electronic handheld device. Pain freedom is measured as a pain level of none at 2 hours post-dose.
Consistency of efficacy of zavegepant across multiple attacks in the acute treatment of migraine as measured by pain freedom at 2-hours post dose during the DBT Phase.
Time frame: 2 hours post-dose
Freedom from pain response, defined as pain freedom at 2 hours post-dose in ≥2 of 3 qualifying migraine attacks of moderate to severe in intensity.
12 secondary outcomes
Percentage of participants with freedom from Most Bothersome Symptoms (MBS) at 2 hours post-dose
Time frame: 2 hours post-dose
Percentage of participants with pain relief at 2 hours post-dose
Time frame: 2 hours post-dose
Percentage of participants with pain relief at 15 minutes post-dose
Time frame: 15 minutes
Percentage of participants with consistency of pain relief for at least 2 of 3 qualifying attacks at 2 hours post-dose
Time frame: 2 hours post-dose
Percentage of participants with return to normal function at 2 hours post-dose
Time frame: 2 hours post-dose
Percentage of participants with return to normal function at 30 minutes post-dose
Time frame: 30 minutes post-dose
Percentage of participants with sustained pain freedom from 2 to 48 hours post-dose
Time frame: 2 to 48 hours post-dose
Percentage of participants in the triptan resistant/refractory (TRR) group with pain freedom at the 2 hours post-dose
Time frame: 2 hours post-dose
Percentage of participants with adverse events (AEs) of moderate or severe intensity
Time frame: Duration of study (up to 26 weeks from signing of the inform consent to the safety follow-up period.
Percentage of participants with serious adverse events (SAEs)
Time frame: Duration of study (up to 26 weeks from signing of the inform consent to the safety follow-up period.
Percentage of participants with local irritation AEs
Time frame: Duration of study (up to 26 weeks from signing of the inform consent to the safety follow-up period.
Percentage of participants with grade 3 or 4 laboratory test abnormalities
Time frame: Duration of study (up to 26 weeks from signing of the inform consent to the safety follow-up period.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zavegepant 10 mg in people with Migraine, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing efficacy of zavegepant with placebo in the acute treatment of migraine as measured by pain freedom at 2-hours post dose during the Double-Blind Treatment (DBT) Phase. (time frame: 2 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.