Trial Outcomes & Findings for Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention (NCT NCT05207865)
NCT ID: NCT05207865
Last Updated: 2025-09-03
Results Overview
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and did not necessarily have causal relationship with treatment. On-treatment AEs were those AEs which occurred after the study treatment start date until 7 days after last dose of study treatment. AEs were classified according to intensity as: mild: transient and required minimal treatment or therapeutic intervention, event did not interfere with usual activities of daily living; moderate: alleviated with additional specific therapeutic intervention, event interfered with activities of daily living, causing discomfort; severe: interrupted activities of daily living, affected clinical status, or required intensive treatment. AEs occurring in \>=5% participants are reported in this OM.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
441 participants
Primary outcome timeframe
From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)
Results posted on
2025-09-03
Participant Flow
Out of the 441 enrolled participants, only 250 received study treatment; 184 participants failed screening, 6 participants were lost to follow-up and 1 participant withdrew consent.
Participant milestones
| Measure |
Rimegepant
Participants received a single dose of Rimegepant 75 milligrams (mg) orally disintegrating tablet (ODT) daily for 24 weeks during the open-label treatment phase.
|
|---|---|
|
Open-Label Treatment Phase
STARTED
|
250
|
|
Open-Label Treatment Phase
COMPLETED
|
187
|
|
Open-Label Treatment Phase
NOT COMPLETED
|
63
|
|
Follow-up Phase
STARTED
|
235
|
|
Follow-up Phase
COMPLETED
|
220
|
|
Follow-up Phase
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Rimegepant
Participants received a single dose of Rimegepant 75 milligrams (mg) orally disintegrating tablet (ODT) daily for 24 weeks during the open-label treatment phase.
|
|---|---|
|
Open-Label Treatment Phase
Adverse Event
|
7
|
|
Open-Label Treatment Phase
Lost to Follow-up
|
8
|
|
Open-Label Treatment Phase
Non-compliance
|
3
|
|
Open-Label Treatment Phase
Other
|
17
|
|
Open-Label Treatment Phase
Physician Decision
|
2
|
|
Open-Label Treatment Phase
Pregnancy
|
1
|
|
Open-Label Treatment Phase
Protocol Violation
|
1
|
|
Open-Label Treatment Phase
Protocol-specified withdrawal criterion met
|
14
|
|
Open-Label Treatment Phase
Withdrawal by Subject
|
10
|
|
Follow-up Phase
Lost to Follow-up
|
1
|
|
Follow-up Phase
Non-compliance
|
1
|
|
Follow-up Phase
Not reported
|
2
|
|
Follow-up Phase
Not collected
|
11
|
Baseline Characteristics
Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention
Baseline characteristics by cohort
| Measure |
Rimegepant
n=250 Participants
Participants received a single dose of Rimegepant 75 mg ODT daily for 24 weeks during the open-label treatment phase.
|
|---|---|
|
Age, Continuous
|
42.6 Years
STANDARD_DEVIATION 14.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
206 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
215 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
216 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)Population: Safety analysis set included participants in the enrolled analysis set who took greater than or equal to (\>=) 1 dose of study drug (rimegepant), i.e., nonmissing study drug start date.
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and did not necessarily have causal relationship with treatment. On-treatment AEs were those AEs which occurred after the study treatment start date until 7 days after last dose of study treatment. AEs were classified according to intensity as: mild: transient and required minimal treatment or therapeutic intervention, event did not interfere with usual activities of daily living; moderate: alleviated with additional specific therapeutic intervention, event interfered with activities of daily living, causing discomfort; severe: interrupted activities of daily living, affected clinical status, or required intensive treatment. AEs occurring in \>=5% participants are reported in this OM.
Outcome measures
| Measure |
Rimegepant
n=250 Participants
Participants received a single dose of Rimegepant 75 mg ODT daily for 24 weeks during the open-label treatment phase.
|
|---|---|
|
Number of Participants With On-Treatment Adverse Events (AEs) (Frequency >=5%) According to Intensity
Mild
|
33 Participants
|
|
Number of Participants With On-Treatment Adverse Events (AEs) (Frequency >=5%) According to Intensity
Moderate
|
17 Participants
|
|
Number of Participants With On-Treatment Adverse Events (AEs) (Frequency >=5%) According to Intensity
Moderate or severe
|
17 Participants
|
PRIMARY outcome
Timeframe: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)Population: Safety analysis set included participants in the enrolled analysis set who took \>= 1 dose of study drug (rimegepant), i.e., nonmissing study drug start date.
An SAE was any event that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; was persistent or caused significant disability/incapacity or congenital anomaly/birth defect in the offspring of a participant who received Rimegepant, or other important medical events. On-treatment AEs were those AEs which occurred after the study treatment start date until 7 days after last dose of study treatment.
Outcome measures
| Measure |
Rimegepant
n=250 Participants
Participants received a single dose of Rimegepant 75 mg ODT daily for 24 weeks during the open-label treatment phase.
|
|---|---|
|
Number of Participants With On-Treatment Serious Adverse Events (SAEs)
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)Population: Safety analysis set included participants in the enrolled analysis set who took \>= 1 dose of study drug (rimegepant), i.e., nonmissing study drug start date.
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and did not necessarily have causal relationship with treatment. Number of participants with AEs leading to study drug discontinuations are reported in this outcome measure.
Outcome measures
| Measure |
Rimegepant
n=250 Participants
Participants received a single dose of Rimegepant 75 mg ODT daily for 24 weeks during the open-label treatment phase.
|
|---|---|
|
Number of Participants With AEs Leading to Study Drug Discontinuation
|
7 Participants
|
PRIMARY outcome
Timeframe: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)Population: Safety analysis set included participants in the enrolled analysis set who took \>= 1 dose of study drug (rimegepant), i.e., nonmissing study drug start date. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row and "Number Analyzed" signifies participants evaluable for specified rows.
The following laboratory parameters were assessed: eosinophils, hemoglobin low and high, leukocytes low, lymphocytes low and high, neutrophils, platelets, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium low and high, cholesterol, creatine kinase, creatinine, glomerular filtration rate estimated, glucose low and high, lactate dehydrogenase, low-density lipoprotein (LDL) cholesterol, LDL cholesterol fasting and not fasting, potassium low and high, sodium low and high, triglycerides, triglycerides fasting and not fasting, uric acid, urine glucose and urine protein. Laboratory abnormalities were graded according to NCI CTCAE v5.0; where grade 3=severe and grade 4=life-threatening except for glucose, LDL cholesterol, and urinalysis where DAIDS v2.1 was used. (grade 3= severe and grade 4= life-threatening).
Outcome measures
| Measure |
Rimegepant
n=250 Participants
Participants received a single dose of Rimegepant 75 mg ODT daily for 24 weeks during the open-label treatment phase.
|
|---|---|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Eosinophils
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Hemoglobin, low
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Hemoglobin, high
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Leukocytes, low
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Lymphocytes, low
|
1 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Lymphocytes, high
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Neutrophils
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Platelets
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Alanine Aminotransferase
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Albumin
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Alkaline Phosphatase
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Aspartate Aminotransferase
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Bicarbonate
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Bilirubin
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Calcium, low
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Calcium, high
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Cholesterol
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Creatine Kinase
|
9 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Creatinine
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Glomerular Filtration Rate, Estimated
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Glucose, low
|
1 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Glucose, high
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Lactate Dehydrogenase
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
LDL Cholesterol
|
22 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
LDL Cholesterol, fasting
|
14 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
LDL Cholesterol, not fasting
|
9 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Potassium, low
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Potassium, high
|
3 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Sodium, low
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Sodium, high
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Triglycerides
|
2 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Triglycerides, fasting
|
2 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Triglycerides, not fasting
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Uric Acid
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Urine Glucose
|
1 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Urine Protein
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)Population: Safety analysis set included participants in the enrolled analysis set who took \>= 1 dose of study drug (rimegepant), i.e., nonmissing study drug start date. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row and "Number Analyzed" signifies participants evaluable for specified rows.
The following laboratory parameters were assessed: eosinophils, hemoglobin, leukocytes low, lymphocytes low and high, neutrophils, platelets, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urine nitrogen, calcium low and high, cholesterol, creatine, glucose low and high, potassium low and high, protein, sodium low and high, urine glucose and urine protein. Laboratory abnormality events were graded according to FDA toxicity grading scale (grade 3= severe and grade 4= life-threatening).
Outcome measures
| Measure |
Rimegepant
n=250 Participants
Participants received a single dose of Rimegepant 75 mg ODT daily for 24 weeks during the open-label treatment phase.
|
|---|---|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
Eosinophils
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
Hemoglobin
|
4 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
Leukocytes, low
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
Leukocytes, high
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
Lymphocytes
|
1 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
Neutrophils
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
Platelets
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
Alanine Aminotransferase
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
Albumin
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
Alkaline Phosphatase
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
Aspartate Aminotransferase
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
Bilirubin
|
1 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
Blood Urine Nitrogen
|
1 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
Calcium, low
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
Calcium, high
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
Cholesterol
|
54 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
Creatinine
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
Glucose, low
|
4 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
Glucose, high
|
19 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
Potassium, low
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
Potassium, high
|
10 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
Protein
|
1 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
Sodium, low
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
Sodium, high
|
6 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
Urine Glucose
|
1 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
Urine Protein
|
0 Participants
|
Adverse Events
Rimegepant (On-treatment Period)
Serious events: 0 serious events
Other events: 48 other events
Deaths: 0 deaths
Rimegepant (Follow-up Period)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rimegepant (On-treatment Period)
n=250 participants at risk
Participants received a single dose of Rimegepant 75 mg ODT daily for 24 weeks during the open-label treatment phase.
|
Rimegepant (Follow-up Period)
n=235 participants at risk
Participants were followed up from 2 weeks after last dose of study treatment up to 8 weeks after last dose of study treatment.
|
|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/250 • For On-treatment period: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks); For Follow-up period- from 2 weeks after last dose of study treatment up to 8 weeks after last dose of study treatment
Safety analysis set included participants in the enrolled analysis set who took \>= 1 dose of study drug (rimegepant), i.e., nonmissing study drug start date.
|
0.43%
1/235 • For On-treatment period: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks); For Follow-up period- from 2 weeks after last dose of study treatment up to 8 weeks after last dose of study treatment
Safety analysis set included participants in the enrolled analysis set who took \>= 1 dose of study drug (rimegepant), i.e., nonmissing study drug start date.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/250 • For On-treatment period: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks); For Follow-up period- from 2 weeks after last dose of study treatment up to 8 weeks after last dose of study treatment
Safety analysis set included participants in the enrolled analysis set who took \>= 1 dose of study drug (rimegepant), i.e., nonmissing study drug start date.
|
0.43%
1/235 • For On-treatment period: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks); For Follow-up period- from 2 weeks after last dose of study treatment up to 8 weeks after last dose of study treatment
Safety analysis set included participants in the enrolled analysis set who took \>= 1 dose of study drug (rimegepant), i.e., nonmissing study drug start date.
|
Other adverse events
| Measure |
Rimegepant (On-treatment Period)
n=250 participants at risk
Participants received a single dose of Rimegepant 75 mg ODT daily for 24 weeks during the open-label treatment phase.
|
Rimegepant (Follow-up Period)
n=235 participants at risk
Participants were followed up from 2 weeks after last dose of study treatment up to 8 weeks after last dose of study treatment.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
9.2%
23/250 • For On-treatment period: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks); For Follow-up period- from 2 weeks after last dose of study treatment up to 8 weeks after last dose of study treatment
Safety analysis set included participants in the enrolled analysis set who took \>= 1 dose of study drug (rimegepant), i.e., nonmissing study drug start date.
|
0.43%
1/235 • For On-treatment period: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks); For Follow-up period- from 2 weeks after last dose of study treatment up to 8 weeks after last dose of study treatment
Safety analysis set included participants in the enrolled analysis set who took \>= 1 dose of study drug (rimegepant), i.e., nonmissing study drug start date.
|
|
Infections and infestations
COVID-19
|
6.4%
16/250 • For On-treatment period: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks); For Follow-up period- from 2 weeks after last dose of study treatment up to 8 weeks after last dose of study treatment
Safety analysis set included participants in the enrolled analysis set who took \>= 1 dose of study drug (rimegepant), i.e., nonmissing study drug start date.
|
0.00%
0/235 • For On-treatment period: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks); For Follow-up period- from 2 weeks after last dose of study treatment up to 8 weeks after last dose of study treatment
Safety analysis set included participants in the enrolled analysis set who took \>= 1 dose of study drug (rimegepant), i.e., nonmissing study drug start date.
|
|
Gastrointestinal disorders
Nausea
|
6.0%
15/250 • For On-treatment period: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks); For Follow-up period- from 2 weeks after last dose of study treatment up to 8 weeks after last dose of study treatment
Safety analysis set included participants in the enrolled analysis set who took \>= 1 dose of study drug (rimegepant), i.e., nonmissing study drug start date.
|
0.43%
1/235 • For On-treatment period: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks); For Follow-up period- from 2 weeks after last dose of study treatment up to 8 weeks after last dose of study treatment
Safety analysis set included participants in the enrolled analysis set who took \>= 1 dose of study drug (rimegepant), i.e., nonmissing study drug start date.
|
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 publications 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