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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