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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Tracking Information | |
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First Submitted Date | May 26, 2020 |
First Posted Date | May 29, 2020 |
Results First Submitted Date | February 17, 2023 |
Results First Posted Date | March 16, 2023 |
Last Update Posted Date | May 18, 2023 |
Study Start Date | June 29, 2020 |
Actual Primary Completion Date | December 9, 2021 |
Current Primary Outcome Measures(submitted: May 16, 2023) |
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Change History | Complete list of historical versions of study NCT04408794 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures | Not Provided |
Current Other Outcome Measures | Not Provided |
Descriptive Information | |
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Brief Title | Long-term Safety Study of BHV-3500 (Zavegepant*) for the Acute Treatment of Migraine |
Official Title | A Phase 2/3 Open-label, Long-Term, Safety Trial of BHV3500 (Zavegepant*) Intranasal (IN) for the Acute Treatment of Migraine |
Brief Summary | The purpose of this study is to evaluate the long-term safety of BHV-3500/vazegepant intranasal in the acute treatment of migraine. * BHV-3500, formerly "vazegepant", is now referred to as "zavegepant" (za ve' je pant). The World Health Organization (WHO) International Nonproprietary Names (INN) Expert Committee revised the name to "zavegepant" which was accepted by the United States Adopted Names (USAN ) Council for use in the U.S. and is pending formal adoption by the INN for international use. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 2,Phase 3 |
Study Design | Allocation: N/AInterventional Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment |
Target Follow-Up Duration | Not Provided |
Biospecimen | Not Provided |
Sampling Method | Not Provided |
Study Population | Not Provided |
Condition |
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Intervention | Drug: Zavegepant (BHV-3500) 10 mg IN up to 8 times per month, up to 1 year |
Study Groups/Cohorts | Experimental: Zavegepant (BHV-3500)10 mg intranasal (IN) up to 8 times per month, up to 1 year Intervention:
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Publications * | Not Provided |
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
Recruitment Information | |
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Recruitment Status | Completed |
Actual Enrollment(submitted: May 16, 2023) | 974 |
Actual Study Completion Date | December 23, 2021 |
Actual Primary Study Completion Date | December 9, 2021 |
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender | Sexes Eligible for Study: All |
Ages | 18 Years and Older (Adult, Older Adult) |
Accepts Healthy Volunteers | No |
Contacts | Contact information is only displayed when the study is recruiting subjects |
Listed Location Countries | United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States |
Administrative Information | |
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NCT Number | NCT04408794 |
Other Study ID Numbers | BHV3500-202 |
Has Data Monitoring Committee | Not Provided |
U.S FDA-regulated Product | Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: No Product Manufactured in and Exported from the U.S.: Not Provided |
IPD Sharing Statement | Not Provided |
Responsible Party | Pfizer, Pfizer |
Study Sponsor | Pfizer |
Collaborators | Not Provided |
Investigators | Not Provided |
PRS Account | Pfizer |
Verification Date | May 2023 |