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Long-term Safety Study of BHV-3500 (Zavegepant*) for the Acute Treatment of Migraine

Primary Purpose

Acute Migraine

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Zavegepant (BHV-3500)
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Migraine focused on measuring migraine, headache, intranasal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria

Exclusion Criteria:

  • History of HIV 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, etc.), or other disease or condition (e.g. chronic pancreatitis, ulcerative colitis, etc.) that causes malabsorption.
  • BMI ≥ 33
  • HbA1c ≥6.5%

Sites / Locations

  • Medical Affiliated Research Center
  • Coastal Clinical Research, LLC, An AMR Co.
  • Tucson Neuroscience Research
  • Baptist Health Center for Clinical Research
  • Pharmacology Research Institute
  • eStudySite
  • Synergy San Diego
  • Collaborative Neuroscience Network, LLC
  • Pharmacology Research Institute
  • Wr-Pri, Llc
  • Artemis Institute for Clinical Research
  • Artemis Institute for Clinical Research
  • California Medical Clinic for Headache
  • California Neuroscience Research Medical Group, Inc.
  • CT Clinical Research
  • Ki Health Partners, LLC dba New England Institute for Clinical Research
  • Clinical Neuroscience Solutions, Inc.
  • Multi-Specialty Research Associates, Inc.
  • Clinical Neuroscience Solutions, Inc.
  • Clinical Neuroscience Solutions, Inc.
  • Ormond Medical Arts Pharmaceutical Research Center
  • Meridien Research
  • iResearch Atlanta, LLC
  • Meridian Clinical Research, LLC
  • Northwest Clinical Trials Inc.
  • Community Hospital of Anderson and Madison County Inc
  • Fort Wayne Neurological Center
  • Collective Medical Research
  • Crescent City Headache and Neurology Center
  • Boston Clinical Trials
  • Community Clinical Research Network
  • Boston Neuro Research Center
  • Medvadis Research Corporation
  • Michigan Headache and Neurological Institute
  • Clinical Research Institute, Inc.
  • Sundance Clinical Research, LLC
  • StudyMetrix Research
  • Clinvest Research LLC
  • Dartmouth-Hitchcock Heater Road
  • Albuquerque Clinical Trials, Inc.
  • Montefiore Medical Center: Headache Center
  • Regional Clinical Research
  • Fieve Clinical Research, Inc
  • Rochester Clinical Research, Inc.
  • Headache Wellness Center
  • PharmQuest LLC
  • Wilmington Health, PLLC
  • OK Clinical Research LLC
  • Tekton Research, Inc.
  • Summit Research Network
  • Clinical Research of Philadelphia, LLC
  • Preferred Primary Care Physicians, Inc.
  • Preferred Primary Care Physicians, Inc.
  • Coastal Carolina Research Center
  • Volunteer Research Group
  • Clinical Neuroscience Solutions, Inc.
  • FutureSearch Trials of Neurology
  • FutureSearch Trials of Dallas, LP
  • Red Star Research LLC
  • DM Clinical Research
  • Wasatch Clinical Research, LLC
  • J. Lewis Research, Inc. / Jordan River Family Medicine
  • Charlottesville Medical Research Center, LLC
  • Tidewater Integrated Medical Research
  • Northwest Clinical Research Center
  • Seattle Women's: Health, Research, Gynecology
  • Clinical Investigation Specialist, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zavegepant (BHV-3500)

Arm Description

10 mg intranasal (IN) up to 8 times per month, up to 1 year

Outcomes

Primary Outcome Measures

Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading To Discontinuation
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
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.

Secondary Outcome Measures

Full Information

First Posted
May 26, 2020
Last Updated
May 16, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04408794
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 29, 2020 (Actual)
Primary Completion Date
December 9, 2021 (Actual)
Study Completion Date
December 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Migraine
Keywords
migraine, headache, intranasal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
974 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zavegepant (BHV-3500)
Arm Type
Experimental
Arm Description
10 mg intranasal (IN) up to 8 times per month, up to 1 year
Intervention Type
Drug
Intervention Name(s)
Zavegepant (BHV-3500)
Other Intervention Name(s)
Vazegepant
Intervention Description
10 mg IN up to 8 times per month, up to 1 year
Primary Outcome Measure Information:
Title
Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading To Discontinuation
Description
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.
Time Frame
From study drug dosing up to the end of the study (up to 52 weeks)
Title
Number Of Participants With Clinically Significant Laboratory Abnormalities
Description
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.
Time Frame
From study drug dosing up to the end of the study (up to 52 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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%
Facility Information:
Facility Name
Medical Affiliated Research Center
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Coastal Clinical Research, LLC, An AMR Co.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Tucson Neuroscience Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Baptist Health Center for Clinical Research
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Pharmacology Research Institute
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
eStudySite
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Synergy San Diego
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Facility Name
Collaborative Neuroscience Network, LLC
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Pharmacology Research Institute
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Wr-Pri, Llc
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Marcos
State/Province
California
ZIP/Postal Code
92078
Country
United States
Facility Name
California Medical Clinic for Headache
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
California Neuroscience Research Medical Group, Inc.
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
CT Clinical Research
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
Ki Health Partners, LLC dba New England Institute for Clinical Research
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Multi-Specialty Research Associates, Inc.
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
Ormond Medical Arts Pharmaceutical Research Center
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Meridien Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
iResearch Atlanta, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Northwest Clinical Trials Inc.
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Community Hospital of Anderson and Madison County Inc
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46011
Country
United States
Facility Name
Fort Wayne Neurological Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Collective Medical Research
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66208
Country
United States
Facility Name
Crescent City Headache and Neurology Center
City
Chalmette
State/Province
Louisiana
ZIP/Postal Code
70043
Country
United States
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Community Clinical Research Network
City
Marlborough
State/Province
Massachusetts
ZIP/Postal Code
01752
Country
United States
Facility Name
Boston Neuro Research Center
City
South Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Medvadis Research Corporation
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Facility Name
Michigan Headache and Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Clinical Research Institute, Inc.
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Sundance Clinical Research, LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
StudyMetrix Research
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Facility Name
Clinvest Research LLC
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65810
Country
United States
Facility Name
Dartmouth-Hitchcock Heater Road
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
Facility Name
Albuquerque Clinical Trials, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Montefiore Medical Center: Headache Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Regional Clinical Research
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Fieve Clinical Research, Inc
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Facility Name
Rochester Clinical Research, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Headache Wellness Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Facility Name
PharmQuest LLC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Wilmington Health, PLLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
OK Clinical Research LLC
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
Facility Name
Tekton Research, Inc.
City
Yukon
State/Province
Oklahoma
ZIP/Postal Code
73099
Country
United States
Facility Name
Summit Research Network
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Clinical Research of Philadelphia, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Preferred Primary Care Physicians, Inc.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
Preferred Primary Care Physicians, Inc.
City
Union
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Volunteer Research Group
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
FutureSearch Trials of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
FutureSearch Trials of Dallas, LP
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Red Star Research LLC
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
DM Clinical Research
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Wasatch Clinical Research, LLC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
J. Lewis Research, Inc. / Jordan River Family Medicine
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
Charlottesville Medical Research Center, LLC
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Tidewater Integrated Medical Research
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Seattle Women's: Health, Research, Gynecology
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Clinical Investigation Specialist, Inc.
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53144
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Long-term Safety Study of BHV-3500 (Zavegepant*) for the Acute Treatment of Migraine

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