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A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention

Primary Purpose

Migraine

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

About this trial

This is an interventional prevention trial for Migraine focused on measuring Migraine Prevention, Phonophobia, Photophobia, Nausea

Eligibility Criteria

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

Inclusion Criteria:

Subject has at least 1 year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of

Headache Disorders, 3rd Edition, including the following:

  1. Age of onset of migraines prior to 50 years of age
  2. Migraine attacks, on average, lasting 4 - 72 hours if untreated
  3. Per subject report, at least 15 headache days per month, at lest 8 migraine days per month, and at least 1 headache-free day per month within the last 3 months prior to the Screening Visit
  4. Eight or more migraine days during the Observation Period
  5. 15 or more headache days during the Observation Period
  6. One or more non-headache days during the Observation Period
  7. Ability to distinguish migraine attacks from tension/cluster headaches
  8. Subjects on prophylactic migraine medication are permitted to remain on 1 medication with possible migraine-prophylactic effects if the dose has been stable for at least 3 months prior to the Screening Visit, and the dose is not expected to change during the course of the study.

Exclusion Criteria:

  1. Subject with a history of HIV disease
  2. Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening
  3. Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to screening).
  4. Subjects with major depressive episode or anxiety disorder which require more than 1 daily medication for each disorder or subjects with a major depressive episode within the last 12 months. Medications to treat major depressive disorder or an anxiety disorder must have been at a stable dose for at least 3 months prior to the Screening Visit.
  5. Subjects with active chronic pain syndromes, other pain syndromes (including trigeminal neuralgia), psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion interfere with study assessments of safety or efficacy.
  6. Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease or condition (e.g. chronic pancreatitis, ulcerative colitis, etc.) that causes malabsorption.
  7. Body mass index > 33 kg/m2
  8. History of gallstones or cholecystectomy.
  9. The subject has a history or current evidence of any unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known or suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial

Sites / Locations

  • Xenoscience, IncRecruiting
  • Tucson Neuroscience ResearchRecruiting
  • Hope Clinical ResearchRecruiting
  • Axiom Research, LlcRecruiting
  • Wr-Pri, LlcRecruiting
  • eStudySiteRecruiting
  • Synergy San DiegoRecruiting
  • Collaborative Neuroscience Research, LLC.Recruiting
  • Clinical Research InstituteRecruiting
  • Wr-Pri, LlcRecruiting
  • Artemis Institute for Clinical ResearchRecruiting
  • California Neuroscience Research Medical Group, inc.Recruiting
  • CMR of Greater New Haven, LLCRecruiting
  • Ki Health Partners, LLc, dba New England Institute for Clinical ResearchRecruiting
  • Chase Medical Research, LLCRecruiting
  • Neurology Offices of South FloridaRecruiting
  • Complete Health ResearchRecruiting
  • Sarkis Clinical TrialsRecruiting
  • Clinical Neuroscience Solutions, Inc.Recruiting
  • Multi-Specialty Research Associates, Inc.Recruiting
  • AppleMed Research Group, LLCRecruiting
  • AppleMed Research Group, LLCRecruiting
  • Brainstorm ResearchRecruiting
  • The Neurology Research GroupRecruiting
  • Clinical Neuroscience Solutions, Inc.Recruiting
  • Complete Health ResearchRecruiting
  • Ideal Clinical ResearchRecruiting
  • Clinical Research Center of FloridaRecruiting
  • Accel Research Sites Network - St. Petersburg Clinical Research Unit
  • Clin-Med Research & Development LLCRecruiting
  • ForCare Clinical ResearchRecruiting
  • JSV Clinical Research Study IncRecruiting
  • CenExel iResearch, LLCRecruiting
  • iResearch Atlanta LLCRecruiting
  • Cedar Crosse Research CenterRecruiting
  • Clinical Investigation Specialists, Inc.Recruiting
  • Clinical Investigation Specialists, IncRecruiting
  • MediSphere Medical Research Center, LLC.Recruiting
  • MediSphere Medical Research Center, LLCRecruiting
  • Meridian Clinical Research, LLCRecruiting
  • Alliance for Multispecialty Reseach, LLC
  • Alliance for Multispecialty Research, LLC
  • Collevtive Medical ResearchRecruiting
  • Kansas Institute of ResearchRecruiting
  • The Research Group of Lexington, Llc.Recruiting
  • The Research Group of Lexington, LlcRecruiting
  • L-MARC Research Center
  • Crescent City Headache and Neurology CenterRecruiting
  • Alliance for Multispecialty Research, LLC.
  • DelRicht ResearchRecruiting
  • Boston Clinical TrialsRecruiting
  • Neurology Center of New England P.C.
  • Community Clinical Research Network IncRecruiting
  • MedVadis Research CorporationRecruiting
  • Michigan Head Pain & Neurological InstituteRecruiting
  • Romedica LLC
  • Alliance for Multispecialty Reseach, LLCRecruiting
  • StudyMetrix ResearchRecruiting
  • Clinvest Research, LLCRecruiting
  • Clinvest Research, LLCRecruiting
  • Meridian Clinical Research, LLCRecruiting
  • Excel Clinical researchRecruiting
  • Wr-Crcn, LlcRecruiting
  • Albuquerque Clinical Trials, Inc.Recruiting
  • Dent Neurosciences Research Center, Inc.Recruiting
  • Montefiore Medical Center
  • Central New York Clinical Research
  • New York Neurology AssociatesRecruiting
  • Fieve Clinical Research, IncRecruiting
  • North Suffolk Neurology, PCRecruiting
  • Upstate Clinical Research Associates, LLCRecruiting
  • Headache Wellness CenterRecruiting
  • AccellacareRecruiting
  • M3 Wake Research, Inc.Recruiting
  • Carolina Research Center, Inc.Recruiting
  • AccellacareRecruiting
  • CTI Clinical Research CenterRecruiting
  • Wellnow Urgent CareRecruiting
  • Hometown Urgent Care and ResearchRecruiting
  • Wellnow Urgent Care and ResearchRecruiting
  • Hometown Urgent Care and ResearchRecruiting
  • WellNow Urgent Care and ResearchRecruiting
  • Neuro-Behavioral Clinical Research, Inc.Recruiting
  • WellNow Urgent Care and ResearchRecruiting
  • Hightower ClinicalRecruiting
  • Summit Headlands LLC, dba Summit ResearchRecruiting
  • Clinical Research Philadelphia, LLCRecruiting
  • Preferred Primary Care Physicians, Inc.Recruiting
  • Preferred Primary Care PhysiciansRecruiting
  • Reading Hospital Clinical Trials OfficeRecruiting
  • Tower Health Medical Group - NeurologyRecruiting
  • Coastal Carolina Research CenterRecruiting
  • Accellacare (Administrative Only)Recruiting
  • Internal Medicine and Pediatric Associates of Bristol, PCRecruiting
  • WR-ClinSearch, LLCRecruiting
  • KCA Neurology, PLLCRecruiting
  • Clinical Neuroscience Solutions, Inc.Recruiting
  • FutureSearch Trials of NeurologyRecruiting
  • FutureSearch Trials of Dallas, LPRecruiting
  • North Texas Institute of Neurology and HeadacheRecruiting
  • Texas Center for Drug Development, Inc.Recruiting
  • Red Star Research. LLCRecruiting
  • FMC ScienceRecruiting
  • DM Clinical ResearchRecruiting
  • Wasatch Clinical Research , LLC(Administrative Location)Recruiting
  • Charlottesville Medical Research Center, LLCRecruiting
  • Health Research of Hampton Roads, Inc.Recruiting
  • Meridian Clinical Research, LLC
  • Northwest Clinical Research CenterRecruiting
  • Seattle Clinical Research CenterRecruiting
  • Seattle Women's: Health, Research, GynecologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

BHV-3500 200mg

Placebo 200mg

BHV-3500 100mg

Placebo 100mg

Arm Description

Zavegepant 200mg oral soft gel capsule.

Matching placebo 200mg oral soft gel capsule.

Zavegepant 100mg oral soft gel capsule.

Matching placebo 100mg oral soft gel capsule.

Outcomes

Primary Outcome Measures

Efficacy of zavegepant compared to placebo as a preventive treatment for migraine
Measured by the mean reduction from baseline (i.e., Observation Phase) in the number of migraine days per month over the entire Double-blind Treatment Phase.

Secondary Outcome Measures

Efficacy of zavegepant compared to placebo with the number of subjects that had a ≥ 50% reduction from Observational Phase.
Measured by the number of moderate to severe migraine days per month over the entire double-blind treatment phase.
Efficacy of zavegepant to placebo on mean reduction from Observational Phase.
Measured by the number of migraine days in the last 4 weeks of the Double-Blind Treatment Phase.
Efficacy of zavegepant to placebo on mean reduction from Observational Phase.
Measured by the number of migraine days per month in the first 4 weeks of the Double-Blind Treatment Phase.
Efficacy of zavegepant to placebo in the mean number of acute migraine specific medication days per month.
Measured by the number of acute migraine specific medication days over the entire Double-Blind Treatment Phase.
Mean Change From Baseline in the Migraine Specific Quality of Life (MSQoL) Role Function-Restrictive Domain Score at Week 12 of the DBT Phase.
The change from baseline is calculated as the MSQoL restrictive role function domain score at Week 12 of the DBT phase minus the MSQoL restrictive role function domain score at baseline.
Mean Change From Baseline in the Migraine Disability Assessment (MIDAS) Total Score at Week 12 of the DBT Phase.
The change from baseline is calculated as the MIDAS total score at Week 12 of the DBT phase minus the MIDAS total score at baseline.
Evaluate the safety and tolerability of zavegepant.
This will be evaluated by the number of participants with treatment related adverse events by severity measured as mild, moderate, or severe.
The frequency of ALT or AST elevations > 3x ULN, concurrently with bilirubin elevations > 2x ULN in subjects treated with zavegepent during the double-blind and open label phases.
The frequency of hepatic related adverse events.
Measured by discontinuations in subjects treated with zavegepant due to elevated Liver Function Tests during the double-blind and open label phases

Full Information

First Posted
March 5, 2021
Last Updated
September 5, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04804033
Brief Title
A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention
Official Title
A Phase 2/3 Randomized, Double-Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 26, 2021 (Actual)
Primary Completion Date
December 28, 2027 (Anticipated)
Study Completion Date
December 27, 2028 (Anticipated)

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 is study is to compare the efficacy of BHV-3500 (zavegepant) to placebo as a preventive treatment for migraine, as measured by the reduction in the number of migraine days per month.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine Prevention, Phonophobia, Photophobia, Nausea

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BHV-3500 200mg
Arm Type
Active Comparator
Arm Description
Zavegepant 200mg oral soft gel capsule.
Arm Title
Placebo 200mg
Arm Type
Placebo Comparator
Arm Description
Matching placebo 200mg oral soft gel capsule.
Arm Title
BHV-3500 100mg
Arm Type
Active Comparator
Arm Description
Zavegepant 100mg oral soft gel capsule.
Arm Title
Placebo 100mg
Arm Type
Placebo Comparator
Arm Description
Matching placebo 100mg oral soft gel capsule.
Intervention Type
Drug
Intervention Name(s)
BHV-3500 (zavegepant)
Intervention Description
BHV-3500 (zavegepant) softgel capsule.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo softgel capsule.
Primary Outcome Measure Information:
Title
Efficacy of zavegepant compared to placebo as a preventive treatment for migraine
Description
Measured by the mean reduction from baseline (i.e., Observation Phase) in the number of migraine days per month over the entire Double-blind Treatment Phase.
Time Frame
Number of migraine during weeks 1 to 12
Secondary Outcome Measure Information:
Title
Efficacy of zavegepant compared to placebo with the number of subjects that had a ≥ 50% reduction from Observational Phase.
Description
Measured by the number of moderate to severe migraine days per month over the entire double-blind treatment phase.
Time Frame
Number of migraine days during weeks 1 to 12
Title
Efficacy of zavegepant to placebo on mean reduction from Observational Phase.
Description
Measured by the number of migraine days in the last 4 weeks of the Double-Blind Treatment Phase.
Time Frame
Number of migraine days during per month during weeks 9 to 12
Title
Efficacy of zavegepant to placebo on mean reduction from Observational Phase.
Description
Measured by the number of migraine days per month in the first 4 weeks of the Double-Blind Treatment Phase.
Time Frame
Number of migraine days per month during weeks 1 to 4
Title
Efficacy of zavegepant to placebo in the mean number of acute migraine specific medication days per month.
Description
Measured by the number of acute migraine specific medication days over the entire Double-Blind Treatment Phase.
Time Frame
Number of migraine days per month during weeks 1 to 12
Title
Mean Change From Baseline in the Migraine Specific Quality of Life (MSQoL) Role Function-Restrictive Domain Score at Week 12 of the DBT Phase.
Description
The change from baseline is calculated as the MSQoL restrictive role function domain score at Week 12 of the DBT phase minus the MSQoL restrictive role function domain score at baseline.
Time Frame
Week 12 of the double-blind treatment phase.
Title
Mean Change From Baseline in the Migraine Disability Assessment (MIDAS) Total Score at Week 12 of the DBT Phase.
Description
The change from baseline is calculated as the MIDAS total score at Week 12 of the DBT phase minus the MIDAS total score at baseline.
Time Frame
Week 12 of the double-blind treatment phase.
Title
Evaluate the safety and tolerability of zavegepant.
Description
This will be evaluated by the number of participants with treatment related adverse events by severity measured as mild, moderate, or severe.
Time Frame
From Baseline through Week 12
Title
The frequency of ALT or AST elevations > 3x ULN, concurrently with bilirubin elevations > 2x ULN in subjects treated with zavegepent during the double-blind and open label phases.
Time Frame
From Baseline through Week 12
Title
The frequency of hepatic related adverse events.
Description
Measured by discontinuations in subjects treated with zavegepant due to elevated Liver Function Tests during the double-blind and open label phases
Time Frame
From Baseline through Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has at least 1 year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following: Age of onset of migraines prior to 50 years of age Migraine attacks, on average, lasting 4 - 72 hours if untreated Per subject report, at least 15 headache days per month, at lest 8 migraine days per month, and at least 1 headache-free day per month within the last 3 months prior to the Screening Visit Eight or more migraine days during the Observation Period 15 or more headache days during the Observation Period One or more non-headache days during the Observation Period Ability to distinguish migraine attacks from tension/cluster headaches Subjects on prophylactic migraine medication are permitted to remain on 1 medication with possible migraine-prophylactic effects if the dose has been stable for at least 3 months prior to the Screening Visit, and the dose is not expected to change during the course of the study. Exclusion Criteria: Subject with a history of HIV disease Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to screening). Subjects with major depressive episode or anxiety disorder which require more than 1 daily medication for each disorder or subjects with a major depressive episode within the last 12 months. Medications to treat major depressive disorder or an anxiety disorder must have been at a stable dose for at least 3 months prior to the Screening Visit. Subjects with active chronic pain syndromes, other pain syndromes (including trigeminal neuralgia), psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion interfere with study assessments of safety or efficacy. Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease or condition (e.g. chronic pancreatitis, ulcerative colitis, etc.) that causes malabsorption. Body mass index > 33 kg/m2 History of gallstones or cholecystectomy. The subject has a history or current evidence of any unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known or suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Xenoscience, Inc
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Individual Site Status
Recruiting
Facility Name
Tucson Neuroscience Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Individual Site Status
Recruiting
Facility Name
Hope Clinical Research
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Individual Site Status
Recruiting
Facility Name
Axiom Research, Llc
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
Individual Site Status
Recruiting
Facility Name
Wr-Pri, Llc
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Individual Site Status
Recruiting
Facility Name
eStudySite
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Individual Site Status
Recruiting
Facility Name
Synergy San Diego
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Individual Site Status
Recruiting
Facility Name
Collaborative Neuroscience Research, LLC.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Name
Wr-Pri, Llc
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Individual Site Status
Recruiting
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Name
California Neuroscience Research Medical Group, inc.
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Individual Site Status
Recruiting
Facility Name
CMR of Greater New Haven, LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06517
Country
United States
Individual Site Status
Recruiting
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
Individual Site Status
Recruiting
Facility Name
Chase Medical Research, LLC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurology Offices of South Florida
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Individual Site Status
Recruiting
Facility Name
Complete Health Research
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Name
Multi-Specialty Research Associates, Inc.
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Individual Site Status
Recruiting
Facility Name
AppleMed Research Group, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Name
AppleMed Research Group, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
Brainstorm Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Name
The Neurology Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Individual Site Status
Recruiting
Facility Name
Complete Health Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Individual Site Status
Recruiting
Facility Name
Ideal Clinical Research
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Center of Florida
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Individual Site Status
Recruiting
Facility Name
Accel Research Sites Network - St. Petersburg Clinical Research Unit
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clin-Med Research & Development LLC
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Individual Site Status
Recruiting
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Name
JSV Clinical Research Study Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Individual Site Status
Recruiting
Facility Name
CenExel iResearch, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Recruiting
Facility Name
iResearch Atlanta LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Recruiting
Facility Name
Cedar Crosse Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Investigation Specialists, Inc.
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Investigation Specialists, Inc
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Individual Site Status
Recruiting
Facility Name
MediSphere Medical Research Center, LLC.
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Individual Site Status
Recruiting
Facility Name
MediSphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research, LLC
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51106
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance for Multispecialty Reseach, LLC
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Individual Site Status
Terminated
Facility Name
Alliance for Multispecialty Research, LLC
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Individual Site Status
Terminated
Facility Name
Collevtive Medical Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Individual Site Status
Recruiting
Facility Name
Kansas Institute of Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Individual Site Status
Recruiting
Facility Name
The Research Group of Lexington, Llc.
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Individual Site Status
Recruiting
Facility Name
The Research Group of Lexington, Llc
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Individual Site Status
Recruiting
Facility Name
L-MARC Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Individual Site Status
Terminated
Facility Name
Crescent City Headache and Neurology Center
City
Chalmette
State/Province
Louisiana
ZIP/Postal Code
70043
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance for Multispecialty Research, LLC.
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
DelRicht Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70124
Country
United States
Individual Site Status
Recruiting
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurology Center of New England P.C.
City
Foxboro
State/Province
Massachusetts
ZIP/Postal Code
02035
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Community Clinical Research Network Inc
City
Marlborough
State/Province
Massachusetts
ZIP/Postal Code
01752
Country
United States
Individual Site Status
Recruiting
Facility Name
MedVadis Research Corporation
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Individual Site Status
Recruiting
Facility Name
Michigan Head Pain & Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Individual Site Status
Recruiting
Facility Name
Romedica LLC
City
Rochester
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Individual Site Status
Terminated
Facility Name
Alliance for Multispecialty Reseach, LLC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Individual Site Status
Recruiting
Facility Name
StudyMetrix Research
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinvest Research, LLC
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinvest Research, LLC
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65810
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research, LLC
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Individual Site Status
Recruiting
Facility Name
Excel Clinical research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Individual Site Status
Recruiting
Facility Name
Wr-Crcn, Llc
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89118
Country
United States
Individual Site Status
Recruiting
Facility Name
Albuquerque Clinical Trials, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Individual Site Status
Recruiting
Facility Name
Dent Neurosciences Research Center, Inc.
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Individual Site Status
Recruiting
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Central New York Clinical Research
City
Manlius
State/Province
New York
ZIP/Postal Code
13104
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
New York Neurology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
Facility Name
Fieve Clinical Research, Inc
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Individual Site Status
Recruiting
Facility Name
North Suffolk Neurology, PC
City
Port Jefferson Station
State/Province
New York
ZIP/Postal Code
11776
Country
United States
Individual Site Status
Recruiting
Facility Name
Upstate Clinical Research Associates, LLC
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Individual Site Status
Recruiting
Facility Name
Headache Wellness Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Individual Site Status
Recruiting
Facility Name
Accellacare
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Individual Site Status
Recruiting
Facility Name
M3 Wake Research, Inc.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Individual Site Status
Recruiting
Facility Name
Carolina Research Center, Inc.
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Individual Site Status
Recruiting
Facility Name
Accellacare
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Individual Site Status
Recruiting
Facility Name
CTI Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Individual Site Status
Recruiting
Facility Name
Wellnow Urgent Care
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215
Country
United States
Individual Site Status
Recruiting
Facility Name
Hometown Urgent Care and Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Name
Wellnow Urgent Care and Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Name
Hometown Urgent Care and Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
Individual Site Status
Recruiting
Facility Name
WellNow Urgent Care and Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
Individual Site Status
Recruiting
Facility Name
Neuro-Behavioral Clinical Research, Inc.
City
North Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States
Individual Site Status
Recruiting
Facility Name
WellNow Urgent Care and Research
City
Troy
State/Province
Ohio
ZIP/Postal Code
45373
Country
United States
Individual Site Status
Recruiting
Facility Name
Hightower Clinical
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73134
Country
United States
Individual Site Status
Recruiting
Facility Name
Summit Headlands LLC, dba Summit Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Philadelphia, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Individual Site Status
Recruiting
Facility Name
Preferred Primary Care Physicians, Inc.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Individual Site Status
Recruiting
Facility Name
Preferred Primary Care Physicians
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Individual Site Status
Recruiting
Facility Name
Reading Hospital Clinical Trials Office
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Individual Site Status
Recruiting
Facility Name
Tower Health Medical Group - Neurology
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Individual Site Status
Recruiting
Facility Name
Coastal Carolina Research Center
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Individual Site Status
Recruiting
Facility Name
Accellacare (Administrative Only)
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Individual Site Status
Recruiting
Facility Name
Internal Medicine and Pediatric Associates of Bristol, PC
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Individual Site Status
Recruiting
Facility Name
WR-ClinSearch, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Individual Site Status
Recruiting
Facility Name
KCA Neurology, PLLC
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Recruiting
Facility Name
FutureSearch Trials of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Recruiting
Facility Name
FutureSearch Trials of Dallas, LP
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Name
North Texas Institute of Neurology and Headache
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Center for Drug Development, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Individual Site Status
Recruiting
Facility Name
Red Star Research. LLC
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Individual Site Status
Recruiting
Facility Name
FMC Science
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550
Country
United States
Individual Site Status
Recruiting
Facility Name
DM Clinical Research
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Individual Site Status
Recruiting
Facility Name
Wasatch Clinical Research , LLC(Administrative Location)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Name
Charlottesville Medical Research Center, LLC
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Individual Site Status
Recruiting
Facility Name
Health Research of Hampton Roads, Inc.
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research, LLC
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Terminated
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Individual Site Status
Recruiting
Facility Name
Seattle Clinical Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Name
Seattle Women's: Health, Research, Gynecology
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=BHV3500-302
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention

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