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

Pfizer

Information Provided by (Responsible Party)

Pfizer

Clinicaltrials.gov Identifier

NCT04408794
Other 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
First Submitted DateMay 26, 2020
First Posted DateMay 29, 2020
Results First Submitted DateFebruary 17, 2023
Results First Posted DateMarch 16, 2023
Last Update Posted DateMay 18, 2023
Study Start DateJune 29, 2020
Actual Primary Completion DateDecember 9, 2021
Current Primary Outcome Measures
(submitted: May 16, 2023)
  1. 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.
  2. 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.
Change HistoryComplete list of historical versions of study NCT04408794 on ClinicalTrials.gov Archive Site
Current Secondary Outcome MeasuresNot Provided
Current Other Outcome MeasuresNot Provided
Descriptive Information
Brief TitleLong-term Safety Study of BHV-3500 (Zavegepant*) for the Acute Treatment of Migraine
Official TitleA Phase 2/3 Open-label, Long-Term, Safety Trial of BHV3500 (Zavegepant*) Intranasal (IN) for the Acute Treatment of Migraine
Brief SummaryThe 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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 2,Phase 3
Study DesignAllocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNot Provided
Study PopulationNot Provided
Condition
  • Acute Migraine
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:
  • Drug: Zavegepant (BHV-3500)
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
Recruitment StatusCompleted
Actual Enrollment
(submitted: May 16, 2023)
974
Actual Study Completion DateDecember 23, 2021
Actual Primary Study Completion DateDecember 9, 2021
Eligibility Criteria

Inclusion Criteria:

  • 2-8 moderate to severe migraines/month within the last 3 months
  • Migraine attacks present for more than 1 year with age of onset of migraines prior to 50 years of age
  • Migraine attacks, on average, lasting about 4-72 hours if untreated
  • Less than 15 days with headaches (migraine or non-migraine) per month in each of the 3 months prior to the screening visit
  • Ability to distinguish migraine attacks from tension/cluster headaches
  • Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria

Exclusion Criteria:

  • History of human immunodeficiency virus disease
  • History of basilar or hemiplegic migraine
  • Current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder
  • History of nasal surgery in the 6 months preceding the screening visit
  • History of gallstones or cholecystectomy
  • History of gastric, or small intestinal surgery (including gastric bypass, gastric banding, gastric sleeve, gastric balloon, etcetera), or other disease or condition (for example, chronic pancreatitis, ulcerative colitis, etcetera) that causes malabsorption.
  • Body mass index ≥ 33
  • Hemoglobin A1c ≥6.5%

Sex/GenderSexes Eligible for Study: All
Ages18 Years and Older (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesUnited 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
NCT NumberNCT04408794
Other Study ID NumbersBHV3500-202
Has Data Monitoring CommitteeNot 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 StatementNot Provided
Responsible PartyPfizer, Pfizer
Study SponsorPfizer
CollaboratorsNot Provided
InvestigatorsNot Provided
PRS AccountPfizer
Verification DateMay 2023