Trial Outcomes & Findings for Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens (NCT NCT05217927)
NCT ID: NCT05217927
Last Updated: 2025-12-16
Results Overview
A migraine day was defined as any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined 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. 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 \[Weeks 1 to 12\]). Mean change in number of migraine days per month in DBT phase as compared to OP phase was calculated and reported in this outcome measure.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1415 participants
Primary outcome timeframe
Observation phase (from 31 days prior to randomization), DBT phase (through Month 3 [Week 1 to 12])
Results posted on
2025-12-16
Participant Flow
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 participants received the study intervention.
Participant milestones
| Measure |
Double Blind (DB) Rimegepant/ Placebo/ Open Label (OL) Rimegepant
Participants received rimegepant (RMG) 75 mg, orally disintegrating tablets (ODT), once every other day (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.
|
DB Rimegepant/OL Rimegepant
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.
|
DB Placebo/OL Rimegepant
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.
|
|---|---|---|---|
|
DBT Phase
STARTED
|
234
|
232
|
233
|
|
DBT Phase
Treated
|
232
|
229
|
231
|
|
DBT Phase
COMPLETED
|
204
|
209
|
208
|
|
DBT Phase
NOT COMPLETED
|
30
|
23
|
25
|
|
OLE Phase
STARTED
|
182
|
196
|
195
|
|
OLE Phase
COMPLETED
|
170
|
187
|
183
|
|
OLE Phase
NOT COMPLETED
|
12
|
9
|
12
|
Reasons for withdrawal
| Measure |
Double Blind (DB) Rimegepant/ Placebo/ Open Label (OL) Rimegepant
Participants received rimegepant (RMG) 75 mg, orally disintegrating tablets (ODT), once every other day (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.
|
DB Rimegepant/OL Rimegepant
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.
|
DB Placebo/OL Rimegepant
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.
|
|---|---|---|---|
|
DBT Phase
Adverse Event
|
7
|
2
|
5
|
|
DBT Phase
Lack of Efficacy
|
1
|
0
|
0
|
|
DBT Phase
Lost to Follow-up
|
0
|
2
|
0
|
|
DBT Phase
Non-compliance
|
1
|
0
|
0
|
|
DBT Phase
Pregnancy
|
0
|
0
|
1
|
|
DBT Phase
Protocol Violation
|
0
|
2
|
1
|
|
DBT Phase
Protocol-specified withdrawal criterion met
|
4
|
6
|
5
|
|
DBT Phase
Withdrawal of consent
|
8
|
5
|
7
|
|
DBT Phase
Other
|
7
|
3
|
4
|
|
DBT Phase
Randomized, not treated
|
2
|
3
|
2
|
|
OLE Phase
Adverse Event
|
4
|
1
|
1
|
|
OLE Phase
Extension phase eligibility failure
|
1
|
0
|
0
|
|
OLE Phase
Lost to Follow-up
|
1
|
2
|
1
|
|
OLE Phase
Non-compliance
|
0
|
0
|
1
|
|
OLE Phase
Other
|
3
|
5
|
4
|
|
OLE Phase
Withdrawal of consent
|
3
|
1
|
5
|
Baseline Characteristics
Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
Baseline characteristics by cohort
| Measure |
DB Rimegepant/OL Rimegepant
n=229 Participants
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.
|
DB Placebo/OL Rimegepant
n=231 Participants
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.
|
Total
n=692 Participants
Total of all reporting groups
|
DB Rimegepant/ Placebo/ OL Rimegepant
n=232 Participants
Participants received RMG 75 mg ODT, EOD alternating with matching placebo dosed EOD for 12 weeks in the DBT phase. Eligible participants received RMG 75 mg ODT QD for 12 weeks in OLE phase. Participants were followed up for 8 weeks after last dose of study drug.
|
|---|---|---|---|---|
|
Age, Continuous
|
43.9 Years
STANDARD_DEVIATION 12.05 • n=229 Participants
|
42.9 Years
STANDARD_DEVIATION 12.35 • n=231 Participants
|
43 Years
STANDARD_DEVIATION 12.13 • n=692 Participants
|
42.0 Years
STANDARD_DEVIATION 11.96 • n=232 Participants
|
|
Sex: Female, Male
Female
|
192 Participants
n=229 Participants
|
207 Participants
n=231 Participants
|
600 Participants
n=692 Participants
|
201 Participants
n=232 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=229 Participants
|
24 Participants
n=231 Participants
|
92 Participants
n=692 Participants
|
31 Participants
n=232 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=70 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
25 Participants
n=76 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
68 Participants
n=216 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
23 Participants
n=70 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=70 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
51 Participants
n=76 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
148 Participants
n=216 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
47 Participants
n=70 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=70 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
0 Participants
n=76 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
0 Participants
n=216 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
0 Participants
n=70 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=70 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
0 Participants
n=76 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
1 Participants
n=216 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
1 Participants
n=70 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=70 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
6 Participants
n=76 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
12 Participants
n=216 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
5 Participants
n=70 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=70 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
1 Participants
n=76 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
2 Participants
n=216 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
1 Participants
n=70 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=70 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
6 Participants
n=76 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
24 Participants
n=216 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
6 Participants
n=70 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
|
Race (NIH/OMB)
White
|
56 Participants
n=70 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
63 Participants
n=76 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
175 Participants
n=216 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
56 Participants
n=70 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=70 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
0 Participants
n=76 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
1 Participants
n=216 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
0 Participants
n=70 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=70 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
0 Participants
n=76 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
1 Participants
n=216 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
1 Participants
n=70 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
PRIMARY outcome
Timeframe: Observation phase (from 31 days prior to randomization), DBT phase (through Month 3 [Week 1 to 12])Population: 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.
A migraine day was defined as any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined 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. 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 \[Weeks 1 to 12\]). Mean change in number of migraine days per month in DBT phase as compared to OP phase was calculated and reported in this outcome measure.
Outcome measures
| Measure |
DB Rimegepant/ Placebo
n=221 Participants
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.
|
DB Rimegepant
n=220 Participants
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.
|
DB Placebo
n=224 Participants
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.
|
|---|---|---|---|
|
Mean Change From Observation Phase (OP) in the Number of Migraine Days Per Month Over Entire DBT Phase (Weeks 1 to 12)
|
-2.9 Days per month
Interval -3.31 to -2.42
|
-4.0 Days per month
Interval -4.44 to -3.6
|
-2.2 Days per month
Interval -2.65 to -1.85
|
SECONDARY outcome
Timeframe: DBT phase (through Month 3 [Week 1 to 12])Population: 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.
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 \[Weeks 1 to 12\]).
Outcome measures
| Measure |
DB Rimegepant/ Placebo
n=221 Participants
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.
|
DB Rimegepant
n=220 Participants
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.
|
DB Placebo
n=224 Participants
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.
|
|---|---|---|---|
|
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)
|
40.5 Percentage of participants
Interval 33.5 to 47.9
|
58.1 Percentage of participants
Interval 50.7 to 65.3
|
33.3 Percentage of participants
Interval 26.4 to 40.2
|
SECONDARY outcome
Timeframe: Observation phase (from 31 days before randomization), Week 9 to Week 12 of the DBT phasePopulation: 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. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.
A migraine day was defined as any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined 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. The 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 last 4 weeks of DBT phase as compared to OP phase was calculated and reported in this outcome measure.
Outcome measures
| Measure |
DB Rimegepant/ Placebo
n=203 Participants
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.
|
DB Rimegepant
n=206 Participants
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.
|
DB Placebo
n=209 Participants
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.
|
|---|---|---|---|
|
Mean Change From OP in the Number of Migraine Days Per Month in the Last 4 Weeks (Weeks 9 to 12) of DBT Phase
|
-3.0 Days per month
Interval -3.59 to -2.49
|
-4.2 Days per month
Interval -4.75 to -3.75
|
-2.8 Days per month
Interval -3.33 to -2.33
|
SECONDARY outcome
Timeframe: Observation phase (from 31 days before randomization), Week 1 to Week 4 of the DBT phasePopulation: 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. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.
A migraine day was defined as any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined 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. The 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 outcome measure.
Outcome measures
| Measure |
DB Rimegepant/ Placebo
n=220 Participants
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.
|
DB Rimegepant
n=219 Participants
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.
|
DB Placebo
n=224 Participants
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.
|
|---|---|---|---|
|
Mean Change From OP in the Number of Migraine Days Per Month in the First 4 Weeks (Weeks 1 to 4) of DBT Phase
|
-2.7 Days per month
Interval -3.17 to -2.16
|
-3.6 Days per month
Interval -4.1 to -3.16
|
-1.5 Days per month
Interval -1.97 to -1.05
|
SECONDARY outcome
Timeframe: DBT phase (through Month 3 [Week 1 to 12])Population: 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.
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).
Outcome measures
| Measure |
DB Rimegepant/ Placebo
n=221 Participants
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.
|
DB Rimegepant
n=220 Participants
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.
|
DB Placebo
n=224 Participants
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.
|
|---|---|---|---|
|
Mean Number of Acute Migraine-Specific Medication Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)
|
2.3 Days per month
Interval 1.87 to 2.82
|
1.5 Days per month
Interval 1.13 to 1.88
|
2.8 Days per month
Interval 2.28 to 3.35
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 12 of the DBT phasePopulation: Double-blind 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 "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.
MSQoL is a self-administered, 14-item instrument validated in 3 domains: role restriction, role prevention, and the emotional function. The 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 the time," "3: some of the time," "4: a good bit of the time," "5: most of the time," and "6: all of the 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) indicated better quality of life.
Outcome measures
| Measure |
DB Rimegepant/ Placebo
n=194 Participants
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.
|
DB Rimegepant
n=191 Participants
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.
|
DB Placebo
n=197 Participants
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.
|
|---|---|---|---|
|
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
|
21.3 Units on a scale
Interval 18.37 to 24.33
|
29.1 Units on a scale
Interval 25.79 to 32.31
|
18.9 Units on a scale
Interval 15.91 to 21.97
|
SECONDARY outcome
Timeframe: DBT: From Week 1 to Week 20Population: Double-blind treatment safety population included participants in the enrolled analysis set who took \>= 1 dose of double-blind study drug (rimegepant or placebo).
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. 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 serious adverse events (SAEs).
Outcome measures
| Measure |
DB Rimegepant/ Placebo
n=232 Participants
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.
|
DB Rimegepant
n=229 Participants
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.
|
DB Placebo
n=231 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Mild, Moderate and Severe Adverse Events (AEs) in DBT Phase
Mild
|
73 Participants
|
86 Participants
|
91 Participants
|
|
Number of Participants With Mild, Moderate and Severe Adverse Events (AEs) in DBT Phase
Moderate
|
42 Participants
|
22 Participants
|
43 Participants
|
|
Number of Participants With Mild, Moderate and Severe Adverse Events (AEs) in DBT Phase
Severe
|
4 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: OLE: From Week 12 to Week 32Population: Open-label rimegepant safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
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. 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.
Outcome measures
| Measure |
DB Rimegepant/ Placebo
n=182 Participants
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.
|
DB Rimegepant
n=196 Participants
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.
|
DB Placebo
n=195 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Mild, Moderate and Severe AEs OLE Phase
Mild
|
65 Participants
|
57 Participants
|
65 Participants
|
|
Number of Participants With Mild, Moderate and Severe AEs OLE Phase
Moderate
|
30 Participants
|
22 Participants
|
25 Participants
|
|
Number of Participants With Mild, Moderate and Severe AEs OLE Phase
Severe
|
2 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: DBT: From Week 1 to Week 20Population: Double-blind treatment safety population included participants in the enrolled analysis set who took \>= 1 dose of double-blind study drug (rimegepant or placebo).
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.
Outcome measures
| Measure |
DB Rimegepant/ Placebo
n=232 Participants
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.
|
DB Rimegepant
n=229 Participants
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.
|
DB Placebo
n=231 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) in DBT Phase
|
3 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: OLE: From Week 12 to Week 32Population: Open-label rimegepant safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
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.
Outcome measures
| Measure |
DB Rimegepant/ Placebo
n=182 Participants
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.
|
DB Rimegepant
n=196 Participants
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.
|
DB Placebo
n=195 Participants
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.
|
|---|---|---|---|
|
Number of Participants With SAEs in OLE Phase
|
2 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: DBT: From Week 1 to Week 12Population: Double-blind treatment safety population included participants in the enrolled analysis set who took \>= 1 dose of double-blind study drug (rimegepant or placebo).
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.
Outcome measures
| Measure |
DB Rimegepant/ Placebo
n=232 Participants
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.
|
DB Rimegepant
n=229 Participants
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.
|
DB Placebo
n=231 Participants
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.
|
|---|---|---|---|
|
Number of Participants With AEs Leading to Study Drug Discontinuation in DBT Phase
|
6 Participants
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: OLE: From Week 12 to Week 24Population: Open-label rimegepant safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
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.
Outcome measures
| Measure |
DB Rimegepant/ Placebo
n=182 Participants
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.
|
DB Rimegepant
n=196 Participants
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.
|
DB Placebo
n=195 Participants
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.
|
|---|---|---|---|
|
Number of Participants With AEs Leading to Study Drug Discontinuation in OLE Phase
|
4 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: DBT: From Week 1 to Week 20Population: Double-blind treatment safety population included participants in the enrolled analysis set who took \>= 1 dose of double-blind study drug (rimegepant or placebo). All participants under 'Overall Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.
The laboratory parameters were graded according to the National Cancer Institute (NCI) common terminology criteria for adverse events (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 version v5.0 was used. Severity were graded as Grade 1=mild AE, Grade 2=moderate, Grade 3=severe, Grade 4=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 the treatment arms are reported.
Outcome measures
| Measure |
DB Rimegepant/ Placebo
n=232 Participants
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.
|
DB Rimegepant
n=229 Participants
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.
|
DB Placebo
n=231 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in DBT Phase
Lymphocytes, low
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in DBT Phase
Alanine Aminotransferase
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in DBT Phase
Aspartate Aminotransferase
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in DBT Phase
Creatine Kinase
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in DBT Phase
Glucose, low
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in DBT Phase
LDL Cholesterol
|
6 Participants
|
4 Participants
|
9 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in DBT Phase
LDL Cholesterol, fasting
|
4 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in DBT Phase
LDL Cholesterol, not fasting
|
2 Participants
|
1 Participants
|
6 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in DBT Phase
Sodium, high
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in DBT Phase
Triglycerides
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in DBT Phase
Triglycerides, fasting
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in DBT Phase
Urinalysis Glucose
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: OLE: From Week 12 to Week 32Population: Open-label rimegepant safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant. All participants under 'Overall Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.
The 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 version v5.0 was used. Severity was graded as Grade 1=mild AE, Grade 2=moderate, Grade 3=severe, Grade 4=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 the treatment arms are reported.
Outcome measures
| Measure |
DB Rimegepant/ Placebo
n=182 Participants
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.
|
DB Rimegepant
n=196 Participants
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.
|
DB Placebo
n=195 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in OLE Phase
Alanine Aminotransferase
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in OLE Phase
Aspartate Aminotransferase
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in OLE Phase
Creatine Kinase
|
3 Participants
|
0 Participants
|
5 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in OLE Phase
LDL Cholesterol
|
7 Participants
|
8 Participants
|
4 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in OLE Phase
LDL Cholesterol, fasting
|
4 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in OLE Phase
LDL Cholesterol, not fasting
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in OLE Phase
Potassium, low
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in OLE Phase
Potassium, high
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in OLE Phase
Triglycerides
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in OLE Phase
Triglycerides, not fasting
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in OLE Phase
Urinalysis Glucose
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: DBT: From Week 1 to Week 20Population: 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 outcome measure.
Number of participants with AST or ALT \>3\*ULN concurrent with TBL \>2\*ULN in DBT phase were reported in this outcome measure.
Outcome measures
| Measure |
DB Rimegepant/ Placebo
n=225 Participants
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.
|
DB Rimegepant
n=224 Participants
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.
|
DB Placebo
n=225 Participants
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.
|
|---|---|---|---|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: OLE: From Week 12 to Week 32Population: 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 outcome measure.
Number of participants with AST or ALT \>3\*ULN concurrent with TBL \>2\*ULN in DBT phase were reported in this outcome measure.
Outcome measures
| Measure |
DB Rimegepant/ Placebo
n=180 Participants
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.
|
DB Rimegepant
n=193 Participants
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.
|
DB Placebo
n=194 Participants
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.
|
|---|---|---|---|
|
Number of Participants With AST or ALT Elevations > 3* ULN Concurrent With TBL >2*ULN in OLE Phase
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: DBT: From Week 1 to Week 20Population: Double-blind treatment safety population included participants in the enrolled analysis set who took \>= 1 dose of double-blind study drug (rimegepant or placebo).
\\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 outcome measure.
Outcome measures
| Measure |
DB Rimegepant/ Placebo
n=232 Participants
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.
|
DB Rimegepant
n=229 Participants
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.
|
DB Placebo
n=231 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Hepatic-Related AEs in the DBT Phase
|
7 Participants
|
8 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: OLE: From Week 12 to Week 32Population: Open-label rimegepant safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
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 outcome measure.
Outcome measures
| Measure |
DB Rimegepant/ Placebo
n=182 Participants
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.
|
DB Rimegepant
n=196 Participants
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.
|
DB Placebo
n=195 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Hepatic-Related AEs in the OLE Phase
|
11 Participants
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: DBT: From Week 1 to Week 12Population: Double-blind treatment safety population included participants in the enrolled analysis set who took \>= 1 dose of double-blind study drug (rimegepant or placebo).
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 outcome measure.
Outcome measures
| Measure |
DB Rimegepant/ Placebo
n=232 Participants
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.
|
DB Rimegepant
n=229 Participants
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.
|
DB Placebo
n=231 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Hepatic-Related AEs Leading to Study Drug Discontinuation in the DBT Phase
|
4 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: OLE: From Week 12 to Week 24Population: Open-label rimegepant safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
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 outcome measure.
Outcome measures
| Measure |
DB Rimegepant/ Placebo
n=182 Participants
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.
|
DB Rimegepant
n=196 Participants
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.
|
DB Placebo
n=195 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Hepatic-Related AEs Leading to Study Drug Discontinuation in the OLE Phase
|
1 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
DB Rimegepant/ Placebo
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
DB Rimegepant
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
DB Placebo
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
DB RMG EOD/DB PBO EOD/ OL RMG QD
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
DB RMG QD/ OL RMG QD
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
DB PBO QD/ OL RMG QD
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DB Rimegepant/ Placebo
n=232 participants at risk
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.
|
DB Rimegepant
n=229 participants at risk
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.
|
DB Placebo
n=231 participants at risk
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.
|
DB RMG EOD/DB PBO EOD/ OL RMG QD
n=182 participants at risk
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.
|
DB RMG QD/ OL RMG QD
n=196 participants at risk
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.
|
DB PBO QD/ OL RMG QD
n=195 participants at risk
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.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Crohn's disease
|
0.43%
1/232 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/229 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/231 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/182 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/196 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/195 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/232 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/229 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/231 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/182 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/196 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.51%
1/195 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
|
Infections and infestations
Infected cyst
|
0.00%
0/232 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.44%
1/229 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/231 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/182 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/196 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/195 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/232 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/229 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.43%
1/231 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/182 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/196 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/195 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/232 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.44%
1/229 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/231 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/182 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/196 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/195 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/232 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/229 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/231 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/182 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/196 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.51%
1/195 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/232 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/229 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/231 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/182 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.51%
1/196 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/195 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/232 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/229 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/231 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.55%
1/182 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/196 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/195 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/232 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/229 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/231 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/182 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.51%
1/196 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/195 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.43%
1/232 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/229 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/231 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/182 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/196 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/195 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
|
Nervous system disorders
Status migrainosus
|
0.43%
1/232 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/229 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/231 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.55%
1/182 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/196 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/195 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
Other adverse events
| Measure |
DB Rimegepant/ Placebo
n=232 participants at risk
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.
|
DB Rimegepant
n=229 participants at risk
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.
|
DB Placebo
n=231 participants at risk
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.
|
DB RMG EOD/DB PBO EOD/ OL RMG QD
n=182 participants at risk
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.
|
DB RMG QD/ OL RMG QD
n=196 participants at risk
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.
|
DB PBO QD/ OL RMG QD
n=195 participants at risk
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.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
5.6%
13/232 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
5.7%
13/229 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
5.6%
13/231 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
7.1%
13/182 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
2.6%
5/196 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
3.6%
7/195 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
|
Infections and infestations
COVID-19
|
0.00%
0/232 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/229 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
0.00%
0/231 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
2.2%
4/182 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
7.1%
14/196 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
3.1%
6/195 • 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)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE.DB treatment safety population=participants in the enrolled analysis set who took\>=1 dose of DB study drug (rimegepant or placebo) used for DBT phase arms. OL RMG safety population included participants in the enrolled analysis set who took \>= 1 dose of open-label rimegepant.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER