Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05509400




Registration number
NCT05509400
Ethics application status
Date submitted
18/08/2022
Date registered
22/08/2022
Date last updated
20/11/2024

Titles & IDs
Public title
Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use
Scientific title
BHV3000-406 (C4951004): 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
Secondary ID [1] 0 0
C4951004
Secondary ID [2] 0 0
BHV3000-406
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraine 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rimegepant
Treatment: Drugs - Placebo
Treatment: Drugs - Rimegepant

Experimental: Rimegepant - 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 comparator: Placebo - 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


Treatment: Drugs: Rimegepant
DB Phase: Rimegepant 75 mg Orally Disintegrating Tablet (ODT)

Treatment: Drugs: Placebo
DB Phase: matching placebo

Treatment: Drugs: Rimegepant
OLE Phase: Rimegepant 75 mg ODT in association with each of the first 5 qualifying migraines
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
2 hours post-dose

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/08/2025
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
USC Clinical Trials Centre - Sippy Downs
Recruitment hospital [2] 0 0
PainMedSA & CerCare Pty Ltd - Wayville
Recruitment hospital [3] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [2] 0 0
5034 - Wayville
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Austria
State/province [15] 0 0
Carinthia
Country [16] 0 0
Austria
State/province [16] 0 0
Tirol
Country [17] 0 0
Austria
State/province [17] 0 0
Klagenfurt am Wörthersee
Country [18] 0 0
Austria
State/province [18] 0 0
Vienna
Country [19] 0 0
Belgium
State/province [19] 0 0
Liège
Country [20] 0 0
Belgium
State/province [20] 0 0
Antwerpen
Country [21] 0 0
Belgium
State/province [21] 0 0
Brussels
Country [22] 0 0
Belgium
State/province [22] 0 0
Gent
Country [23] 0 0
Belgium
State/province [23] 0 0
Hasselt
Country [24] 0 0
Belgium
State/province [24] 0 0
Saint Nicolas Province De Liège
Country [25] 0 0
Canada
State/province [25] 0 0
Alberta
Country [26] 0 0
Canada
State/province [26] 0 0
Ontario
Country [27] 0 0
Canada
State/province [27] 0 0
Quebec
Country [28] 0 0
Denmark
State/province [28] 0 0
Capital Region
Country [29] 0 0
Denmark
State/province [29] 0 0
Copenhagen
Country [30] 0 0
Denmark
State/province [30] 0 0
Esbjerg
Country [31] 0 0
Denmark
State/province [31] 0 0
Glostrup
Country [32] 0 0
Denmark
State/province [32] 0 0
Viborg
Country [33] 0 0
Finland
State/province [33] 0 0
Uusimaa
Country [34] 0 0
Finland
State/province [34] 0 0
Helsinki
Country [35] 0 0
Finland
State/province [35] 0 0
Tampere
Country [36] 0 0
Finland
State/province [36] 0 0
Turku
Country [37] 0 0
France
State/province [37] 0 0
Haute-savoie
Country [38] 0 0
France
State/province [38] 0 0
Loire
Country [39] 0 0
France
State/province [39] 0 0
Provence
Country [40] 0 0
France
State/province [40] 0 0
Bron
Country [41] 0 0
France
State/province [41] 0 0
Clermont-Ferrand
Country [42] 0 0
France
State/province [42] 0 0
Epagny Metz-Tessy
Country [43] 0 0
France
State/province [43] 0 0
Lille
Country [44] 0 0
France
State/province [44] 0 0
Marseille
Country [45] 0 0
France
State/province [45] 0 0
Nice
Country [46] 0 0
France
State/province [46] 0 0
Paris
Country [47] 0 0
France
State/province [47] 0 0
Saint-Etienne Cedex 2
Country [48] 0 0
Germany
State/province [48] 0 0
Hessen
Country [49] 0 0
Germany
State/province [49] 0 0
Mecklenburg-vorpommern
Country [50] 0 0
Germany
State/province [50] 0 0
Schleswig-holstein
Country [51] 0 0
Germany
State/province [51] 0 0
Thüringen
Country [52] 0 0
Germany
State/province [52] 0 0
Berlin
Country [53] 0 0
Germany
State/province [53] 0 0
Frankfurt
Country [54] 0 0
Germany
State/province [54] 0 0
Greifswald
Country [55] 0 0
Germany
State/province [55] 0 0
Jena
Country [56] 0 0
Germany
State/province [56] 0 0
Kiel
Country [57] 0 0
Germany
State/province [57] 0 0
Wiesbaden
Country [58] 0 0
Italy
State/province [58] 0 0
BA
Country [59] 0 0
Italy
State/province [59] 0 0
MI
Country [60] 0 0
Italy
State/province [60] 0 0
Naples
Country [61] 0 0
Italy
State/province [61] 0 0
Puglia
Country [62] 0 0
Italy
State/province [62] 0 0
RM
Country [63] 0 0
Italy
State/province [63] 0 0
Rome
Country [64] 0 0
Italy
State/province [64] 0 0
Milano
Country [65] 0 0
Italy
State/province [65] 0 0
Modena
Country [66] 0 0
Italy
State/province [66] 0 0
Pavia
Country [67] 0 0
Mexico
State/province [67] 0 0
Estado DE Mexico
Country [68] 0 0
Mexico
State/province [68] 0 0
Aguascalientes
Country [69] 0 0
Mexico
State/province [69] 0 0
Mexico City
Country [70] 0 0
Poland
State/province [70] 0 0
Dolnoslaskie
Country [71] 0 0
Poland
State/province [71] 0 0
Kujawsko-pomorskie
Country [72] 0 0
Poland
State/province [72] 0 0
Lubuskie
Country [73] 0 0
Poland
State/province [73] 0 0
Mazowieckie
Country [74] 0 0
Poland
State/province [74] 0 0
Malopolska
Country [75] 0 0
Poland
State/province [75] 0 0
Katowice
Country [76] 0 0
Poland
State/province [76] 0 0
Szczecin
Country [77] 0 0
Poland
State/province [77] 0 0
Warsaw
Country [78] 0 0
Poland
State/province [78] 0 0
Warszawa
Country [79] 0 0
Poland
State/province [79] 0 0
Lódzkie
Country [80] 0 0
Spain
State/province [80] 0 0
Cantabria
Country [81] 0 0
Spain
State/province [81] 0 0
Barcelona
Country [82] 0 0
Spain
State/province [82] 0 0
Madrid
Country [83] 0 0
Spain
State/province [83] 0 0
Salamanca, Madrid
Country [84] 0 0
Spain
State/province [84] 0 0
Sevilla
Country [85] 0 0
Spain
State/province [85] 0 0
Valencia
Country [86] 0 0
Sweden
State/province [86] 0 0
Stockholms LÄN [se-01]
Country [87] 0 0
Sweden
State/province [87] 0 0
Uppsala LÄN
Country [88] 0 0
Sweden
State/province [88] 0 0
Lund
Country [89] 0 0
Sweden
State/province [89] 0 0
Solna Stockholm
Country [90] 0 0
Sweden
State/province [90] 0 0
Stockholm
Country [91] 0 0
Sweden
State/province [91] 0 0
Uppsala
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Birmingham
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Essex
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Northamptonshire
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Oxfordshire
Country [96] 0 0
United Kingdom
State/province [96] 0 0
London
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Swinton, Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT05509400
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pfizer Pfizer CT.gov Call Center
Address 0 0
Country 0 0
Phone 0 0
1-800-718-1021
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05509400