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Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use

Primary Purpose

Migraine

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Rimegepant
Placebo
Rimegepant
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, Acute Migraine, Headache, Acute treatment of Migraine in adults unsuitable for triptans

Eligibility Criteria

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

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 than 15 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.
  • Subjects on prophylactic migraine medication (excluding CGRP antagonists) are permitted to remain on therapy if they have been on a stable dose for at least 3 months (12 weeks) prior to the Screening Visit, and if the dose is not expected to change during the course of the study.
  • Triptan unsuitable

Exclusion Criteria:

-Target Disease Exclusion:

  1. History of cluster headache, basilar migraine, or hemiplegic migraine
  2. Current medication overuse headaches
  3. Headaches occurring 15 or more days per month (migraine or non-migraine) in any of the 3 months prior to the Screening Visit
  4. Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome [CRPS])
  5. 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

  • Clinical Research InstituteRecruiting
  • 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
  • WR-Mount Vernon Clinical Research, LLCRecruiting
  • Collective Medical ResearchRecruiting
  • DelRicht ResearchRecruiting
  • DelRicht ResearchRecruiting
  • Boston Clinical TrialsRecruiting
  • Community Clinical Research Network IncRecruiting
  • StudyMetrix Research
  • Clinvest Research, LLCRecruiting
  • Clinvest Research, LLCRecruiting
  • Montefiore Medical Center
  • New York Neurology Associates
  • Headache Wellness Center, PCRecruiting
  • Red Star Research, LLCRecruiting
  • DM Clinical ResearchRecruiting
  • Northwest Clinical Research CenterRecruiting
  • USC Clinical Trials CentreRecruiting
  • CerCare Pty Ltd
  • Alfred Hospital
  • Cabinet Privé Dr. Simona Sava
  • GZA Ziekenhuizen
  • UZ Brussel
  • UZ Gent
  • Jessa Ziekenhuis
  • Cabinet Privé Dr. Simona Sava
  • NeuPath Centre for Pain and Spine
  • Clinique Neuro-Lévis
  • Alpha Recherche CliniqueRecruiting
  • Alpha Recherche CliniqueRecruiting
  • Danish Headache CenterRecruiting
  • Helsinki Headache CenterRecruiting
  • Helsinki Headache Center
  • Terveystalo RuoholahtiRecruiting
  • Terveystalo Pulssi
  • CHU Nice Hopital Cimiez
  • Kopfschmerzzentrum Frankfurt
  • Helios DKD Hospital Wiesbaden
  • Twoja Przychodnia Nowosolskie Centrum Medyczne
  • Concept MedicaRecruiting
  • Instytut Zdrowia
  • Praktyka LekarskaRecruiting
  • Centrum Leczenia Bolu dr n med Lukasz Kmieciak
  • University Hospital Marqués de Valdecilla
  • University Hospital Marqués de ValdecillaRecruiting
  • Hospital Universitario Vall d'Hebron
  • Hospital Universitario La PazRecruiting
  • Virgen del Rocio University Hospital
  • Hospital Clínico Universitario de Valencia
  • CTC Solna
  • CTC Uppsala
  • Skåneuro Privatmottagning
  • CTC AB
  • Hälsoklustret
  • Akardo MedSite
  • CTC Uppsala

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rimegepant

Placebo

Arm Description

Rimegepant - Double-blind (DB) Phase: One dose of rimegepant 75 mg Oral Disintegrating Tablet (ODT) Rimegepant/Rimegepant - Open-label Extension (OLE) Phase: participants receive one dose rimegepant 75 mg ODT as needed for a qualifying acute migraine. A qualifying migraine is an attack of moderate or severe headache pain intensity. Migraine headache pain intensity will be measured on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe)

Placebo - Double-blind (DB) Phase: One dose of matching placebo Placebo/Rimegepant - Open-label Extension (OLE) Phase: participants receive one dose rimegepant 75 mg ODT for a qualifying migraine

Outcomes

Primary Outcome Measures

Compare the efficacy of rimegepant with placebo in the acute treatment of migraine, as measured by migraine headache pain relief at 2-hours post-dose during the Double-Blind Treatment (DBT) Phase.
Migraine headache pain relief will be assessed using the percentage of subjects with a headache pain intensity of none or mild. Migraine headache pain intensity will be measured on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe).

Secondary Outcome Measures

Full Information

First Posted
August 18, 2022
Last Updated
October 4, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05509400
Brief Title
Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use
Official Title
A Phase 4, Randomized, Double-blind Placebo-Controlled, Efficacy and Tolerability Trial of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2022 (Actual)
Primary Completion Date
November 17, 2024 (Anticipated)
Study Completion Date
March 7, 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 in a population of adults that are unsuitable for triptan medications due to a previous intolerance, lack of efficacy, or contraindication (including a history of clinically-relevant cardiovascular disease).
Detailed Description
This study is being conducted to evaluate the efficacy and tolerability of rimegepant in a population of adults that are unsuitable for triptan medications due to a previous intolerance, lack of efficacy, or contraindication (including a history of clinically-relevant cardiovascular disease). Rimegepant will be further evaluated in this population with as needed use in a 12-week, open-label extension study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, Acute Migraine, Headache, Acute treatment of Migraine in adults unsuitable for triptans

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Rimegepant
Arm Type
Experimental
Arm Description
Rimegepant - Double-blind (DB) Phase: One dose of rimegepant 75 mg Oral Disintegrating Tablet (ODT) Rimegepant/Rimegepant - Open-label Extension (OLE) Phase: participants receive one dose rimegepant 75 mg ODT as needed for a qualifying acute migraine. A qualifying migraine is an attack of moderate or severe headache pain intensity. Migraine headache pain intensity will be measured on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo - Double-blind (DB) Phase: One dose of matching placebo Placebo/Rimegepant - Open-label Extension (OLE) Phase: participants receive one dose rimegepant 75 mg ODT for a qualifying migraine
Intervention Type
Drug
Intervention Name(s)
Rimegepant
Intervention Description
DB Phase: Rimegepant 75 mg Orally Disintegrating Tablet (ODT)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
DB Phase: matching placebo
Intervention Type
Drug
Intervention Name(s)
Rimegepant
Intervention Description
OLE Phase: Rimegepant 75 mg ODT in association with each of the first 5 qualifying migraines
Primary Outcome Measure Information:
Title
Compare the efficacy of rimegepant with placebo in the acute treatment of migraine, as measured by migraine headache pain relief at 2-hours post-dose during the Double-Blind Treatment (DBT) Phase.
Description
Migraine headache pain relief will be assessed using the percentage of subjects with a headache pain intensity of none or mild. Migraine headache pain intensity will be measured on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe).
Time Frame
2 hours post-dose

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 than 15 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. Subjects on prophylactic migraine medication (excluding CGRP antagonists) are permitted to remain on therapy if they have been on a stable dose for at least 3 months (12 weeks) prior to the Screening Visit, and if the dose is not expected to change during the course of the study. Triptan unsuitable Exclusion Criteria: -Target Disease Exclusion: History of cluster headache, basilar migraine, or hemiplegic migraine Current medication overuse headaches Headaches occurring 15 or more days per month (migraine or non-migraine) in any of the 3 months prior to the Screening Visit 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
Clinical Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
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
WR-Mount Vernon Clinical Research, LLC
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
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
DelRicht Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Individual Site Status
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
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
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
New York Neurology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10003
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
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 Centre
City
Sippy Downs
State/Province
Queensland
ZIP/Postal Code
4556
Country
Australia
Individual Site Status
Recruiting
Facility Name
CerCare Pty Ltd
City
Wayville
State/Province
South Australia
ZIP/Postal Code
5034
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Cabinet Privé Dr. Simona Sava
City
Saint Nicolas
State/Province
Liège
ZIP/Postal Code
4420
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
UZ Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
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
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
Not yet 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
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
ZIP/Postal Code
2600
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Helsinki Headache Center
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00830
Country
Finland
Individual Site Status
Recruiting
Facility Name
Helsinki Headache Center
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
830
Country
Finland
Individual Site Status
Not yet recruiting
Facility Name
Terveystalo Ruoholahti
City
Helsinki
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
CHU Nice Hopital Cimiez
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Kopfschmerzzentrum Frankfurt
City
Frankfurt
ZIP/Postal Code
65929
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Helios DKD Hospital Wiesbaden
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Twoja Przychodnia Nowosolskie Centrum Medyczne
City
Nowa Sol
State/Province
Lubuskie
ZIP/Postal Code
67-100
Country
Poland
Individual Site Status
Not yet 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
Praktyka Lekarska
City
Warszawa
ZIP/Postal Code
00-144
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Leczenia Bolu dr n med Lukasz Kmieciak
City
Łódź
State/Province
Łódzkie
ZIP/Postal Code
91-363
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
University Hospital Marqués de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
University Hospital Marqués de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
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 La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
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
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 Uppsala
City
Uppsala
State/Province
Uppsala LÄN
ZIP/Postal Code
752 37
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
CTC AB
City
Solna Stockholm
ZIP/Postal Code
171 64
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 MedSite
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=BHV3000-406
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 Acute Treatment of Migraine in Adults Unsuitable for Triptan Use

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