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Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens

Primary Purpose

Migraine

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Rimegepant 75mg daily dosing
Rimegepant 75mg every other day dosing
Placebo comparator dosing
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine, Episodic Migraine, Adult Migraine, Calcitonin Gene-related Peptide, Migraine Prevention, Migraine Prophylaxis

Eligibility Criteria

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

Inclusion Criteria:

1) Target Population: Subject has at least 1 year history of episodic 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, 4-14 migraine attacks per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol

Exclusion Criteria:

  1. Sex and Reproductive Status:

    1. WOCBP who are unwilling or unable to use an acceptable contraceptive method or abstinence to avoid pregnancy for the entire study and for 60 days after the last dose of study drug
    2. Women who are pregnant or breastfeeding
    3. Women with a positive pregnancy test at screening or prior to study drug administration

  2. Prohibited Medications:

    1. Use of prophylactic migraine medication within 30 days prior to the Screening Visit.
    2. History of use of analgesics (e.g., non-steroidal anti-inflammatory drugs [NSAIDs] or acetaminophen) on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.
    3. Use of medication accepted for treatment of acute migraine for a nonmigraine indication on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.
    4. Subjects who previously discontinued biologic migraine medication must have done so at least 3 months (12 weeks) prior to the Screening Visit.
    5. Subjects taking a prohibited medication as defined per protocol

Sites / Locations

  • Alliance for Multispecialty Research, LLCRecruiting
  • Axiom Research, LlcRecruiting
  • Clinical Research InstituteRecruiting
  • Wr-Pri, LlcRecruiting
  • California Neuroscience Research Medical Group, inc.Recruiting
  • Neurology Offices of South Florida, PLLCRecruiting
  • AppleMed Research Group, LLCRecruiting
  • Clinical Investigation Specialists, Inc.Recruiting
  • MediSphere Medical Research Center, LLCRecruiting
  • Collective Medical ResearchRecruiting
  • Collective Medical ResearchRecruiting
  • Clinvest Research, LLCRecruiting
  • Alliance for Multispecialty Research, LLCRecruiting
  • Dent Neurosciences Research Center, Inc.Recruiting
  • Montefiore Medical CenterRecruiting
  • Upstate Clinical Research Associates, LLCRecruiting
  • Wellnow Urgent Care and ResearchRecruiting
  • Wellnow Urgent Care and ResearchRecruiting
  • WellNow Urgent Care and ResearchRecruiting
  • WellNow Urgent Care and ResearchRecruiting
  • Wellnow Urgent Care and ResearchRecruiting
  • Velocity Clinical Research, MedfordRecruiting
  • Preferred Primary Care Physicians, Inc.Recruiting
  • Velocity Clinical Research - ProvidenceRecruiting
  • Velocity Clinical Research - ColumbiaRecruiting
  • Velocity Clinical Research, GaffneyRecruiting
  • Tribe Clinical Research LLCRecruiting
  • Clinical Research Associates, Inc.Recruiting
  • FutureSearch Trials of NeurologyRecruiting
  • FutureSearch Trials of Dallas, LPRecruiting
  • Texas Center for Drug Development, Inc.Recruiting
  • APD Clinical ResearchRecruiting
  • Wasatch Clinical Research , LLC(Administrative Location)Recruiting
  • Seattle Clinical Research CenterRecruiting
  • Medizinische Universitat InnsbruckRecruiting
  • Christian-Doppler-KlinikRecruiting
  • Paracelsus Medizinischen Privatuniversitaet - Christian-Doppler-Klinik (CDK)
  • Calgary Headache & Assessment Management Program (CHAMP)
  • OCT Research ULCRecruiting
  • James K. Lai MD Inc.Recruiting
  • Centricity ResearchRecruiting
  • True North Clinical Research Inc.Recruiting
  • Aggarwal and Associates LimitedRecruiting
  • Manna Research Inc. (Burlington North)Recruiting
  • Milestone Research Inc.Recruiting
  • Bluewater Clinical Research Group Inc.Recruiting
  • Mirtorabi Medicine Professional CorporationRecruiting
  • Toronto Memory ProgramRecruiting
  • Manna Research (Toronto)Recruiting
  • Diex Recherche Sherbrooke Inc.Recruiting
  • Hopital Gabriel MontpiedRecruiting
  • Hopital Roger Salengro CHU LilleRecruiting
  • Hopital de La TimoneRecruiting
  • Centre Hospitalier Annecy GenevoisRecruiting
  • Klinische Forschung Karlsruhe GmbHRecruiting
  • Vitos Orthopaedische Klinik KasselRecruiting
  • Arztepartnerschaft Dr. med. J. Springub/ W. Schwarz -Studienzentrum Nord-WestRecruiting
  • Siteworks - Zentrum fur klinische Studien HannoverRecruiting
  • Klinische Forschung Schwerin GmbHRecruiting
  • Universitatsklinikum Jena
  • Klinische Forschung Berlin-Mitte
  • Neurologisches Facharztzentrum Berlin (NFZB) - Sankt Gertrauden-Krankenhaus Location
  • Studienzentrum Dr. A Schwittay
  • Klinische Forschung Dresden GmbH
  • Universitaetsklinikum Essen - Klinik und Poliklinik fuer Neurologie - Schwindel-Zentrum Essen
  • Kopfschmerzzentrum FrankfurtRecruiting
  • Klinische Forschung Hamburg GmbHRecruiting
  • Zentrum für klinische Studien HannoverRecruiting
  • Klinische Forschung Karlsruhe GmbHRecruiting
  • Neurologisch-verhaltensmedizinische Schmerzklinik Kiel
  • Datamed GmbHRecruiting
  • NeuroMed Campus - Neurologische Gemeinschaftspraxis am St. Elisabeth KrankenhausRecruiting
  • Ludwig-Maximilians-Universitaet Muenchen Klinikum der Universitaet Muenchen - Campus Grosshadern
  • Klinische Forschung Schwerin GmbHRecruiting
  • Fachuebergreifende Gemeinschaftspraxis Dr.Med. Joachim Springub & Wolfgang SchwarzRecruiting
  • AOU Careggi - Centro CefaleeRecruiting
  • Fondazione Mondino - Istituto Neurologico Nazionale IRCCS
  • Azienda Ospedaliera San Giuseppe Moscati-Unita di Neurologia
  • IRCCS Istituto delle Scienze Neurologiche Bologna
  • ASST Spedali Civili di Brescia, U.O. Neurologia
  • Neurorehabilitation Unit-ICOT Istituto Marco Pasquali
  • IRCCS San Raffaele Roma
  • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-DworakRecruiting
  • Centrum Medyczne Pratia BydgoszczRecruiting
  • Indywidualna Praktyka Lekarska Dr Hab. Med. Anna Szczepanska-SzerejRecruiting
  • Krakowska Akademia Neurologii Sp. Z o.o.Recruiting
  • Krakowska Akademia Neurologil Sp. Z o.o.Recruiting
  • Next Stage Sp. Z o.o.Recruiting
  • Wojskowy Instytut MedycznyRecruiting
  • Pratia MCM KrakowRecruiting
  • Centrum Medyczne Pratia CzestochowaRecruiting
  • Centrum Medyczne Pratia KatowiceRecruiting
  • NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSISRecruiting
  • Solumed Centrum MedyczneRecruiting
  • NZOZ Neuromed M. i M. Nastaj Sp. P.Recruiting
  • MTZ Clinical Research Powered by Pratia
  • Hospital Clinico Universitario de Valladolid • HCUVRecruiting
  • Hospital Alvaro Cunqueiro
  • Instituto de Investigaciones del Sueno
  • Hospital Universitario La PazRecruiting
  • Virgen del Rocio HospitalRecruiting
  • Ladulaas Clinical TrialsRecruiting
  • PharmasiteRecruiting
  • CTC Clinical Trial Consultants AB
  • ProbarE i LundRecruiting
  • PharmasiteRecruiting
  • Studieenheten Akademiskt Specialistcentrum SLSO
  • Royal Primary Care Ashgate, Chesterfield Royal Hospital, NHS Foundation TrustRecruiting
  • Panthera BiopartnersRecruiting
  • Re:Cognition Health - WinchesterRecruiting
  • Intelligent ClinicalRecruiting
  • Panthera Bio PartnersRecruiting
  • Re:Cognition Health - LondonRecruiting
  • Re:Cognition Health-Private PracticeRecruiting
  • CPS ResearchRecruiting
  • Re-Cognition Health - BristolRecruiting
  • Panthera Biopartners - SheffieldRecruiting
  • Re-Cognition HealthRecruiting
  • Re-Cognition HealthRecruiting
  • Panthera Biopartners GlasgowRecruiting
  • Panthera Biopartners - EnfieldRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Rimegepant 75mg Orally Disitegrating Tablet (ODT)daily dosing

Rimegepant 75mg Orally Disintegrating Tablet (ODT)every other day dosing

Placebo comparator dosing

Arm Description

Double-blind Treatment Phase: Rimegepant 75 mg ODT dosed daily Open-Label Extension Phase: Rimegepant 75 mg ODT dosed daily

Double-blind Treatment Phase: Rimegepant 75 mg ODT every other day dosing alternating with matching placebo

Double-blind Treatment Phase: matching placebo dosed daily

Outcomes

Primary Outcome Measures

Mean change from the Observation Phase in the number of migraine days per month over the entire Double-blind Treatment Phase (Weeks 1-12)
Change from baseline in mean number of migraine days per month

Secondary Outcome Measures

Proportion of subjects with > 50% reduction from the Observation Phase (Weeks 1 to 12).
Number of moderate to severe migraine days per month over the entire Double-blind Treatment Phase
Mean change from the Observation Phase.
Number of migraine days per month in the last 4 weeks of the Double-blind Treatment Phase.
Mean change from the Observation Phase
number of migraine days per month in the first 4 weeks of the Double-blind Treatment Phase.
Mean number of acute migraine-specific medication days per month.
Over the entire Double-blind Treatment Phase. Acute migraine-specific medications are triptans and ergotamine.
Mean change from baseline in the Migraine-Specific Quality-of-Life Questionnaire (MSQ) restrictive role function.
Domain score of the Double-blind Treatment Phase.
Number and percentage of subjects with AEs by intensity.
Serious adverse events (SAEs), AEs leading to study drug discontinuation, and grade 3 to 4 laboratory test abnormalities during the Double-blind Treatment and Open-label Extension Phases.
Number and percentage of subjects treated with rimegepant with AST or ALT elevations.
>3x ULN concurrent (i.e., on the same laboratory collection date) with total bilirubin > 2x ULN during the Double-blind Treatment and Open-label Extension Phases.
Number and percentage of subjects treated with rimegepant with hepatic-related AEs
By intensity and hepatic-related AEs leading to study drug discontinuation during the Double-blind Treatment and Open-label Extension Phases.

Full Information

First Posted
January 20, 2022
Last Updated
September 26, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05217927
Brief Title
Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens
Official Title
A Phase 4 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 4, 2022 (Actual)
Primary Completion Date
September 21, 2024 (Anticipated)
Study Completion Date
February 8, 2025 (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 study is to compare the efficacy and safety of daily and every other day dosing of rimegepant to placebo as a preventive treatment for episodic migraine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, Episodic Migraine, Adult Migraine, Calcitonin Gene-related Peptide, Migraine Prevention, Migraine Prophylaxis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
660 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rimegepant 75mg Orally Disitegrating Tablet (ODT)daily dosing
Arm Type
Experimental
Arm Description
Double-blind Treatment Phase: Rimegepant 75 mg ODT dosed daily Open-Label Extension Phase: Rimegepant 75 mg ODT dosed daily
Arm Title
Rimegepant 75mg Orally Disintegrating Tablet (ODT)every other day dosing
Arm Type
Experimental
Arm Description
Double-blind Treatment Phase: Rimegepant 75 mg ODT every other day dosing alternating with matching placebo
Arm Title
Placebo comparator dosing
Arm Type
Placebo Comparator
Arm Description
Double-blind Treatment Phase: matching placebo dosed daily
Intervention Type
Drug
Intervention Name(s)
Rimegepant 75mg daily dosing
Intervention Description
Daily
Intervention Type
Drug
Intervention Name(s)
Rimegepant 75mg every other day dosing
Intervention Description
Every other day
Intervention Type
Drug
Intervention Name(s)
Placebo comparator dosing
Intervention Description
Placebo comparator
Primary Outcome Measure Information:
Title
Mean change from the Observation Phase in the number of migraine days per month over the entire Double-blind Treatment Phase (Weeks 1-12)
Description
Change from baseline in mean number of migraine days per month
Time Frame
3 months (12 weeks)
Secondary Outcome Measure Information:
Title
Proportion of subjects with > 50% reduction from the Observation Phase (Weeks 1 to 12).
Description
Number of moderate to severe migraine days per month over the entire Double-blind Treatment Phase
Time Frame
3 months (12 weeks)
Title
Mean change from the Observation Phase.
Description
Number of migraine days per month in the last 4 weeks of the Double-blind Treatment Phase.
Time Frame
Weeks 9 to 12
Title
Mean change from the Observation Phase
Description
number of migraine days per month in the first 4 weeks of the Double-blind Treatment Phase.
Time Frame
Weeks 1 to 4
Title
Mean number of acute migraine-specific medication days per month.
Description
Over the entire Double-blind Treatment Phase. Acute migraine-specific medications are triptans and ergotamine.
Time Frame
Weeks 1 to 12
Title
Mean change from baseline in the Migraine-Specific Quality-of-Life Questionnaire (MSQ) restrictive role function.
Description
Domain score of the Double-blind Treatment Phase.
Time Frame
At Week 12
Title
Number and percentage of subjects with AEs by intensity.
Description
Serious adverse events (SAEs), AEs leading to study drug discontinuation, and grade 3 to 4 laboratory test abnormalities during the Double-blind Treatment and Open-label Extension Phases.
Time Frame
24 Weeks
Title
Number and percentage of subjects treated with rimegepant with AST or ALT elevations.
Description
>3x ULN concurrent (i.e., on the same laboratory collection date) with total bilirubin > 2x ULN during the Double-blind Treatment and Open-label Extension Phases.
Time Frame
24 Weeks
Title
Number and percentage of subjects treated with rimegepant with hepatic-related AEs
Description
By intensity and hepatic-related AEs leading to study drug discontinuation during the Double-blind Treatment and Open-label Extension Phases.
Time Frame
24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1) Target Population: Subject has at least 1 year history of episodic 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, 4-14 migraine attacks per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol Exclusion Criteria: Sex and Reproductive Status: WOCBP who are unwilling or unable to use an acceptable contraceptive method or abstinence to avoid pregnancy for the entire study and for 60 days after the last dose of study drug Women who are pregnant or breastfeeding Women with a positive pregnancy test at screening or prior to study drug administration Prohibited Medications: Use of prophylactic migraine medication within 30 days prior to the Screening Visit. History of use of analgesics (e.g., non-steroidal anti-inflammatory drugs [NSAIDs] or acetaminophen) on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit. Use of medication accepted for treatment of acute migraine for a nonmigraine indication on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit. Subjects who previously discontinued biologic migraine medication must have done so at least 6 months (24 weeks) prior to the Screening Visit. Subjects taking a prohibited medication as defined per protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer 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
Alliance for Multispecialty Research, LLC
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281
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
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
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
Neurology Offices of South Florida, PLLC
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
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
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
Collective Medical Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Individual Site Status
Recruiting
Facility Name
Collective Medical Research
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66208
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
Alliance for Multispecialty Research, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
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
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
Wellnow 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
43228
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
WellNow Urgent Care and Research
City
Huber Heights
State/Province
Ohio
ZIP/Postal Code
45424
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
Velocity Clinical Research, Medford
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
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
Velocity Clinical Research - Providence
City
East Greenwich
State/Province
Rhode Island
ZIP/Postal Code
02818
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research - Columbia
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research, Gaffney
City
Gaffney
State/Province
South Carolina
ZIP/Postal Code
29340
Country
United States
Individual Site Status
Recruiting
Facility Name
Tribe Clinical Research LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Associates, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
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
Texas Center for Drug Development, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Individual Site Status
Recruiting
Facility Name
APD Clinical Research
City
Magnolia
State/Province
Texas
ZIP/Postal Code
77355
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
Seattle Clinical Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Name
Medizinische Universitat Innsbruck
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Christian-Doppler-Klinik
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Paracelsus Medizinischen Privatuniversitaet - Christian-Doppler-Klinik (CDK)
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Calgary Headache & Assessment Management Program (CHAMP)
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3M 1M4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
OCT Research ULC
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1Z9
Country
Canada
Individual Site Status
Recruiting
Facility Name
James K. Lai MD Inc.
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1K3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centricity Research
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3S 1N2
Country
Canada
Individual Site Status
Recruiting
Facility Name
True North Clinical Research Inc.
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3S 1N2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Aggarwal and Associates Limited
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 0G1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Manna Research Inc. (Burlington North)
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7M 4Y1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Milestone Research Inc.
City
London
State/Province
Ontario
ZIP/Postal Code
N5W 6A2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Bluewater Clinical Research Group Inc.
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Mirtorabi Medicine Professional Corporation
City
Stouffville
State/Province
Ontario
ZIP/Postal Code
L4A 1H2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Toronto Memory Program
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3B 2S7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Manna Research (Toronto)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Diex Recherche Sherbrooke Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Hopital Gabriel Montpied
City
Clermont-Ferrand cedex
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Roger Salengro CHU Lille
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital de La Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Annecy Genevois
City
Pringy Cedex
ZIP/Postal Code
74374
Country
France
Individual Site Status
Recruiting
Facility Name
Klinische Forschung Karlsruhe GmbH
City
Karlsruhe
State/Province
Baden-württemberg
ZIP/Postal Code
76137
Country
Germany
Individual Site Status
Recruiting
Facility Name
Vitos Orthopaedische Klinik Kassel
City
Kassel
State/Province
Hessen
ZIP/Postal Code
34131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Arztepartnerschaft Dr. med. J. Springub/ W. Schwarz -Studienzentrum Nord-West
City
Westerstede
State/Province
Lower Saxony
ZIP/Postal Code
26655
Country
Germany
Individual Site Status
Recruiting
Facility Name
Siteworks - Zentrum fur klinische Studien Hannover
City
Hanover
State/Province
Lower-saxony
ZIP/Postal Code
30449
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinische Forschung Schwerin GmbH
City
Schwerin
State/Province
Mecklenburg-vorpommern
ZIP/Postal Code
19055
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitatsklinikum Jena
City
Jena
State/Province
Thuringia
ZIP/Postal Code
07747
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Klinische Forschung Berlin-Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Neurologisches Facharztzentrum Berlin (NFZB) - Sankt Gertrauden-Krankenhaus Location
City
Berlin
ZIP/Postal Code
10713
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Studienzentrum Dr. A Schwittay
City
Böhlen
ZIP/Postal Code
4564
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Klinische Forschung Dresden GmbH
City
Dresden
ZIP/Postal Code
01069
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitaetsklinikum Essen - Klinik und Poliklinik fuer Neurologie - Schwindel-Zentrum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Kopfschmerzzentrum Frankfurt
City
Frankfurt
ZIP/Postal Code
65929
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinische Forschung Hamburg GmbH
City
Hamburg
ZIP/Postal Code
20253
Country
Germany
Individual Site Status
Recruiting
Facility Name
Zentrum für klinische Studien Hannover
City
Hannover
ZIP/Postal Code
30449
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinische Forschung Karlsruhe GmbH
City
Karlsruhe
ZIP/Postal Code
76137
Country
Germany
Individual Site Status
Recruiting
Facility Name
Neurologisch-verhaltensmedizinische Schmerzklinik Kiel
City
Kiel
ZIP/Postal Code
24194
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Datamed GmbH
City
Koeln
ZIP/Postal Code
50935
Country
Germany
Individual Site Status
Recruiting
Facility Name
NeuroMed Campus - Neurologische Gemeinschaftspraxis am St. Elisabeth Krankenhaus
City
Koln
ZIP/Postal Code
50935
Country
Germany
Individual Site Status
Recruiting
Facility Name
Ludwig-Maximilians-Universitaet Muenchen Klinikum der Universitaet Muenchen - Campus Grosshadern
City
Munich
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Klinische Forschung Schwerin GmbH
City
Schwerin
ZIP/Postal Code
19055
Country
Germany
Individual Site Status
Recruiting
Facility Name
Fachuebergreifende Gemeinschaftspraxis Dr.Med. Joachim Springub & Wolfgang Schwarz
City
Westerstede
ZIP/Postal Code
no info
Country
Germany
Individual Site Status
Recruiting
Facility Name
AOU Careggi - Centro Cefalee
City
Firenze
State/Province
Florence
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Mondino - Istituto Neurologico Nazionale IRCCS
City
Pavia
State/Province
Padua
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Azienda Ospedaliera San Giuseppe Moscati-Unita di Neurologia
City
Avellino
ZIP/Postal Code
83100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
IRCCS Istituto delle Scienze Neurologiche Bologna
City
Bologna
ZIP/Postal Code
40139
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
ASST Spedali Civili di Brescia, U.O. Neurologia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Neurorehabilitation Unit-ICOT Istituto Marco Pasquali
City
Latina
ZIP/Postal Code
04100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
IRCCS San Raffaele Roma
City
Rome
ZIP/Postal Code
00197
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
52-210
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Pratia Bydgoszcz
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-796
Country
Poland
Individual Site Status
Recruiting
Facility Name
Indywidualna Praktyka Lekarska Dr Hab. Med. Anna Szczepanska-Szerej
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-582
Country
Poland
Individual Site Status
Recruiting
Facility Name
Krakowska Akademia Neurologii Sp. Z o.o.
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-505
Country
Poland
Individual Site Status
Recruiting
Facility Name
Krakowska Akademia Neurologil Sp. Z o.o.
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-505
Country
Poland
Individual Site Status
Recruiting
Facility Name
Next Stage Sp. Z o.o.
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-042
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wojskowy Instytut Medyczny
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
04-141
Country
Poland
Individual Site Status
Recruiting
Facility Name
Pratia MCM Krakow
City
Krakow
State/Province
Małopolskie
ZIP/Postal Code
30-510
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Pratia Czestochowa
City
Czestochowa
State/Province
Slaskie
ZIP/Postal Code
42-200
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Pratia Katowice
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-081
Country
Poland
Individual Site Status
Recruiting
Facility Name
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-123
Country
Poland
Individual Site Status
Recruiting
Facility Name
Solumed Centrum Medyczne
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-529
Country
Poland
Individual Site Status
Recruiting
Facility Name
NZOZ Neuromed M. i M. Nastaj Sp. P.
City
Lublin
ZIP/Postal Code
20-064
Country
Poland
Individual Site Status
Recruiting
Facility Name
MTZ Clinical Research Powered by Pratia
City
Warszawa
ZIP/Postal Code
02-172
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Hospital Clinico Universitario de Valladolid • HCUV
City
Valladolid
State/Province
Castilla Y LEON
ZIP/Postal Code
47003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Alvaro Cunqueiro
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36312
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Instituto de Investigaciones del Sueno
City
Madrid
ZIP/Postal Code
28036
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Virgen del Rocio Hospital
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Ladulaas Clinical Trials
City
Boras
State/Province
SE
ZIP/Postal Code
506 30
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Pharmasite
City
Malmö
State/Province
Skåne
ZIP/Postal Code
21152
Country
Sweden
Individual Site Status
Recruiting
Facility Name
CTC Clinical Trial Consultants AB
City
Stockholm
State/Province
Stockholms LÄN [se-01]
ZIP/Postal Code
171 64
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
ProbarE i Lund
City
Lund
ZIP/Postal Code
222 22
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Pharmasite
City
Malmö
ZIP/Postal Code
21152
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Studieenheten Akademiskt Specialistcentrum SLSO
City
Stockholm
ZIP/Postal Code
11361
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
Royal Primary Care Ashgate, Chesterfield Royal Hospital, NHS Foundation Trust
City
Chesterfield
State/Province
Derbyshire
ZIP/Postal Code
S40 4AA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Panthera Biopartners
City
Rochdale
State/Province
Great Manchester
ZIP/Postal Code
O11 4AU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Re:Cognition Health - Winchester
City
Winchester
State/Province
Hampshire
ZIP/Postal Code
SO21 1HU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Intelligent Clinical
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G20 0XA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Panthera Bio Partners
City
Preston
State/Province
Lancashire
ZIP/Postal Code
PR2 9QB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Re:Cognition Health - London
City
London
State/Province
Marylebone
ZIP/Postal Code
W1G 9JF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Re:Cognition Health-Private Practice
City
London
State/Province
Marylebone
ZIP/Postal Code
W1G9RU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
CPS Research
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G20 7BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Re-Cognition Health - Bristol
City
Bristol
State/Province
South WEST
ZIP/Postal Code
BS32 4SY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Panthera Biopartners - Sheffield
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S2 5FX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Re-Cognition Health
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7YD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Re-Cognition Health
City
Birmingham
State/Province
WEST Midlands
ZIP/Postal Code
B16 8LT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Panthera Biopartners Glasgow
City
Glasgow
ZIP/Postal Code
G51 4TY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Panthera Biopartners - Enfield
City
London
ZIP/Postal Code
EN3 4GS
Country
United Kingdom
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=BHV3000-404
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens

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