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

NCT ID
NCT07861412
Registry status
Not yet recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
American Center for Psychiatry and Neurology
Conditions
Migraine

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

Enrollment: 250 participants (Estimated).

What is being studied

  • Intervention: Data Collection
  • Intervention: Environment and Public Health
  • Intervention: Epidemiologic Methods
  • Intervention: Health Care Economics and Organizations
  • Intervention: Health Care Evaluation Mechanisms
  • Intervention: Health Care Quality, Access, and Evaluation
  • Intervention: Health Care Surveys
  • Intervention: Health Planning
  • Intervention: Health Services Administration
  • Intervention: Health Services Research
  • Drug: intranasal zavegepant
  • Intervention: Investigative Techniques
  • Intervention: Outcome and Process Assessment, Health Care
  • Intervention: Outcome Assessment, Health Care
  • Other: Patient Headache Diary
  • Intervention: Patient Outcome Assessment
  • Other: Patient Reported Outcome
  • Intervention: Patient Reported Outcome Measures
  • Intervention: Public Health
  • Intervention: Quality of Health Care
  • Intervention: Surveys and Questionnaires

Who may be eligible

Ages
18 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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

Study locations

No study locations are listed in the registry data.

Study details

Start date
September 30, 2026
Primary completion date
December 30, 2027
Completion date
March 30, 2028
First posted
October 6, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07861412
Registry last updated
October 6, 2026
QualifiedStudies registry data refreshed
October 12, 2026
QualifiedStudies record fetched
October 12, 2026

View NCT07861412 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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