Back to resultsEfficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of Inadequate Response to Oral Preventive Medications
Primary Purpose
Migraine
Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Rimegepant
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Migraine focused on measuring Migraine Prevention, Headache, Headache Prevention, Migraine Prevention in adults with inadequate response to oral preventative medications
Eligibility Criteria
Inclusion Criteria:
- Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
- Migraine attacks, on average, lasting about 4 - 72 hours, if untreated.
- 4 to 14 migraine days per month, on average, across the 3 months prior to the Screening Visit (month is defined as 28-days for the purpose of this protocol).
- Less than15 headache days (migraine or non-migraine) per month in each of the 3-months prior to the Screening Visit and throughout the Screening Phase.
- Subjects must be able to distinguish migraine attacks from tension/cluster headaches. Prior inadequate response, within 10 years of the Screening Visit, to agents across 2-4 categories of recognized, orally-administered, migraine-preventive medications where at least one example of prior inadequate response is due to lack of efficacy or prior intolerance (not contraindication).
Exclusion Criteria:
- History of cluster headaches, basilar migraine (migraine with brainstem aura), or hemiplegic migraine.
- Current medication overuse headaches.
- 15 or more headache days (migraine or non-migraine) per month in any of the 3-months prior to the Screening Visit or during the 28- day Observation Phase.
- Inadequate response (due to lack of efficacy, prior intolerance, or contraindication) to agents across > 4 categories of recognized, orally administered, migraine-preventive medications.
- Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome [CRPS]).
- Other pain syndromes (including trigeminal neuralgia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, interfere with study assessments of safety or efficacy.
Sites / Locations
- California Neuroscience Research, LLCRecruiting
- Ki Health Partners LLC, dba New England Institute for Clinical ResearchRecruiting
- Complete Health Research
- Sandhill Research, LLC d/b/a Accel Research Sites Network-Edgewater Clinical Research Unit
- Wr-Msra,LlcRecruiting
- AppleMed Research Group, LLC
- Sandhill Research, LLC d/b/a Accel Research Sites Network - Ormond Clinical Research UnitRecruiting
- Boston Clinical TrialsRecruiting
- Community Clinical Research Network, Inc.Recruiting
- StudyMetrix Research
- Clinvest Research, LLCRecruiting
- Clinvest Research, LLC
- Wr-Crcn, LlcRecruiting
- Albuquerque Clinical Trials. Inc.Recruiting
- Montefiore Medical Center
- Headache Wellness Center, PCRecruiting
- Alliance for Multispecialty Reseach, LLCRecruiting
- Red Star Research, LLCRecruiting
- DM Clinical ResearchRecruiting
- Northwest Clinical Research CenterRecruiting
- USC Clinical Trials Sunshine Coast
- UZ Brussel
- GZA Ziekenhuizen
- AZ Sint-Jan
- UZ Brussel
- Jessa Ziekenhuis
- Clinique de la Citadelle
- Cabinet Privé Dr. Simona Sava
- NeuPath Centre for Pain and SpineRecruiting
- Clinique Neuro-Lévis
- Centre de Recherche Saint-Louis/Clinique Neuro-Levis
- Diex Recherche Sherbrooke Inc.
- Alpha Recherche CliniqueRecruiting
- ALPHA Recherche CliniqueRecruiting
- Danish Headache Center
- Terveystalo Oy
- Terveystalo RuoholahtiRecruiting
- Terveystalo TampereRecruiting
- Terveystalo Pulssi
- Centrum Medyczne NeuromedRecruiting
- Concept MedicaRecruiting
- Instytut Zdrowia
- Vita Longa Sp. Z o.o.
- Centermed Kraków Sp. Z o.o.
- Praktyka LekarskaRecruiting
- Premium Clinic WrocławRecruiting
- Headache Management Centre
- Hospital de la Princesa
- Hospital HM SanchinarroRecruiting
- Hospital General de Valencia
- Hospital Clinic de Barcelona Plato Headquarters
- Hospital Universitario Vall d'Hebron
- Hospital Universitario de La Princesa
- Hospital Universitario Fundacion Jimenez DiazRecruiting
- Hospital Universitario La Paz
- Hospital HM SanchinarroRecruiting
- Hospital Universitario HM SanchinarroRecruiting
- University Hospital Marqués de ValdecillaRecruiting
- Hospital Universitario Virgen Macarena
- Virgen del Rocio University Hospital
- Hospital Clínico Universitario de Valencia
- Hospital Universitario de ValladolidRecruiting
- Hospital Clinico Universitario de ValladolidRecruiting
- CTC Solna
- CTC MTC
- CTC Uppsala
- Carlanderska Hospital
- Skåneuro Privatmottagning
- Hälsoklustret
- Akardo Med Site
- CTC Uppsala
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Rimegepant 75 mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Compare the efficacy of rimegepant (75 mg) to placebo
Subjects are dosed every other day, for the preventative treatment of migraine as measured by mean change in number of migraine days per month (28 days) over 12 week DBT Phase. A migraine day is any calendar day in which the subject experiences a qualified migraine headache. This includes any calendar day in which the subject takes an acute migraine-specific medication.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05518123
Brief Title
Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of Inadequate Response to Oral Preventive Medications
Official Title
A Phase 4, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With a History of Inadequate Response to Oral Preventive Medications
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
August 15, 2024 (Anticipated)
Study Completion Date
February 10, 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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is being conducted to evaluate the efficacy and tolerability of rimegepant for migraine prophylaxis in adults with a history of inadequate response to oral preventive medications
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine Prevention, Headache, Headache Prevention, Migraine Prevention in adults with inadequate response to oral preventative medications
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rimegepant 75 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Rimegepant
Intervention Description
Rimegepant 75 mg Oral Disintegrating Tablet (ODT) taken every other day during Double-blind Treatment (DBT) phase
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo with every other day dosing during DBT phase
Primary Outcome Measure Information:
Title
Compare the efficacy of rimegepant (75 mg) to placebo
Description
Subjects are dosed every other day, for the preventative treatment of migraine as measured by mean change in number of migraine days per month (28 days) over 12 week DBT Phase. A migraine day is any calendar day in which the subject experiences a qualified migraine headache. This includes any calendar day in which the subject takes an acute migraine-specific medication.
Time Frame
Week 1 to 12 of DBT Phase
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
Migraine attacks, on average, lasting about 4 - 72 hours, if untreated.
4 to 14 migraine days per month, on average, across the 3 months prior to the Screening Visit (month is defined as 28-days for the purpose of this protocol).
Less than15 headache days (migraine or non-migraine) per month in each of the 3-months prior to the Screening Visit and throughout the Screening Phase.
Subjects must be able to distinguish migraine attacks from tension/cluster headaches. Prior inadequate response, within 10 years of the Screening Visit, to agents across 2-4 categories of recognized, orally-administered, migraine-preventive medications where at least one example of prior inadequate response is due to lack of efficacy or prior intolerance (not contraindication).
Exclusion Criteria:
History of cluster headaches, basilar migraine (migraine with brainstem aura), or hemiplegic migraine.
Current medication overuse headaches.
15 or more headache days (migraine or non-migraine) per month in any of the 3-months prior to the Screening Visit or during the 28- day Observation Phase.
Inadequate response (due to lack of efficacy, prior intolerance, or contraindication) to agents across > 4 categories of recognized, orally administered, migraine-preventive medications.
Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome [CRPS]).
Other pain syndromes (including trigeminal neuralgia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, interfere with study assessments of safety or efficacy.
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
California Neuroscience Research, LLC
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
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
Complete Health Research
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Sandhill Research, LLC d/b/a Accel Research Sites Network-Edgewater Clinical Research Unit
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Wr-Msra,Llc
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
Not yet recruiting
Facility Name
Sandhill Research, LLC d/b/a Accel Research Sites Network - Ormond Clinical Research Unit
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
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
Community Clinical Research Network, Inc.
City
Marlborough
State/Province
Massachusetts
ZIP/Postal Code
01752
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
Not yet 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
Not yet 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
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Headache Wellness Center, PC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance for Multispecialty Reseach, LLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
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
DM Clinical Research
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Individual Site Status
Recruiting
Facility Name
USC Clinical Trials Sunshine Coast
City
Sippy Downs
State/Province
Queensland
ZIP/Postal Code
4556
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
UZ Brussel
City
Jette
State/Province
Brussels
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
GZA Ziekenhuizen
City
Antwerpen
ZIP/Postal Code
2610
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
AZ Sint-Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
UZ Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Clinique de la Citadelle
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Cabinet Privé Dr. Simona Sava
City
Saint Nicolas Province De Liège
ZIP/Postal Code
4420
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
NeuPath Centre for Pain and Spine
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6V 1C2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Clinique Neuro-Lévis
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6W 0M5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Centre de Recherche Saint-Louis/Clinique Neuro-Levis
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6W0M5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Diex Recherche Sherbrooke Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Alpha Recherche Clinique
City
Quebec
ZIP/Postal Code
G2J 0C4
Country
Canada
Individual Site Status
Recruiting
Facility Name
ALPHA Recherche Clinique
City
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Danish Headache Center
City
Glostrup
State/Province
Region Hovedstaden
ZIP/Postal Code
2600
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Name
Terveystalo Oy
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Individual Site Status
Not yet recruiting
Facility Name
Terveystalo Ruoholahti
City
Helsinki
ZIP/Postal Code
00180
Country
Finland
Individual Site Status
Recruiting
Facility Name
Terveystalo Tampere
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Individual Site Status
Recruiting
Facility Name
Terveystalo Pulssi
City
Turku
ZIP/Postal Code
20100
Country
Finland
Individual Site Status
Not yet recruiting
Facility Name
Centrum Medyczne Neuromed
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-163
Country
Poland
Individual Site Status
Recruiting
Facility Name
Concept Medica
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-773
Country
Poland
Individual Site Status
Recruiting
Facility Name
Instytut Zdrowia
City
Oświęcim
State/Province
Małopolska
ZIP/Postal Code
32-600
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Vita Longa Sp. Z o.o.
City
Katowice
ZIP/Postal Code
40-748
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Centermed Kraków Sp. Z o.o.
City
Kraków
ZIP/Postal Code
31-530
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Praktyka Lekarska
City
Warszawa
ZIP/Postal Code
00-144
Country
Poland
Individual Site Status
Recruiting
Facility Name
Premium Clinic Wrocław
City
Wroclaw
ZIP/Postal Code
50-414
Country
Poland
Individual Site Status
Recruiting
Facility Name
Headache Management Centre
City
Łódź
State/Province
Łódzkie
ZIP/Postal Code
91-363
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Hospital de la Princesa
City
Madrid
State/Province
Madrid, Comunidad DE
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital HM Sanchinarro
City
Sanchinarro
State/Province
Madrid, Comunidad DE
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General de Valencia
City
Valencia
State/Province
València
ZIP/Postal Code
46014
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Clinic de Barcelona Plato Headquarters
City
Barcelona
ZIP/Postal Code
08006
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital HM Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario HM Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
University Hospital Marqués de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Virgen del Rocio University Hospital
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47010
Country
Spain
Individual Site Status
Recruiting
Facility Name
CTC Solna
City
Solna
State/Province
Stockholms LÄN [se-01]
ZIP/Postal Code
171 64
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
CTC MTC
City
Uppsala
State/Province
Uppsala LÄN [se-03]
ZIP/Postal Code
752 37
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
CTC Uppsala
City
Uppsala
State/Province
Uppsala LÄN [se-03]
ZIP/Postal Code
75237
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
Carlanderska Hospital
City
Gothenburg
ZIP/Postal Code
41255
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
Skåneuro Privatmottagning
City
Lund
ZIP/Postal Code
222 22
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
Hälsoklustret
City
Stockholm
ZIP/Postal Code
112 39
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
Akardo Med Site
City
Stockholm
ZIP/Postal Code
117 27
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
CTC Uppsala
City
Uppsala
ZIP/Postal Code
752 37
Country
Sweden
Individual Site Status
Not yet 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=BHV3000-407
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of Inadequate Response to Oral Preventive Medications
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