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NCT07861412

A Prospective Interventional Study of Intranasal Zavegepant for the Acute Treatment of Migraine

Sponsor: American Center for Psychiatry and Neurology

View on ClinicalTrials.gov

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 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2026-09-30

Completion Date

2028-03-30

Last Updated

2026-10-06

Healthy Volunteers

Conditions

Migraine

Interventions

OTHER

Patient Headache Diary

Patients will be asked to provide information on the first 2-3 headache attacks during the study

OTHER

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

DRUG

intranasal zavegepant

This intervention is free of charge for the participants of this trial.

Inclusion Criteria: 1. Participants diagnosed with migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd Edition, beta version 2. Participants with history of migraine attacks, defined as at least 2 migraine attacks per month during the 3 months prior to screening 3. Participants that signed the informed consent form 4. Participants must be 18 years of age or older at the time of consent 5. Participants must not be concurrently participating in another interventional clinical trial at the time of enrollment Exclusion Criteria: 1. Any previous exposure to zavegepant 2. Females of child-bearing potential who are pregnant or breastfeeding, or planning to become pregnant or breastfeed during the study 3. 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 4. Participants with history of nasal surgery in the 6 months preceding the screening visit 5. 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 6. 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 7. 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