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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    		 2021-005239-22
    Trial protocol
    		 ES   AT   FR   SE   IT   PL  
    Global end of trial date
    10 Dec 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Dec 2025
    First version publication date
    24 Dec 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    C4951010
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05217927
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Study ID: BHV3000-404
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    66 Hudson Boulevard East, New York, United States, NY 10001
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 Jun 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Dec 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of every other day (EOD) and daily rimegepant dosing regimens relative to placebo as a preventive treatment for episodic migraine, as measured by the mean reduction from the Observation Phase in the number of migraine days per month over the entire Double-blind Treatment (DBT) Phase.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Mar 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 4
    Country: Number of subjects enrolled
    Canada: 31
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Germany: 52
    Country: Number of subjects enrolled
    Italy: 30
    Country: Number of subjects enrolled
    Poland: 165
    Country: Number of subjects enrolled
    Spain: 44
    Country: Number of subjects enrolled
    Sweden: 15
    Country: Number of subjects enrolled
    United States: 216
    Country: Number of subjects enrolled
    United Kingdom: 133
    Worldwide total number of subjects
    692
    EEA total number of subjects
    312
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    669
    From 65 to 84 years
    23
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This study was conducted to evaluate the efficacy, safety, and tolerability of once every other day (EOD) and daily rimegepant dosing regimens for the prevention of episodic migraine.

    Pre-assignment
    Screening details
    		 A total of 1415 participants were enrolled in the study, of which 716 failed screening and 699 participants were randomized. Of the 699 randomized participants, 692 participantsreceived the study intervention.

    Period 1
    Period 1 title
    DBT Phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject
    Blinding implementation details
    Double blinded study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DB Rimegepant/ Placebo/ OL Rimegepant
    Arm description
    		 Participants received rimegepant (RMG) 75 mg, orally disintegrating tablets (ODT), EOD alternating with matching placebo dosed EOD for 12 weeks in the double blind treatment (DBT) phase. Eligible participants received RMG 75 mg ODT once daily (QD) for 12 weeks in the open label extension (OLE) phase. Participants were followed up for 8 weeks after last dose of study drug.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo of Rimegepant was administered PO.

    Investigational medicinal product name
    Rimegepant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Rimegepant 75 mg was administered orally (PO).

    Arm title
    		 DB Rimegepant/OL Rimegepant
    Arm description
    		 Participants received RMG 75 mg ODT, once daily for 12 weeks in the DBT phase. Eligible participants continued to receive RMG 75 mg ODT once daily for 12 weeks in the OLE phase. Participants were followed up for 8 weeks after last dose of study drug.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rimegepant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Rimegepant 75 mg was administered PO.

    Arm title
    		 DB Placebo/OL Rimegepant
    Arm description
    		 Participants received matching placebo for RMG 75 mg ODT once daily for 12 weeks, in the DBT phase. Eligible participants received RMG 75 mg ODT once daily for 12 weeks in the OLE phase. Participants were followed up for 8 weeks after last dose of study drug.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo of Rimegepant was administered PO.

    Investigational medicinal product name
    Rimegepant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Rimegepant 75 mg was administered PO.

    Number of subjects in period 1
    		DB Rimegepant/ Placebo/ OL Rimegepant DB Rimegepant/OL Rimegepant DB Placebo/OL Rimegepant
    Started
    232
    229
    231
    Completed
    204
    209
    208
    Not completed
    28
    20
    23
         Adverse event, non-fatal
    7
    2
    5
         Protocol-specified withdrawal criterion met
    4
    6
    5
         Pregnancy
    -
    -
    1
         Non-compliance
    1
    -
    -
         Withdrawal of consent
    8
    5
    7
         Unspecified
    7
    3
    4
         Lost to follow-up
    -
    2
    -
         Lack of efficacy
    1
    -
    -
         Protocol deviation
    -
    2
    1
    Period 2
    Period 2 title
    DBT Phase to OLE phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Double blinded study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DB Rimegepant/ Placebo/ OL Rimegepant
    Arm description
    		 Participants received rimegepant (RMG) 75 mg, orally disintegrating tablets (ODT), EOD alternating with matching placebo dosed EOD for 12 weeks in the double blind treatment (DBT) phase. Eligible participants received RMG 75 mg ODT once daily (QD) for 12 weeks in the open label extension (OLE) phase. Participants were followed up for 8 weeks after last dose of study drug.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo of Rimegepant was administered PO.

    Investigational medicinal product name
    Rimegepant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Rimegepant 75 mg was administered orally.

    Arm title
    		 DB Rimegepant/OL Rimegepant
    Arm description
    		 Participants received RMG 75 mg ODT, once daily for 12 weeks in the DBT phase. Eligible participants continued to receive RMG 75 mg ODT once daily for 12 weeks in the OLE phase. Participants were followed up for 8 weeks after last dose of study drug.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rimegepant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Rimegepant 75 mg was administered PO.

    Arm title
    		 DB Placebo/OL Rimegepant
    Arm description
    		 Participants received matching placebo for RMG 75 mg ODT once daily for 12 weeks, in the DBT phase. Eligible participants received RMG 75 mg ODT once daily for 12 weeks in the OLE phase. Participants were followed up for 8 weeks after last dose of study drug.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo of Rimegepant was administered PO.

    Investigational medicinal product name
    Rimegepant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Rimegepant 75 mg was administered orally.

    Number of subjects in period 2
    		DB Rimegepant/ Placebo/ OL Rimegepant DB Rimegepant/OL Rimegepant DB Placebo/OL Rimegepant
    Started
    204
    209
    208
    Completed
    182
    196
    195
    Not completed
    22
    13
    13
         Did not enter the OLE phase
    22
    13
    13
    Period 3
    Period 3 title
    OLE Phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Double blinded study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DB Rimegepant/ Placebo/ OL Rimegepant
    Arm description
    		 Participants received rimegepant (RMG) 75 mg, orally disintegrating tablets (ODT), EOD alternating with matching placebo dosed EOD for 12 weeks in the double blind treatment (DBT) phase. Eligible participants received RMG 75 mg ODT once daily (QD) for 12 weeks in the open label extension (OLE) phase. Participants were followed up for 8 weeks after last dose of study drug.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo of Rimegepant was administered PO.

    Investigational medicinal product name
    Rimegepant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Rimegepant 75 mg was administered PO.

    Arm title
    		 DB Rimegepant/OL Rimegepant
    Arm description
    		 Participants received RMG 75 mg ODT, once daily for 12 weeks in the DBT phase. Eligible participants continued to receive RMG 75 mg ODT once daily for 12 weeks in the OLE phase. Participants were followed up for 8 weeks after last dose of study drug.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rimegepant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Rimegepant 75 mg was administered PO.

    Arm title
    		 DB Placebo/OL Rimegepant
    Arm description
    		 Participants received matching placebo for RMG 75 mg ODT once daily for 12 weeks, in the DBT phase. Eligible participants received RMG 75 mg ODT once daily for 12 weeks in the OLE phase. Participants were followed up for 8 weeks after last dose of study drug.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo of Rimegepant was administered PO.

    Investigational medicinal product name
    Rimegepant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Rimegepant 75 mg was administered PO.

    Number of subjects in period 3
    		DB Rimegepant/ Placebo/ OL Rimegepant DB Rimegepant/OL Rimegepant DB Placebo/OL Rimegepant
    Started
    182
    196
    195
    Completed
    170
    187
    183
    Not completed
    12
    9
    12
         Extension phase eligibility failure
    1
    -
    -
         Adverse event, non-fatal
    4
    1
    1
         Non-compliance
    -
    -
    1
         Unspecified
    3
    5
    4
         Withdrawal of consent
    3
    1
    5
         Lost to follow-up
    1
    2
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    DB Rimegepant/ Placebo/ OL Rimegepant
    Reporting group description
    		 Participants received rimegepant (RMG) 75 mg, orally disintegrating tablets (ODT), EOD alternating with matching placebo dosed EOD for 12 weeks in the double blind treatment (DBT) phase. Eligible participants received RMG 75 mg ODT once daily (QD) for 12 weeks in the open label extension (OLE) phase. Participants were followed up for 8 weeks after last dose of study drug.

    Reporting group title
    DB Rimegepant/OL Rimegepant
    Reporting group description
    		 Participants received RMG 75 mg ODT, once daily for 12 weeks in the DBT phase. Eligible participants continued to receive RMG 75 mg ODT once daily for 12 weeks in the OLE phase. Participants were followed up for 8 weeks after last dose of study drug.

    Reporting group title
    DB Placebo/OL Rimegepant
    Reporting group description
    		 Participants received matching placebo for RMG 75 mg ODT once daily for 12 weeks, in the DBT phase. Eligible participants received RMG 75 mg ODT once daily for 12 weeks in the OLE phase. Participants were followed up for 8 weeks after last dose of study drug.

    Reporting group values
    		 DB Rimegepant/ Placebo/ OL Rimegepant DB Rimegepant/OL Rimegepant DB Placebo/OL Rimegepant Total
    Number of subjects
    		 232 229 231
    Age Categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.0 ( 11.96 ) 43.9 ( 12.05 ) 42.9 ( 12.35 ) -
    Gender categorical
    Units: Subjects
        Male
    		 201 192 207 600
        Female
    		 31 37 24 92

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    DB Rimegepant/ Placebo/ OL Rimegepant
    Reporting group description
    		 Participants received rimegepant (RMG) 75 mg, orally disintegrating tablets (ODT), EOD alternating with matching placebo dosed EOD for 12 weeks in the double blind treatment (DBT) phase. Eligible participants received RMG 75 mg ODT once daily (QD) for 12 weeks in the open label extension (OLE) phase. Participants were followed up for 8 weeks after last dose of study drug.

    Reporting group title
    DB Rimegepant/OL Rimegepant
    Reporting group description
    		 Participants received RMG 75 mg ODT, once daily for 12 weeks in the DBT phase. Eligible participants continued to receive RMG 75 mg ODT once daily for 12 weeks in the OLE phase. Participants were followed up for 8 weeks after last dose of study drug.

    Reporting group title
    DB Placebo/OL Rimegepant
    Reporting group description
    		 Participants received matching placebo for RMG 75 mg ODT once daily for 12 weeks, in the DBT phase. Eligible participants received RMG 75 mg ODT once daily for 12 weeks in the OLE phase. Participants were followed up for 8 weeks after last dose of study drug.
    Reporting group title
    DB Rimegepant/ Placebo/ OL Rimegepant
    Reporting group description
    		 Participants received rimegepant (RMG) 75 mg, orally disintegrating tablets (ODT), EOD alternating with matching placebo dosed EOD for 12 weeks in the double blind treatment (DBT) phase. Eligible participants received RMG 75 mg ODT once daily (QD) for 12 weeks in the open label extension (OLE) phase. Participants were followed up for 8 weeks after last dose of study drug.

    Reporting group title
    DB Rimegepant/OL Rimegepant
    Reporting group description
    		 Participants received RMG 75 mg ODT, once daily for 12 weeks in the DBT phase. Eligible participants continued to receive RMG 75 mg ODT once daily for 12 weeks in the OLE phase. Participants were followed up for 8 weeks after last dose of study drug.

    Reporting group title
    DB Placebo/OL Rimegepant
    Reporting group description
    		 Participants received matching placebo for RMG 75 mg ODT once daily for 12 weeks, in the DBT phase. Eligible participants received RMG 75 mg ODT once daily for 12 weeks in the OLE phase. Participants were followed up for 8 weeks after last dose of study drug.
    Reporting group title
    DB Rimegepant/ Placebo/ OL Rimegepant
    Reporting group description
    		 Participants received rimegepant (RMG) 75 mg, orally disintegrating tablets (ODT), EOD alternating with matching placebo dosed EOD for 12 weeks in the double blind treatment (DBT) phase. Eligible participants received RMG 75 mg ODT once daily (QD) for 12 weeks in the open label extension (OLE) phase. Participants were followed up for 8 weeks after last dose of study drug.

    Reporting group title
    DB Rimegepant/OL Rimegepant
    Reporting group description
    		 Participants received RMG 75 mg ODT, once daily for 12 weeks in the DBT phase. Eligible participants continued to receive RMG 75 mg ODT once daily for 12 weeks in the OLE phase. Participants were followed up for 8 weeks after last dose of study drug.

    Reporting group title
    DB Placebo/OL Rimegepant
    Reporting group description
    		 Participants received matching placebo for RMG 75 mg ODT once daily for 12 weeks, in the DBT phase. Eligible participants received RMG 75 mg ODT once daily for 12 weeks in the OLE phase. Participants were followed up for 8 weeks after last dose of study drug.

    Subject analysis set title
    DB Rimegepant/ Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received RMG 75 mg, ODT, once EOD alternating with matching placebo dosed EOD for 12 weeks in the DBT phase. Participants were followed up for 8 weeks after last dose of study drug.

    Subject analysis set title
    DB Rimegepant
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received RMG 75 mg ODT, once daily for 12 weeks in the DBT phase. Participants were followed up for 8 weeks after last dose of study drug.

    Subject analysis set title
    DB Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received matching placebo for RMG 75 mg ODT once daily for 12 weeks, in the DBT phase. Participants were followed up for 8 weeks after last dose of study drug.

    Subject analysis set title
    DB Rimegepant/ Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received RMG 75 mg, ODT, once EOD alternating with matching placebo dosed EOD for 12 weeks in the DBT phase. Participants were followed up for 8 weeks after last dose of study drug.

    Subject analysis set title
    DB Rimegepant
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received RMG 75 mg ODT, once daily for 12 weeks in the DBT phase. Participants were followed up for 8 weeks after last dose of study drug.

    Subject analysis set title
    DB Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received matching placebo for RMG 75 mg ODT once daily for 12 weeks, in the DBT phase. Participants were followed up for 8 weeks after last dose of study drug.

    Subject analysis set title
    DB Rimegepant/ Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received RMG 75 mg, ODT, once EOD alternating with matching placebo dosed EOD for 12 weeks in the DBT phase. Participants were followed up for 8 weeks after last dose of study drug.

    Subject analysis set title
    DB Rimegepant
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received RMG 75 mg ODT, once daily for 12 weeks in the DBT phase. Participants were followed up for 8 weeks after last dose of study drug.

    Subject analysis set title
    DB Rimegepant/ Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received RMG 75 mg, ODT, once EOD alternating with matching placebo dosed EOD for 12 weeks in the DBT phase. Participants were followed up for 8 weeks after last dose of study drug.

    Subject analysis set title
    DB Rimegepant
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received RMG 75 mg ODT, once daily for 12 weeks in the DBT phase. Participants were followed up for 8 weeks after last dose of study drug.

    Subject analysis set title
    DB Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received matching placebo for RMG 75 mg ODT once daily for 12 weeks, in the DBT phase. Participants were followed up for 8 weeks after last dose of study drug.

    Subject analysis set title
    DB Rimegepant/ Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received RMG 75 mg, ODT, once EOD alternating with matching placebo dosed EOD for 12 weeks in the DBT phase. Participants were followed up for 8 weeks after last dose of study drug.

    Subject analysis set title
    DB Rimegepant
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received RMG 75 mg ODT, once daily for 12 weeks in the DBT phase. Participants were followed up for 8 weeks after last dose of study drug.

    Subject analysis set title
    DB Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received matching placebo for RMG 75 mg ODT once daily for 12 weeks, in the DBT phase. Participants were followed up for 8 weeks after last dose of study drug.

    Subject analysis set title
    DB RMG EOD/DB PBO EOD/ OL RMG QD
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants who received RMG 75 mg, ODT alternating with matching placebo in the DBT phase received RMG 75 mg ODT QD for 12 weeks in the OLE phase. Participants were followed up for 8 weeks after last dose of study drug.

    Subject analysis set title
    DB RMG QD/ OL RMG QD
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants who received RMG 75 mg ODT in the DBT phase continued to receive RMG 75 mg ODT once daily for 12 weeks in the OLE phase. Participants were followed up for 8 weeks after last dose of study drug.

    Subject analysis set title
    DB PBO QD/ OL RMG QD
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants who received placebo ODT in the DBT phase received RMG 75 mg ODT once daily for 12 weeks in the OLE phase. Participants were followed up for 8 weeks after last dose of study drug.

    Primary: Mean Change From Observation Phase (OP) in the Number of Migraine Days per Month Over Entire DBT Phase (Weeks 1 to 12)

    		Close Top of page
    End point title
    		 Mean Change From Observation Phase (OP) in the Number of Migraine Days per Month Over Entire DBT Phase (Weeks 1 to 12)
    End point description
    A migraine day:any calendar day in which participant experienced a qualified migraine headache.Qualified migraine headache:migraine with or without aura, lasting for >=30 minutes, and meeting either >=2 of the pain features:unilateral location;pulsating quality;moderate or severe pain intensity;aggravation by or causing avoidance of routine physical activity OR>=1 of associated symptoms:nausea and/or vomiting;photophobia and phonophobia.Number of migraine days per month were prorated to 28 days and derived for a month in on-DBT efficacy analysis period as follows:28*(total number of migraine days through Month 3 [Weeks1 to12]/(total number of e-diary efficacy data days through Month 3 [Weeks1 to12]). DB treatment efficacy (Migraine) set:participants in full analysis set who were randomized only once and took >=1 dose of DB study drug (rimegepant or placebo) and had>=14 days of eDiary efficacy data(not necessarily consecutive) in both the OP and >=1 month(4-week interval) in DBT Phase.
    End point type
    Primary
    End point timeframe
    Observation phase (from 31 days prior to randomization), DBT phase (through Month 3 [Week 1 to 12])
    End point values
    		 DB Rimegepant/ Placebo DB Rimegepant DB Placebo
    Number of subjects analysed
    221
    220
    224
    Units: Days per month
        least squares mean (confidence interval 97.5%)
    -2.9 (-3.31 to -2.42)
    -4.0 (-4.44 to -3.60)
    -2.2 (-2.65 to -1.85)
    Statistical analysis title
    		 DB Rimegepant/ Placebo vs DB Placebo
    Statistical analysis description
    Linear mixed effects model with repeated measures with the number of total migraine days per month in the OP as a covariate; treatment group, randomization stratum (use of previous prophylactic migraine medication generally considered to have efficacy), month and month-by-treatment group interaction as fixed effects.
    Comparison groups
    DB Rimegepant v DB Placebo
    Number of subjects included in analysis
    444
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -1.8
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -2.35
         upper limit
    		 -1.19
    Statistical analysis title
    		 DB Rimegepant/ Placebo vs DB Placebo
    Statistical analysis description
    Linear mixed effects model with repeated measures with the number of total migraine days per month in the OP as a covariate; treatment group, randomization stratum (use of previous prophylactic migraine medication generally considered to have efficacy), month and month-by-treatment group interaction as fixed effects.
    Comparison groups
    DB Rimegepant/ Placebo v DB Placebo
    Number of subjects included in analysis
    445
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.022
    Method
    		 Mixed models analysis
    Parameter type
    		 Least square mean (LSM) Difference
    Point estimate
    -0.6
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -1.22
         upper limit
    		 -0.01

    Secondary: Percentage of Participants With Greater Than Equal to (>=) 50 Percent (%) Reduction From OP in Number of Moderate to Severe Migraine Days per Month Over the Entire DBT Phase (Weeks 1 to 12)

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    End point title
    		 Percentage of Participants With Greater Than Equal to (>=) 50 Percent (%) Reduction From OP in Number of Moderate to Severe Migraine Days per Month Over the Entire DBT Phase (Weeks 1 to 12)
    End point description
    Percentage of participants with >= 50% reduction from OP, in number of migraine days (moderate or severe) in the overall DBT phase is reported in this outcome measure. The number of migraine days per month were prorated to 28 days and derived for a month in on-DBT efficacy analysis period as follows: 28*(total number of migraine days through Month 3 [Weeks 1 to 12]/ (total number of e-diary efficacy data days through Month 3 [Weeks 1 to 12]). Double-blind treatment efficacy (Migraine) analysis set included participants in the full analysis set who were randomized only once and took >= 1 dose of double-blind study drug (rimegepant or placebo) and had >=14 days of eDiary efficacy data (not necessarily consecutive) in both the OP and >=1 month (4-week interval) in the DBT Phase. Double-blind treatment efficacy (Migraine) analysis set was used.
    End point type
    Secondary
    End point timeframe
    DBT phase (through Month 3 [Week 1 to 12])
    End point values
    		 DB Rimegepant/ Placebo DB Rimegepant DB Placebo
    Number of subjects analysed
    221
    220
    224
    Units: Percentage of participants
        number (confidence interval 97.5%)
    42.5 (35.1 to 50.0)
    60.5 (53.1 to 67.8)
    34.4 (27.3 to 41.5)
    Statistical analysis title
    		 DB Rimegepant vs DB Placebo
    Statistical analysis description
    Mantel-Haenszel risk estimation was used.
    Comparison groups
    DB Rimegepant v DB Placebo
    Number of subjects included in analysis
    444
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    26.1
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 15.8
         upper limit
    		 36.3
    Statistical analysis title
    		 DB Rimegepant/ Placebo vs DB Placebo
    Statistical analysis description
    Mantel-Haenszel risk estimation was used.
    Comparison groups
    DB Rimegepant/ Placebo v DB Placebo
    Number of subjects included in analysis
    445
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0659
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    8.4
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 18.7

    Secondary: Mean Change From OP in the Number of Migraine Days per Month in the Last 4 Weeks (Weeks 9 to 12) of DBT Phase

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    End point title
    		 Mean Change From OP in the Number of Migraine Days per Month in the Last 4 Weeks (Weeks 9 to 12) of DBT Phase
    End point description
    Migraine day:any calendar day in which participant experienced a qualified migraine headache (onset,continuation,or recurrence of migraine headache).A qualified migraine headache:a migraine with or without aura, lasting for>=30 minutes,and meeting either>=2 of pain features:unilateral location;pulsating quality;moderate or severe pain intensity;aggravation by or causing avoidance of routine physical activity OR >=1 of associated symptoms:nausea and/or vomiting;photophobia and phonophobia. Number of migraine days per month were prorated to 28 days and derived a month (i.e.,4-week interval) in on-DBT efficacy analysis period as follows: 28*(total number of migraine days in month)/(total number of e-diary efficacy data in month). Mean change in number of migraine days per month in last 4 weeks of DBT phase as compared to OP phase was calculated and reported in this endpoint. DB treatment efficacy (Migraine) analysis set.
    End point type
    Secondary
    End point timeframe
    Observation phase (from 31 days before randomization), Week 9 to Week 12 of the DBT phase
    End point values
    		 DB Rimegepant/ Placebo DB Rimegepant DB Placebo
    Number of subjects analysed
    221
    220
    224
    Units: Days per month
        least squares mean (confidence interval 97.5%)
    -3.0 (-3.59 to -2.49)
    -4.2 (-4.75 to -3.75)
    -2.8 (-3.33 to -2.33)
    Statistical analysis title
    		 DB Rimegepant vs DB Placebo
    Statistical analysis description
    Linear mixed effects model with repeated measures with the number of total migraine days per month in the OP as a covariate; treatment group, randomization stratum (use of previous prophylactic migraine medication generally considered to have efficacy) month and month-by-treatment group interaction as fixed effects.
    Comparison groups
    DB Rimegepant v DB Placebo
    Number of subjects included in analysis
    444
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.4
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -2.12
         upper limit
    		 -0.71
    Statistical analysis title
    		 DB Rimegepant/ Placebo vs DB Placebo
    Statistical analysis description
    Linear mixed effects model with repeated measures with the number of total migraine days per month in the OP as a covariate; treatment group, randomization stratum (use of previous prophylactic migraine medication generally considered to have efficacy) month and month-by-treatment group interaction as fixed effects.
    Comparison groups
    DB Rimegepant/ Placebo v DB Placebo
    Number of subjects included in analysis
    445
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5314
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.2
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -0.95
         upper limit
    		 0.54

    Secondary: Mean Change From OP in the Number of Migraine Days per Month in the First 4 Weeks (Weeks 1 to 4) of DBT Phase

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    End point title
    		 Mean Change From OP in the Number of Migraine Days per Month in the First 4 Weeks (Weeks 1 to 4) of DBT Phase
    End point description
    A migraine day:any calendar day in which participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache: as a migraine with or without aura, lasting for >=30 minutes, and meeting either >=2 of the pain features:unilateral location;pulsating quality moderate or severe pain intensity;aggravation by or causing avoidance of routine physical activity OR >=1 of the associated symptoms:nausea and/or vomiting;photophobia and phonophobia. Number of migraine days per month were prorated to 28 days and derived a month (i.e., 4-week interval) in on-DBT efficacy analysis period as follows: 28*(total number of migraine days in the month / (total number of e-diary efficacy data in the month. Mean change in number of migraine days per month in the first 4 weeks of DBT phase as compared to OP phase was calculated and reported in this endpoint. Double-blind treatment efficacy (Migraine) analysis set was used.
    End point type
    Secondary
    End point timeframe
    Observation phase (from 31 days before randomization), Week 1 to Week 4 of the DBT phase
    End point values
    		 DB Placebo DB Rimegepant/ Placebo DB Rimegepant
    Number of subjects analysed
    224
    221
    220
    Units: Days per month
        least squares mean (confidence interval 97.5%)
    -1.5 (-1.97 to -1.05)
    -2.7 (-3.17 to -2.16)
    -3.6 (-4.10 to -3.16)
    Statistical analysis title
    		 DB Rimegepant vs DB Placebo
    Statistical analysis description
    Linear mixed effects model with repeated measures with the number of total migraine days per month in the OP as a covariate; treatment group, randomization stratum (use of previous prophylactic migraine medication generally considered to have efficacy) month and month-by-treatment group interaction as fixed effects.
    Comparison groups
    DB Rimegepant v DB Placebo
    Number of subjects included in analysis
    444
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -2.1
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -2.78
         upper limit
    		 -1.46
    Statistical analysis title
    		 DB Rimegepant/ Placebo vs DB Placebo
    Statistical analysis description
    Linear mixed effects model with repeated measures with the number of total migraine days per month in the OP as a covariate; treatment group, randomization stratum (use of previous prophylactic migraine medication generally considered to have efficacy) month and month-by-treatment group interaction as fixed effects.
    Comparison groups
    DB Rimegepant/ Placebo v DB Placebo
    Number of subjects included in analysis
    445
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0002
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.2
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -1.84
         upper limit
    		 -0.47

    Secondary: Mean Number of Acute Migraine-Specific Medication Days per Month Over the Entire DBT Phase (Weeks 1 to 12)

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    End point title
    		 Mean Number of Acute Migraine-Specific Medication Days per Month Over the Entire DBT Phase (Weeks 1 to 12)
    End point description
    An acute migraine-specific medication day was defined as any calendar day during which the participant took a migraine-specific medication (i.e., triptan or ergotamine). The number of acute migraine-specific medication days per month were prorated to 28 days and derived for on-DBT efficacy analysis period as follows: 28*(total number of acute migraine-specific medication days through Month 3/ (total number of e-Diary efficacy data days through Month 3). Double-blind treatment efficacy (Migraine) analysis set included participants in the full analysis set who were randomized only once and took >= 1 dose of double-blind study drug (rimegepant or placebo) and had >=14 days of eDiary efficacy data (not necessarily consecutive) in both the OP and >=1 month (4-week interval) in the DBT Phase.
    End point type
    Secondary
    End point timeframe
    DBT phase (through Month 3 [Week 1 to 12])
    End point values
    		 DB Rimegepant/ Placebo DB Rimegepant DB Placebo
    Number of subjects analysed
    221
    220
    224
    Units: Days per month
        least squares mean (confidence interval 97.5%)
    2.3 (1.87 to 2.82)
    1.5 (1.13 to 1.88)
    2.8 (2.28 to 3.35)
    Statistical analysis title
    		 DB Rimegepant vs DB Placebo
    Statistical analysis description
    Linear mixed effects model with repeated measures has treatment group, randomization stratum, month, and month-by-treatment group interaction as fixed effects.
    Comparison groups
    DB Rimegepant v DB Placebo
    Number of subjects included in analysis
    444
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.3
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -1.97
         upper limit
    		 -0.65
    Statistical analysis title
    		 DB Rimegepant/ Placebo vs DB Placebo
    Statistical analysis description
    Linear mixed effects model with repeated measures has treatment group, randomization stratum, month, and month-by-treatment group interaction as fixed effects.
    Comparison groups
    DB Rimegepant/ Placebo v DB Placebo
    Number of subjects included in analysis
    445
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.144
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.5
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 0.25

    Secondary: Mean Change From Baseline in the Migraine-Specific Quality-of-Life Questionnaire (MSQoL) Version 2.1 Restrictive Role Function Domain Score at Week 12 of the DBT Phase

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    End point title
    		 Mean Change From Baseline in the Migraine-Specific Quality-of-Life Questionnaire (MSQoL) Version 2.1 Restrictive Role Function Domain Score at Week 12 of the DBT Phase
    End point description
    MSQoL is a self-administered, 14-item instrument validated in 3 domains:role restriction, prevention, and emotional function. Restrictive role function domain consisted of 7 items that described how migraine limited one’s daily social and work-related activities. Participants were required to respond to items using a 6-point scale ranging from 1 to 6, where 1:none of the time, 2: a little bit of time,” “3: some of time,4: a good bit of time, 5: most of time, and 6: all of time. Item scores were recoded using (7 -original score). Raw dimension scores for restrictive role function domain were computed as a sum of recoded item scores and rescaled from a 0 to 100 scale such that lower score (0) indicated poor quality of life and higher scores (100) better quality of life. DB treatment efficacy analysis set included participants in the full analysis set who were randomized only once and took >= 1 dose of double-blind study drug. Here “N”:number of participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 12 of the DBT phase
    End point values
    		 DB Rimegepant/ Placebo DB Rimegepant DB Placebo
    Number of subjects analysed
    194
    191
    197
    Units: Units on a scale
        least squares mean (confidence interval 97.5%)
    21.3 (18.37 to 24.33)
    29.1 (25.79 to 32.31)
    18.9 (15.91 to 21.97)
    Statistical analysis title
    		 DB Rimegepant vs DB Placebo
    Statistical analysis description
    Linear regression model with treatment group and randomization stratum as fixed effects and baseline score as covariate for participants with non-missing domain scores at both baseline and Week 12.
    Comparison groups
    DB Rimegepant v DB Placebo
    Number of subjects included in analysis
    388
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean Difference
    Point estimate
    10.1
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 5.71
         upper limit
    		 14.52
    Statistical analysis title
    		 DB Rimegepant/ Placebo vs DB Placebo
    Statistical analysis description
    Linear regression model with treatment group and randomization stratum as fixed effects and baseline score as covariate for participants with non-missing domain scores at both baseline and Week 12.
    Comparison groups
    DB Rimegepant/ Placebo v DB Placebo
    Number of subjects included in analysis
    391
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2029
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean Difference
    Point estimate
    2.4
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -1.84
         upper limit
    		 6.66

    Secondary: Number of Participants With Mild, Moderate and Severe Adverse Events (AEs) in DBT Phase

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    End point title
    		 Number of Participants With Mild, Moderate and Severe Adverse Events (AEs) in DBT Phase
    End point description
    An AE:any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. AEs were categorized as mild:usually transient and required only minimal treatment or therapeutic intervention. event did not generally interfere with usual activities of daily living. Moderate:was usually alleviated with additional specific therapeutic intervention.event interfered with usual activities of daily living,causing discomfort but posed no significant or permanent risk of harm to participant. Severe:Interrupted usual activities of daily living, significantly affected clinical status, or required intensive therapeutic intervention. AEs included non-SAEs and SAEs. DB treatment safety population included participants in the enrolled analysis set who took >=1 dose of DB study drug (rimegepant or placebo).
    End point type
    Secondary
    End point timeframe
    DBT: From Week 1 to Week 20
    End point values
    		 DB Rimegepant/ Placebo DB Rimegepant DB Placebo
    Number of subjects analysed
    232
    229
    231
    Units: Participants
        Mild
    73
    86
    91
        Moderate
    42
    22
    43
        Severe
    4
    3
    2
    No statistical analyses for this end point

    Secondary: Number of Participants With Mild, Moderate and Severe AEs OLE Phase

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    End point title
    		 Number of Participants With Mild, Moderate and Severe AEs OLE Phase
    End point description
    An AE: any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. AEs were categorized as mild: usually transient and required only minimal treatment or therapeutic intervention. The event did not generally interfere with usual activities of daily living. Moderate: was usually alleviated with additional specific therapeutic intervention. The event interfered with usual activities of daily living, causing discomfort but posed no significant or permanent risk of harm to the participant. Severe: Interrupted usual activities of daily living, significantly affected clinical status, or required intensive therapeutic intervention. AEs included both non-SAEs and SAEs. OL rimegepant safety population included participants in the enrolled analysis set who took >= 1 dose of OL rimegepant.
    End point type
    Secondary
    End point timeframe
    OLE: From Week 12 to Week 32
    End point values
    		 DB RMG EOD/DB PBO EOD/ OL RMG QD DB RMG QD/ OL RMG QD DB PBO QD/ OL RMG QD
    Number of subjects analysed
    182
    196
    195
    Units: Participants
        Mild
    65
    57
    65
        Moderate
    30
    22
    25
        Severe
    2
    2
    1
    No statistical analyses for this end point

    Secondary: Number of Participants With Serious Adverse Events (SAEs) in DBT Phase

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    End point title
    		 Number of Participants With Serious Adverse Events (SAEs) in DBT Phase
    End point description
    An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. An SAE was any event that met any of the following criteria at any dose: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of the participant who received rimegepant and other important medical events. Double-blind treatment safety population included participants in the enrolled analysis set who took >= 1 dose of double-blind study drug (rimegepant or placebo).
    End point type
    Secondary
    End point timeframe
    DBT: From Week 1 to Week 20
    End point values
    		 DB Rimegepant/ Placebo DB Rimegepant DB Placebo
    Number of subjects analysed
    232
    229
    231
    Units: Participants
    3
    2
    1
    No statistical analyses for this end point

    Secondary: Number of Participants With SAEs in OLE Phase

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    End point title
    		 Number of Participants With SAEs in OLE Phase
    End point description
    An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. An SAE was any event that met any of the following criteria at any dose: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of the participant who received rimegepant and other important medical events. Open-label rimegepant safety population included participants in the enrolled analysis set who took >= 1 dose of open-label rimegepant.
    End point type
    Secondary
    End point timeframe
    OLE: From Week 12 to Week 32
    End point values
    		 DB RMG EOD/DB PBO EOD/ OL RMG QD DB RMG QD/ OL RMG QD DB PBO QD/ OL RMG QD
    Number of subjects analysed
    182
    196
    195
    Units: Participants
    2
    2
    2
    No statistical analyses for this end point

    Secondary: Number of Participants With AEs Leading to Study Drug Discontinuation in OLE Phase

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    End point title
    		 Number of Participants With AEs Leading to Study Drug Discontinuation in OLE Phase
    End point description
    An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. In this outcome measure, participants with adverse events leading to study drug discontinuation were reported. Open-label rimegepant safety population included participants in the enrolled analysis set who took >= 1 dose of open-label rimegepant.
    End point type
    Secondary
    End point timeframe
    OLE: From Week 12 to Week 24
    End point values
    		 DB RMG EOD/DB PBO EOD/ OL RMG QD DB RMG QD/ OL RMG QD DB PBO QD/ OL RMG QD
    Number of subjects analysed
    182
    196
    195
    Units: Participants
    4
    1
    1
    No statistical analyses for this end point

    Secondary: Number of Participants With AEs Leading to Study Drug Discontinuation in DBT Phase

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    End point title
    		 Number of Participants With AEs Leading to Study Drug Discontinuation in DBT Phase
    End point description
    An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. In this outcome measure, participants with adverse events leading to study drug discontinuation were reported. Double-blind treatment safety population included participants in the enrolled analysis set who took >= 1 dose of double-blind study drug (rimegepant or placebo).
    End point type
    Secondary
    End point timeframe
    DBT: From Week 1 to Week 12
    End point values
    		 DB Rimegepant/ Placebo DB Rimegepant DB Placebo
    Number of subjects analysed
    232
    229
    231
    Units: Participants
    6
    1
    4
    No statistical analyses for this end point

    Secondary: Number of Participants With Grade 3 to 4 Laboratory Abnormalities in DBT Phase

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    End point title
    		 Number of Participants With Grade 3 to 4 Laboratory Abnormalities in DBT Phase
    End point description
    Laboratory parameters were graded according to National Cancer Institute(NCI)common terminology criteria for AE(CTCAE) version 5.0 and using division of AIDS (DAIDS) toxicity grading scale version 2.1 (glucose,low density lipoprotein [LDL] cholesterol,uric acid and urinalysis) and for other parameters (eosinophils,hemoglobin,leukocytes,albumin,lymphocytes, neutrophils,platelets,alanine aminotransferase,alkaline phosphatase ,aspartate aminotransferase,bicarbonate,bilirubin,calcium, cholesterol,creatine kinase,creatinine,Lactate dehydrogenase, potassium,sodium,triglycerides)CTCAE v5.0 was used.Severity were graded as Grade1=mild AE,G2=moderate,G3=severe,G4=life-threatening consequences;urgent intervention indicated.Only laboratory abnormalities with non-zero values in any of treatment are reported.DB treatment safety population.All participants under‘N’contributed data to table;however,may not have evaluable data for every row.Here“n”:number of participants evaluable for specified rows.
    End point type
    Secondary
    End point timeframe
    DBT: From Week 1 to Week 20
    End point values
    		 DB Rimegepant/ Placebo DB Rimegepant DB Placebo
    Number of subjects analysed
    232
    229
    231
    Units: Participants
        Lymphocytes, low(n:225,224,224)
    0
    0
    1
        Alanine Aminotransferase(n:225,224,225)
    0
    1
    1
        Aspartate Aminotransferase (n:225,224,225)
    0
    0
    1
        Creatine Kinase(n:225,224,225)
    2
    1
    4
        Glucose, low(n:225,224,225)
    0
    1
    0
        LDL Cholesterol(n:207,213,218)
    6
    4
    9
        LDL Cholesterol, fasting(n:107,120,118)
    4
    3
    3
        LDL Cholesterol, not fasting(n:102,96,102)
    2
    1
    6
        Sodium, high(n:225,224,225)
    0
    0
    1
        Triglycerides(n:207,213,218)
    0
    1
    0
        Triglycerides, fasting(n:107,120,118)
    0
    1
    0
        Urinalysis Glucose(n:204,207,213)
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Grade 3 to 4 Laboratory Abnormalities in OLE Phase

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    End point title
    		 Number of Participants With Grade 3 to 4 Laboratory Abnormalities in OLE Phase
    End point description
    laboratory parameters were graded according to the NCI CTCAE version 5.0 and using DAIDS toxicity grading scale version 2.1 (glucose, LDL cholesterol, uric acid and urinalysis). And for other parameters (eosinophils,hemoglobin,leukocytes,albumin, lymphocytes,neutrophils,platelets,alanine aminotransferase,alkaline phosphatase,aspartate aminotransferase,bicarbonate,bilirubin, calcium,cholesterol,creatine kinase,creatinine, lactate dehydrogenase,potassium,sodium,triglycerides) CTCAE v5.0 was used. Severity was graded as Grade 1=mild AE, G 2=moderate, G3=severe,G4=life-threatening consequences; urgent intervention indicated. Number of participants according to Grade 3 or 4 laboratory abnormalities are reported. Only laboratory abnormalities with non-zero values in any of treatment arms are reported. OL treatment safety population.All participants under‘N’contributed data to table;however,may not have evaluable data for every row.Here“n”:number of participants evaluable for specified rows.
    End point type
    Secondary
    End point timeframe
    OLE: From Week 12 to Week 32
    End point values
    		 DB RMG EOD/DB PBO EOD/ OL RMG QD DB RMG QD/ OL RMG QD DB PBO QD/ OL RMG QD
    Number of subjects analysed
    182
    196
    195
    Units: Participants
        Alanine Aminotransferase(n:180,193,194)
    1
    1
    1
        Aspartate Aminotransferase(n:180,193,194)
    0
    1
    0
        Creatine Kinase(n:180,191,190)
    3
    0
    5
        LDL Cholesterol(n:166,182,179)
    7
    8
    4
        LDL Cholesterol, fasting(n:80,101,88)
    4
    4
    0
        LDL Cholesterol, not fasting(n:89,81,92)
    3
    4
    4
        Potassium, low(n:180,191,190)
    0
    1
    0
        Potassium, high(n:180,191,190)
    1
    0
    1
        Triglycerides(n:166,182,179)
    0
    1
    0
        Triglycerides, not fasting(n:89,81,92)
    0
    1
    0
        Urinalysis Glucose(n:162,176,175)
    1
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) Elevations > 3* Upper Limit of Normal (ULN) Concurrent With (Total Bilirubin) TBL >2*ULN in DBT Phase

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    End point title
    		 Number of Participants With Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) Elevations > 3* Upper Limit of Normal (ULN) Concurrent With (Total Bilirubin) TBL >2*ULN in DBT Phase
    End point description
    Number of participants with AST or ALT >3*ULN concurrent with TBL >2*ULN in DBT phase were reported in this endpoint. Double-blind treatment safety population included participants in the enrolled analysis set who took >= 1 dose of double-blind study drug (rimegepant or placebo). Here “Overall Number of Participants Analyzed” signifies the number of participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    DBT: From Week 1 to Week 20
    End point values
    		 DB Rimegepant/ Placebo DB Rimegepant DB Placebo
    Number of subjects analysed
    225
    224
    225
    Units: Participants
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With AST or ALT Elevations > 3* ULN Concurrent With TBL >2*ULN in OLE Phase

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    End point title
    		 Number of Participants With AST or ALT Elevations > 3* ULN Concurrent With TBL >2*ULN in OLE Phase
    End point description
    Number of participants with AST or ALT >3*ULN concurrent with TBL >2*ULN in DBT phase were reported in this endpoint. Open-label rimegepant safety population included participants in the enrolled analysis set who took >= 1 dose of open-label rimegepant. Here “Overall Number of Participants Analyzed” signifies the number of participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    OLE: From Week 12 to Week 32
    End point values
    		 DB RMG EOD/DB PBO EOD/ OL RMG QD DB RMG QD/ OL RMG QD DB PBO QD/ OL RMG QD
    Number of subjects analysed
    180
    193
    194
    Units: Participants
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Hepatic-Related AEs in the DBT Phase

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    End point title
    		 Number of Participants With Hepatic-Related AEs in the DBT Phase
    End point description
    An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. Hepatic-related AEs included: alanine aminotransferase and aspartate aminotransferase increased, liver function test abnormal, liver function test increased, bilirubin conjugated increased, blood bilirubin increased, transaminases increased and hyperbilirubinemia. Number of participants with any hepatic-related AEs in the DBT phase were reported in this endpoint measure. Double-blind treatment safety population included participants in the enrolled analysis set who took >= 1 dose of double-blind study drug (rimegepant or placebo).
    End point type
    Secondary
    End point timeframe
    DBT: From Week 1 to Week 20
    End point values
    		 DB Rimegepant/ Placebo DB Rimegepant DB Placebo
    Number of subjects analysed
    232
    229
    231
    Units: Participants
    7
    8
    8
    No statistical analyses for this end point

    Secondary: Number of Participants With Hepatic-Related AEs in the OLE Phase

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    End point title
    		 Number of Participants With Hepatic-Related AEs in the OLE Phase
    End point description
    An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. Hepatic AEs included: alanine aminotransferase and aspartate aminotransferase increased, liver function test abnormal, bilirubin conjugated, hepatic enzyme increased, blood bilirubin unconjugated increased, blood bilirubin and transaminases increased and hepatic function abnormal. Number of participants with any hepatic-related AEs in the OLE phase were reported in this endpoint measure. Open-label rimegepant safety population included participants in the enrolled analysis set who took >= 1 dose of open-label rimegepant.
    End point type
    Secondary
    End point timeframe
    OLE: From Week 12 to Week 32
    End point values
    		 DB RMG EOD/DB PBO EOD/ OL RMG QD DB RMG QD/ OL RMG QD DB PBO QD/ OL RMG QD
    Number of subjects analysed
    182
    196
    195
    Units: Participants
    11
    4
    6
    No statistical analyses for this end point

    Secondary: Number of Participants With Hepatic-Related AEs Leading to Study Drug Discontinuation in the DBT Phase

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    End point title
    		 Number of Participants With Hepatic-Related AEs Leading to Study Drug Discontinuation in the DBT Phase
    End point description
    An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. Hepatic-related AEs included: alanine aminotransferase and aspartate aminotransferase increased, liver function test and blood bilirubin increased. Number of participants with any hepatic-related AEs leading to study drug discontinuation is reported in this endpoint measure. Double-blind treatment safety population included participants in the enrolled analysis set who took >= 1 dose of double-blind study drug (rimegepant or placebo).
    End point type
    Secondary
    End point timeframe
    DBT: From Week 1 to Week 12
    End point values
    		 DB Rimegepant/ Placebo DB Rimegepant DB Placebo
    Number of subjects analysed
    232
    229
    231
    Units: Participants
    4
    1
    2
    No statistical analyses for this end point

    Secondary: Number of Participants With Hepatic-Related AEs Leading to Study Drug Discontinuation in the OLE Phase

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    End point title
    		 Number of Participants With Hepatic-Related AEs Leading to Study Drug Discontinuation in the OLE Phase
    End point description
    An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. Hepatic-related AEs included: aspartate aminotransferase increased and liver function test abnormal. Number of participants with any hepatic-related AEs leading to study drug discontinuation is reported in this endpoint measure. Open-label rimegepant safety population included participants in the enrolled analysis set who took >= 1 dose of open-label rimegepant.
    End point type
    Secondary
    End point timeframe
    OLE: From Week 12 to Week 24
    End point values
    		 DB RMG EOD/DB PBO EOD/ OL RMG QD DB RMG QD/ OL RMG QD DB PBO QD/ OL RMG QD
    Number of subjects analysed
    182
    196
    195
    Units: Participants
    1
    1
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 8 weeks after last dose of study drug (DBT phase: Week 1 to Week 20; OLE phase Week 12 to Week 32)
    Adverse event reporting additional description
    Same event may appear as AE and SAE,but what is presented are distinct events. Event may be categorized as serious in 1 and non-SAE in another participant, or 1 participant may have experienced both.DB and OL RMG treatment safety population=participants in the enrolled analysis set who took>=1 dose of DB/OL-RMG study drug used for DBT and OL RMG.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    v27.1
    Reporting groups
    Reporting group title
    DB Rimegepant/ Placebo
    Reporting group description
    		 Participants received RMG 75 mg, ODT, once EOD alternating with matching placebo dosed EOD for 12 weeks in the DBT phase. Participants were followed up for 8 weeks after last dose of study drug.

    Reporting group title
    DB Rimegepant
    Reporting group description
    		 Participants received RMG 75 mg ODT, once daily for 12 weeks in the DBT phase. Participants were followed up for 8 weeks after last dose of study drug.

    Reporting group title
    DB Placebo
    Reporting group description
    		 Participants received matching placebo for RMG 75 mg ODT once daily for 12 weeks, in the DBT phase. Participants were followed up for 8 weeks after last dose of study drug.

    Reporting group title
    DB RMG EOD/DB PBO EOD/ OL RMG QD
    Reporting group description
    		 Participants who received RMG 75 mg, ODT alternating with matching placebo in the DBT phase received RMG 75 mg ODT QD for 12 weeks in the OLE phase. Participants were followed up for 8 weeks after last dose of study drug.

    Reporting group title
    DB RMG QD/ OL RMG QD
    Reporting group description
    		 Participants who received RMG 75 mg ODT in the DBT phase continued to receive RMG 75 mg ODT once daily for 12 weeks in the OLE phase. Participants were followed up for 8 weeks after last dose of study drug.

    Reporting group title
    DB PBO QD/ OL RMG QD
    Reporting group description
    		 Participants who received placebo ODT in the DBT phase received RMG 75 mg ODT once daily for 12 weeks in the OLE phase. Participants were followed up for 8 weeks after last dose of study drug.

    Serious adverse events
    		 DB Rimegepant/ Placebo DB Rimegepant DB Placebo DB RMG EOD/DB PBO EOD/ OL RMG QD DB RMG QD/ OL RMG QD DB PBO QD/ OL RMG QD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 232 (1.29%)
    2 / 229 (0.87%)
    1 / 231 (0.43%)
    2 / 182 (1.10%)
    2 / 196 (1.02%)
    2 / 195 (1.03%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Investigations
    Liver function test abnormal
         subjects affected / exposed
    0 / 232 (0.00%)
    0 / 229 (0.00%)
    0 / 231 (0.00%)
    0 / 182 (0.00%)
    1 / 196 (0.51%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Oesophageal carcinoma
         subjects affected / exposed
    1 / 232 (0.43%)
    0 / 229 (0.00%)
    0 / 231 (0.00%)
    0 / 182 (0.00%)
    0 / 196 (0.00%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 232 (0.00%)
    0 / 229 (0.00%)
    0 / 231 (0.00%)
    0 / 182 (0.00%)
    0 / 196 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Status migrainosus
         subjects affected / exposed
    1 / 232 (0.43%)
    0 / 229 (0.00%)
    0 / 231 (0.00%)
    1 / 182 (0.55%)
    0 / 196 (0.00%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Crohn\'s disease
         subjects affected / exposed
    1 / 232 (0.43%)
    0 / 229 (0.00%)
    0 / 231 (0.00%)
    0 / 182 (0.00%)
    0 / 196 (0.00%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 232 (0.00%)
    0 / 229 (0.00%)
    0 / 231 (0.00%)
    1 / 182 (0.55%)
    0 / 196 (0.00%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Costochondritis
         subjects affected / exposed
    0 / 232 (0.00%)
    0 / 229 (0.00%)
    0 / 231 (0.00%)
    0 / 182 (0.00%)
    1 / 196 (0.51%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 232 (0.00%)
    0 / 229 (0.00%)
    0 / 231 (0.00%)
    0 / 182 (0.00%)
    0 / 196 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 232 (0.00%)
    0 / 229 (0.00%)
    1 / 231 (0.43%)
    0 / 182 (0.00%)
    0 / 196 (0.00%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infected cyst
         subjects affected / exposed
    0 / 232 (0.00%)
    1 / 229 (0.44%)
    0 / 231 (0.00%)
    0 / 182 (0.00%)
    0 / 196 (0.00%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 232 (0.00%)
    1 / 229 (0.44%)
    0 / 231 (0.00%)
    0 / 182 (0.00%)
    0 / 196 (0.00%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 DB Rimegepant/ Placebo DB Rimegepant DB Placebo DB RMG EOD/DB PBO EOD/ OL RMG QD DB RMG QD/ OL RMG QD DB PBO QD/ OL RMG QD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 232 (5.60%)
    13 / 229 (5.68%)
    13 / 231 (5.63%)
    17 / 182 (9.34%)
    19 / 196 (9.69%)
    13 / 195 (6.67%)
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 232 (0.00%)
    0 / 229 (0.00%)
    0 / 231 (0.00%)
    4 / 182 (2.20%)
    14 / 196 (7.14%)
    6 / 195 (3.08%)
         occurrences all number
    0
    0
    0
    4
    14
    6
    Nasopharyngitis
         subjects affected / exposed
    13 / 232 (5.60%)
    13 / 229 (5.68%)
    13 / 231 (5.63%)
    13 / 182 (7.14%)
    5 / 196 (2.55%)
    7 / 195 (3.59%)
         occurrences all number
    14
    14
    16
    14
    6
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Jan 2022
    Amendment 2: The purpose of the amendment was to update the schedule of assessments, inclusion and exclusion criteria.
    17 Mar 2022
    Amendment 3: The purpose of the amendment was to update the schedule of assessments, clarified restrictions around prohibited medication use, to clarified HbA1c collection and analysis sets.
    01 Jul 2022
    Amendment 4: The purpose of the amendment was to update the exclusion criterion, clarified low dose aspirin use for cardiovascular prophylaxis and clarified the definition of the “Migraine” analysis set.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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