MigraineNCT07861412
A Prospective Interventional Study of Intranasal Zavegepant for the Acute Treatment of Migraine
A study testing Patient Headache Diary, Patient Reported Outcome and intranasal zavegepant in people with Migraine, run by American Center for Psychiatry and Neurology.
Trial summary
Primary Objective: To evaluate the effectiveness of zavegepant in real-world settings for the acute treatment of migraine. Effectiveness will be evaluated based on the treatment of the first acute migraine attack with zavegepant, in order to capture clinically meaningful treatment response under real-world conditions… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Patient Headache Diary, Patient Reported Outcome and intranasal zavegepant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 30 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 diagnosed with migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd Edition, beta version
- Participants with history of migraine attacks, defined as at least 2 migraine attacks per month during the 3 months prior to screening
- Participants that signed the informed consent form
- Participants must be 18 years of age or older at the time of consent
- Participants must not be concurrently participating in another interventional clinical trial at the time of enrollment
Who cannot join
- Any previous exposure to zavegepant
- Females of child-bearing potential who are pregnant or breastfeeding, or planning to become pregnant or breastfeed during the study
- Participants who, in the opinion of the investigator, are not suitable for study participation or are unable to comply with study procedures or complete the required one-month follow up, including due to severe visual, auditory, language, cognitive, or consciousness impairments
- Participants with history of nasal surgery in the 6 months preceding the screening visit
- Participants with evidence at screening of significant nasal conditions that may affect the administration or absorption of the nasal product (e.g. severe septum deviation, nasal deformity or blockage, inflammation, perforation, mucosal erosion or ulceration, polyposis, nasal trauma) as evaluated by the investigator
- Other conditions that, in the opinion of the investigator, may interfere with study participation, data quality, or the interpretation of study results, including but not limited to unstable psychiatric disorders, clinically significant or unstable cardiovascular conditions, or severe hepatic or renal impairment
- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Primary Objective:
To evaluate the effectiveness of zavegepant in real-world settings for the acute treatment of migraine. Effectiveness will be evaluated based on the treatment of the first acute migraine attack with zavegepant, in order to capture clinically meaningful treatment response under real-world conditions while minimizing patient burden and missing data. Clinically meaningful treatment response is defined as: An improvement in a patient's condition that is large enough to be perceived as beneficial and to have a tangible impact on how the patient feels and functions.
Read more
Secondary Objectives:
To further evaluate the effectiveness of zavegepant for the acute treatment of migraine in real-world settings, including:
- Pain freedom
- Absence of the patient-identified most bothersome symptom (MBS)
- Absence of individual migraine-associated symptoms (phonophobia, photophobia, and nausea) at 1 hour and 2 hours post dose, among participants with symptoms present at baseline
- Sustained pain relief
- Return to normal function
- Rescue medication use
Exploratory objectives include:
- Evaluation of early treatment response at post-dose timepoints up to 60 minutes
- Assessment of consistency of treatment effect across multiple migraine attacks
- Time to meaningful pain relief as reported by the participant for the first treated attack
Patient-Reported Outcomes:
Patient-reported outcomes will be collected over a 3-month period to assess the longitudinal patient experience and sustained treatment impact in routine clinical practice.
Read the detailed description
This is a prospective, multicenter, interventional study conducted in a real-world setting, enrolling adult participants receiving zavegepant for the acute treatment of migraine. The study is classified as interventional due to the requirement for participants to complete protocol-mandated questionnaires and a patient diary. No protocol-specified therapeutic or diagnostic interventions are required. Participants management will otherwise follow routine clinical practice, and participants will receive study medication at no cost. Recruitment is planned from September 2026 through September 30, 2027. The index date is defined as the date on which the participant signs the Informed Consent Document (ICD). Eligible participants will receive a supply of study medication (up to 54 doses) at the index date. Additional medication may be provided at the investigator's discretion for participants with a higher frequency of migraine attacks, in accordance with study procedures.
Each participant will be followed for approximately 4 months, including a 3-month treatment period and a 1-month follow-up period. Approximately 250 adult participants are planned for enrollment.Collected data will include demographics, migraine history, substance use, patient-reported headache episodes recorded in a paper diary, and patient-reported outcomes (PROs) documented in case report forms (CRFs). PRO assessments will be completed during on-site visits.
Treatment Initiation: At the start of the treatment period, a one-week washout period is required prior to the first dose of zavegepant. During this period, participants should not use any acute migraine medications; however, short-acting triptans may be used as rescue medication if needed. Long-acting triptans (e.g., naratriptan and frovatriptan) must not be used. Participants without migraine attacks during the washout period may initiate treatment at their next migraine attack. Any ongoing preventive migraine treatments should remain stable throughout the washout period and the entire three-month treatment period. Treatment Administration and Migraine Attack Management: For the first three evaluable migraine attacks treated during the study, participants are required to complete the patient diary as described in section related to Patient Diary. Zavegepant should be administered only when the migraine headache reaches a moderate to severe level of pain. No other acute migraine medication should be taken prior to zavegepant administration. Rescue medication may be used if needed, but only ≥2 hours after dosing with zavegepant. For subsequent migraine attacks, participants may administer zavegepant at any time they consider appropriate, regardless of headache pain intensity or stage, including during mild pain or the prodromal phase (i.e., early symptoms indicating the onset of a migraine attack).
At Visit 1, participants will be dispensed a total of 54 doses of zavegepant, corresponding to a planned supply of 18 doses per month. This quantity is expected, in general, to cover treatment needs for the duration of the study. If a participant requires more than 18 doses within a given month, the Co-Investigator should notify the Principal Investigator to arrange additional supply in accordance with study procedures.
The primary assessment of effectiveness will focus on the first treated migraine attack, based on pain relief at 2 hours post dose.
Secondary assessments will also include additional measures of effectiveness, including pain freedom, absence of the most bothersome symptom (MBS), resolution of associated symptoms, sustained pain response, return to normal function, and use of rescue medication.
Effectiveness will be evaluated using patient-reported outcomes, including changes from Visit 1 to Visit 4 in headache impact (HIT-6), migraine-related disability (MIDAS), work productivity (WPAI: Migraine 2.0), and mood-related symptoms (PHQ-4 and GAD-7), as well as overall treatment improvement assessed by PGI-I at Visit 4.
Exploratory assessments will include early treatment response (up to 60 minutes post-dose), consistency of treatment effect across multiple attacks, and time to meaningful pain relief for the first treated attack. Analyses may include up to the first three evaluable migraine attacks treated with zavegepant, with a minimum 48-hour interval between treated attacks.
Rescue medication is defined as the use of any additional acute migraine treatment following zavegepant administration to manage insufficient symptom relief.
All analyses will be based on observed data; missing data will not be imputed. Denominators will be defined per endpoint. All study assessments are consistent with routine clinical practice or standard care for the target population.
- Conditions
- Migraine
- Being tested
- Patient Headache Diary, Patient Reported Outcome, intranasal zavegepant
- Keywords
- Migraine, Migraine treatment, Zavegepant
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Headache DiaryOther
Patients will be asked to provide information on the first 2-3 headache attacks during the study
Patient Reported OutcomeOther
- Headache Impact Test (HIT-6) to assess the impact of headache on daily functioning and quality of life, collected at screening and V 4
- Migraine Disability Assessment (MIDAS) to evaluate migraine-related disability and functional impairment, collected at screening and V 4
- Patient Global Impression of Improvement (PGI-I) to assess the participants overall perception of treatment benefit, collected V 4
- Work Productivity and Activity Impairment (WPAI: Migraine 2.0) questionnaire to evaluate the effect of migraine on work productivity and daily activities. collected at screening and V 4
- The Patient Health Questionnaire-4 (PHQ-4) is used to assess the presence and severity of both depressive and anxiety symptoms, collected at screening and V 4
- Generalized Anxiety Disorder-7 (GAD-7) to evaluate the presence and severity of anxiety symptoms, collected at screening and V 4 has context menu
intranasal zavegepantDrug
This intervention is free of charge for the participants of this trial.
| Study group | Role | What they receive |
|---|---|---|
| Not applicable as all the patients within the study will receive the same intervention | Other | Not described Receives: Other: Patient Headache Diary; Other: Patient Reported Outcome; Drug: intranasal zavegepant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants reporting pain relief at 2 hours post-dose following the first use of zavegepant for an acute migraine attack.
Pain relief is defined as a reduction of at least one category in pain intensity from baseline to the specified post-dose timepoint (e.g., severe to moderate, moderate to mild, or mild to none). The primary endpoint will be assessed based on the first treated acute migraine attack.
Measured: From enrollment to end of treatment at month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm interventional study with no comparator or control group. All enrolled participants receive intranasal zavegepant for the acute treatment of migraine in accordance with routine clinical practice.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Center for Psychiatry and Neurology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861412
- Sponsor's protocol ID
- RC 103951443
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Interventional Study of Intranasal Zavegepant for the Acute Treatment of Migraine
- ClinicalTrials.gov ID
- NCT07861412
- Acronym / sponsor ID
- RC 103951443
- Conditions
- Migraine
- Keywords
- Migraine, Migraine treatment, Zavegepant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- American Center for Psychiatry and NeurologyUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 6 Oct 2026 (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.
Primary Objective:
To evaluate the effectiveness of zavegepant in real-world settings for the acute treatment of migraine. Effectiveness will be evaluated based on the treatment of the first acute migraine attack with zavegepant, in order to capture clinically meaningful treatment response under real-world conditions while minimizing patient burden and missing data. Clinically meaningful treatment response is defined as: An improvement in a patient's condition that is large enough to be perceived as beneficial and to have a tangible impact on how the patient feels and functions.
Secondary Objectives:
To further evaluate the effectiveness of zavegepant for the acute treatment of migraine in real-world settings, including:
- Pain freedom
- Absence of the patient-identified most bothersome symptom (MBS)
- Absence of individual migraine-associated symptoms (phonophobia, photophobia, and nausea) at 1 hour and 2 hours post dose, among participants with symptoms present at baseline
- Sustained pain relief
- Return to normal function
- Rescue medication use
Exploratory objectives include:
- Evaluation of early treatment response at post-dose timepoints up to 60 minutes
- Assessment of consistency of treatment effect across multiple migraine attacks
- Time to meaningful pain relief as reported by the participant for the first treated attack
Patient-Reported Outcomes:
Patient-reported outcomes will be collected over a 3-month period to assess the longitudinal patient experience and sustained treatment impact in routine clinical practice.
Detailed description
This is a prospective, multicenter, interventional study conducted in a real-world setting, enrolling adult participants receiving zavegepant for the acute treatment of migraine. The study is classified as interventional due to the requirement for participants to complete protocol-mandated questionnaires and a patient diary. No protocol-specified therapeutic or diagnostic interventions are required. Participants management will otherwise follow routine clinical practice, and participants will receive study medication at no cost. Recruitment is planned from September 2026 through September 30, 2027. The index date is defined as the date on which the participant signs the Informed Consent Document (ICD). Eligible participants will receive a supply of study medication (up to 54 doses) at the index date. Additional medication may be provided at the investigator's discretion for participants with a higher frequency of migraine attacks, in accordance with study procedures.
Each participant will be followed for approximately 4 months, including a 3-month treatment period and a 1-month follow-up period. Approximately 250 adult participants are planned for enrollment.Collected data will include demographics, migraine history, substance use, patient-reported headache episodes recorded in a paper diary, and patient-reported outcomes (PROs) documented in case report forms (CRFs). PRO assessments will be completed during on-site visits.
Treatment Initiation: At the start of the treatment period, a one-week washout period is required prior to the first dose of zavegepant. During this period, participants should not use any acute migraine medications; however, short-acting triptans may be used as rescue medication if needed. Long-acting triptans (e.g., naratriptan and frovatriptan) must not be used. Participants without migraine attacks during the washout period may initiate treatment at their next migraine attack. Any ongoing preventive migraine treatments should remain stable throughout the washout period and the entire three-month treatment period. Treatment Administration and Migraine Attack Management: For the first three evaluable migraine attacks treated during the study, participants are required to complete the patient diary as described in section related to Patient Diary. Zavegepant should be administered only when the migraine headache reaches a moderate to severe level of pain. No other acute migraine medication should be taken prior to zavegepant administration. Rescue medication may be used if needed, but only ≥2 hours after dosing with zavegepant. For subsequent migraine attacks, participants may administer zavegepant at any time they consider appropriate, regardless of headache pain intensity or stage, including during mild pain or the prodromal phase (i.e., early symptoms indicating the onset of a migraine attack).
At Visit 1, participants will be dispensed a total of 54 doses of zavegepant, corresponding to a planned supply of 18 doses per month. This quantity is expected, in general, to cover treatment needs for the duration of the study. If a participant requires more than 18 doses within a given month, the Co-Investigator should notify the Principal Investigator to arrange additional supply in accordance with study procedures.
The primary assessment of effectiveness will focus on the first treated migraine attack, based on pain relief at 2 hours post dose.
Secondary assessments will also include additional measures of effectiveness, including pain freedom, absence of the most bothersome symptom (MBS), resolution of associated symptoms, sustained pain response, return to normal function, and use of rescue medication.
Effectiveness will be evaluated using patient-reported outcomes, including changes from Visit 1 to Visit 4 in headache impact (HIT-6), migraine-related disability (MIDAS), work productivity (WPAI: Migraine 2.0), and mood-related symptoms (PHQ-4 and GAD-7), as well as overall treatment improvement assessed by PGI-I at Visit 4.
Exploratory assessments will include early treatment response (up to 60 minutes post-dose), consistency of treatment effect across multiple attacks, and time to meaningful pain relief for the first treated attack. Analyses may include up to the first three evaluable migraine attacks treated with zavegepant, with a minimum 48-hour interval between treated attacks.
Rescue medication is defined as the use of any additional acute migraine treatment following zavegepant administration to manage insufficient symptom relief.
All analyses will be based on observed data; missing data will not be imputed. Denominators will be defined per endpoint. All study assessments are consistent with routine clinical practice or standard care for the target population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm interventional study with no comparator or control group. All enrolled participants receive intranasal zavegepant for the acute treatment of migraine in accordance with routine clinical practice.
| Arm | Type | Receives |
|---|---|---|
| Not applicable as all the patients within the study will receive the same intervention | Other | Other: Patient Headache Diary, Other: Patient Reported Outcome, Drug: intranasal zavegepant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants diagnosed with migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd Edition, beta version
- Participants with history of migraine attacks, defined as at least 2 migraine attacks per month during the 3 months prior to screening
- Participants that signed the informed consent form
- Participants must be 18 years of age or older at the time of consent
- Participants must not be concurrently participating in another interventional clinical trial at the time of enrollment
Key exclusion criteria (7 listed)
- Any previous exposure to zavegepant
- Females of child-bearing potential who are pregnant or breastfeeding, or planning to become pregnant or breastfeed during the study
- Participants who, in the opinion of the investigator, are not suitable for study participation or are unable to comply with study procedures or complete the required one-month follow up, including due to severe visual, auditory, language, cognitive, or consciousness impairments
- Participants with history of nasal surgery in the 6 months preceding the screening visit
- Participants with evidence at screening of significant nasal conditions that may affect the administration or absorption of the nasal product (e.g. severe septum deviation, nasal deformity or blockage, inflammation, perforation, mucosal erosion or ulceration, polyposis, nasal trauma) as evaluated by the investigator
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 |
|---|---|---|
| Patient Headache DiaryPatients will be asked to provide information on the first 2-3 headache attacks during the study | Other | Not applicable as all the patients within the study will receive the same intervention |
| Patient Reported Outcome* Headache Impact Test (HIT-6) to assess the impact of headache on daily functioning and quality of life, collected at screening and V 4 * Migraine Disability Assessment (MIDAS) to evaluate migraine-related disability and functional impairment, collected at screening and V 4 * Patient Global Impression of Improvement (PGI-I) to assess the participants overall perception of treatment benefit, collected V 4 * Work Productivity and Activity Impairment (WPAI: Migraine 2.0) questionnaire to evaluate the effect of migraine on work productivity and daily activities. collected at screening and V 4 * The Patient Health Questionnaire-4 (PHQ-4) is used to assess the presence and severity of both depressive and anxiety symptoms, collected at screening and V 4 * Generalized Anxiety Disorder-7 (GAD-7) to evaluate the presence and severity of anxiety symptoms, collected at screening and V 4 has context menu | Other | Not applicable as all the patients within the study will receive the same intervention |
| intranasal zavegepantThis intervention is free of charge for the participants of this trial. | Drug | Not applicable as all the patients within the study will receive the same intervention |
Primary outcome
Percentage of participants reporting pain relief at 2 hours post-dose following the first use of zavegepant for an acute migraine attack.
Time frame: From enrollment to end of treatment at month 4
Pain relief is defined as a reduction of at least one category in pain intensity from baseline to the specified post-dose timepoint (e.g., severe to moderate, moderate to mild, or mild to none). The primary endpoint will be assessed based on the first treated acute migraine attack.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Headache Diary, Patient Reported Outcome and intranasal zavegepant in people with Migraine, run by American Center for Psychiatry and Neurology.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 6 Oct 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reem Suliman, MSc (+97124198039, research.officer@americancenteruae.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants reporting pain relief at 2 hours post-dose following the first use of zavegepant for an acute migraine attack. (time frame: From enrollment to end of treatment at month 4). 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 6 Oct 2026.