A Phase 2/3 Open-label, Long-Term, Safety Trial of BHV3500 (Zavegepant*) Intranasal (IN) for the Acute Treatment of Migraine
ClinicalTrials.gov processed this data on May 16, 2023. Link to the current ClinicalTrials.gov record.Recruitment Status
COMPLETED - HAS RESULTS(See Contacts and Locations)
Verified May 2023 by Pfizer
Sponsor
PfizerInformation Provided by (Responsible Party)
PfizerClinicaltrials.gov Identifier
NCT04408794Other Study ID Numbers: BHV3500-202
First Submitted: May 26, 2020
First Posted: May 29, 2020
Results First Posted: March 16, 2023
Last Update Posted: May 18, 2023
Last Verified: May 2023
History of Changes
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Study Description
Not Provided| Condition or Disease | Intervention/Treatment |
|---|---|
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Study Design
| Study Type | Interventional |
|---|---|
| Actual Enrollment | 974 participants |
| Design Allocation | N/A |
| Interventional Model | Single Group Assignment |
| Masking | None (Open Label) |
| Primary Purpose | Treatment |
| Official Title | A Phase 2/3 Open-label, Long-Term, Safety Trial of BHV3500 (Zavegepant*) Intranasal (IN) for the Acute Treatment of Migraine |
| Study Start Date | June 29, 2020 |
| Actual Primary Completion Date | December 9, 2021 |
| Actual Study Completion Date | December 23, 2021 |
Groups and Cohorts
| Group/ Cohort | Intervention/ Treatment |
|---|---|
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Outcome Measures
Primary Outcome Measures
- Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading To Discontinuation [From study drug dosing up to the end of the study (up to 52 weeks)] An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in participants or clinical investigation participants administered an investigational (medicinal) product that does not necessarily have a causal relationship with this treatment. An SAE was defined as any event that met any of the following criteria at any dose: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received study drug; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the other serious outcomes.
- Number Of Participants With Clinically Significant Laboratory Abnormalities [From study drug dosing up to the end of the study (up to 52 weeks)] Clinically significant laboratory abnormalities were defined as Grades 3 to 4 laboratory test results according to numeric laboratory test criteria found in Common Technical Criteria for Adverse Events Version 5.0 (2017) if available; otherwise, according to Division of Acquired Immune Deficiency Syndrome. Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1 (2017) for glucose, low-density lipoprotein (LDL)-cholesterol, uric acid, and urinalysis. Laboratory test groups of clinical interest included hematology, serum chemistry, and urinalysis. Participants must have had a non-missing measurement in to be included for a given parameter. Laboratory results were presented in US units.
Eligibility Criteria
| Ages Eligible for Study | 18 Years and Older (Adult, Older Adult) |
|---|---|
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | No |
| Inclusion Criteria |
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| Exclusion Criteria |
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Contacts and Locations
| Sponsors and Collaborators | Pfizer |
|---|---|
| Locations |
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Study Documents (Full Text)
- Documents Provided by Pfizer: Study Protocol July 10, 2020
- Documents Provided by Pfizer: Statistical Analysis Plan February 7, 2022
More Information
Additional Relevant MeSH Terms
- Migraine Disorders
- Headache Disorders, Primary
- Headache Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases