Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention (NCT NCT04804033)
NCT ID: NCT04804033
Last Updated: 2025-03-27
Results Overview
A migraine day was defined as any calendar day in which participant experienced a qualified migraine headache (onset, continuation or recurrence of migraine headache). A qualified migraine headache was defined as migraine with or without aura, lasting for greater than or equal to (\>=) 30 minutes, and met at least one of the following criteria (A and/or B): A. \>=2 of the following pain features: a. Unilateral location, b. Pulsating quality (throbbing), c. Moderate or severe pain intensity, d. Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs) B. \>= 1 of following associated symptoms: a. Nausea and/or vomiting b. Photophobia and phonophobia. The number of migraine days per month were prorated to 28 days and derived as follows: 28\*(total number of migraine days through Month 3\[Weeks 1 to 12\] in on-DBT efficacy analysis period)/ (total number of eDiary efficacy data days through Month 3\[Weeks 1 to 12\] in the on-DBT efficacy analysis period).
TERMINATED
PHASE2/PHASE3
1753 participants
Observation Phase: 28 days prior to randomization and baseline; Entire DBT Phase: 12 weeks (Week 1 through 12)
2025-03-27
Participant Flow
The study enrolled 1753 participants, out of which 1219 were not randomized. Only 534 participants were randomized in a 12-week double-blind treatment (DBT) phase. A total of 298 eligible participants then entered in a 52-week open-label extension (OLE) phase. Participants had a follow-up of 8 weeks after discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase.
Participant milestones
| Measure |
Zavegepant 100 mg (OLE/DBT)
Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \*4 capsules) daily for 12 weeks in DBT phase. Eligible participants continued to receive Zavegepant in similar manner for another 52 weeks in OLE phase.
|
Zavegepant 200 mg (OLE/DBT)
Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 12 weeks in DBT phase. Eligible participants continued to receive Zavegepant in similar manner for another 52 weeks in OLE phase.
|
Placebo (DBT)/ Zavegepant 100 mg (OLE)
Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase. Eligible participants received Zavegepant 100 mg orally as soft gelatin capsules (25 mg \*4 capsules) daily for 52 weeks in OLE phase.
|
Placebo (DBT)/ Zavegepant 200 mg (OLE)
Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase. Eligible participants received Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 52 weeks in OLE phase.
|
|---|---|---|---|---|
|
Period 1: DBT Phase
STARTED
|
178
|
180
|
88
|
88
|
|
Period 1: DBT Phase
Treated
|
173
|
175
|
86
|
88
|
|
Period 1: DBT Phase
COMPLETED
|
144
|
134
|
69
|
64
|
|
Period 1: DBT Phase
NOT COMPLETED
|
34
|
46
|
19
|
24
|
|
Period 2: OLE Phase
STARTED
|
105
|
94
|
50
|
49
|
|
Period 2: OLE Phase
Treated
|
105
|
94
|
50
|
49
|
|
Period 2: OLE Phase
COMPLETED
|
34
|
34
|
22
|
17
|
|
Period 2: OLE Phase
NOT COMPLETED
|
71
|
60
|
28
|
32
|
|
Period 3: Follow-up Phase
STARTED
|
154
|
162
|
47
|
48
|
|
Period 3: Follow-up Phase
COMPLETED
|
124
|
131
|
41
|
38
|
|
Period 3: Follow-up Phase
NOT COMPLETED
|
30
|
31
|
6
|
10
|
Reasons for withdrawal
| Measure |
Zavegepant 100 mg (OLE/DBT)
Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \*4 capsules) daily for 12 weeks in DBT phase. Eligible participants continued to receive Zavegepant in similar manner for another 52 weeks in OLE phase.
|
Zavegepant 200 mg (OLE/DBT)
Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 12 weeks in DBT phase. Eligible participants continued to receive Zavegepant in similar manner for another 52 weeks in OLE phase.
|
Placebo (DBT)/ Zavegepant 100 mg (OLE)
Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase. Eligible participants received Zavegepant 100 mg orally as soft gelatin capsules (25 mg \*4 capsules) daily for 52 weeks in OLE phase.
|
Placebo (DBT)/ Zavegepant 200 mg (OLE)
Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase. Eligible participants received Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 52 weeks in OLE phase.
|
|---|---|---|---|---|
|
Period 1: DBT Phase
Adverse Event
|
1
|
5
|
3
|
4
|
|
Period 1: DBT Phase
Death
|
1
|
0
|
0
|
0
|
|
Period 1: DBT Phase
Lost to Follow-up
|
3
|
7
|
1
|
3
|
|
Period 1: DBT Phase
Non-compliance
|
1
|
0
|
1
|
2
|
|
Period 1: DBT Phase
Other
|
0
|
1
|
0
|
0
|
|
Period 1: DBT Phase
Pregnancy
|
2
|
0
|
0
|
0
|
|
Period 1: DBT Phase
Study terminated by sponsor
|
15
|
16
|
5
|
9
|
|
Period 1: DBT Phase
Withdrawal by Subject
|
6
|
12
|
7
|
6
|
|
Period 1: DBT Phase
Randomized but not treated
|
5
|
5
|
2
|
0
|
|
Period 2: OLE Phase
Adverse Event
|
3
|
4
|
2
|
0
|
|
Period 2: OLE Phase
Lost to Follow-up
|
8
|
4
|
3
|
4
|
|
Period 2: OLE Phase
Non-compliance
|
2
|
2
|
0
|
1
|
|
Period 2: OLE Phase
Other
|
0
|
2
|
0
|
0
|
|
Period 2: OLE Phase
Physician Decision
|
1
|
1
|
0
|
0
|
|
Period 2: OLE Phase
Pregnancy
|
0
|
0
|
2
|
0
|
|
Period 2: OLE Phase
Study terminated by sponsor
|
41
|
37
|
17
|
19
|
|
Period 2: OLE Phase
Withdrawal by Subject
|
16
|
8
|
3
|
7
|
|
Period 2: OLE Phase
Not reported
|
0
|
2
|
0
|
0
|
|
Period 2: OLE Phase
Failure to meet continuation criteria
|
0
|
0
|
1
|
1
|
|
Period 3: Follow-up Phase
Lost to Follow-up
|
5
|
9
|
0
|
1
|
|
Period 3: Follow-up Phase
Other
|
0
|
1
|
2
|
1
|
|
Period 3: Follow-up Phase
Withdrawal by Subject
|
7
|
6
|
3
|
4
|
|
Period 3: Follow-up Phase
Not reported
|
18
|
15
|
1
|
4
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention
Baseline characteristics by cohort
| Measure |
Zavegepant 100 mg (DBT)
n=173 Participants
Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \*4 capsules) daily for 12 weeks in DBT phase.
|
Zavegepant 200 mg (DBT)
n=175 Participants
Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 100 mg
n=86 Participants
Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 200 mg
n=88 Participants
Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.
|
Total
n=522 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Continuous
|
41.7 Years
STANDARD_DEVIATION 12.85 • n=5 Participants
|
43.2 Years
STANDARD_DEVIATION 13.30 • n=7 Participants
|
41.7 Years
STANDARD_DEVIATION 13.15 • n=5 Participants
|
41.5 Years
STANDARD_DEVIATION 13.14 • n=4 Participants
|
42.2 Years
STANDARD_DEVIATION 13.09 • n=21 Participants
|
|
Sex: Female, Male
Female
|
127 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
413 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
109 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
48 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
148 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
125 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
374 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
103 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
130 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
391 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Observation Phase: 28 days prior to randomization and baseline; Entire DBT Phase: 12 weeks (Week 1 through 12)Population: Migraine analysis set included participants in the DBT efficacy analysis set with \>= 14 days of e-diary efficacy data in both the observation phase and \>= 1 month (4-week interval) in the DBT phase. DBT efficacy analysis set: participants who were enrolled and randomized only once and took \>=1 dose of DB study drug (zavegepant or placebo). Results were summarized by treatment group and the 2 matching placebo groups were pooled as pre-specified in protocol/ statistical analysis plan (SAP).
A migraine day was defined as any calendar day in which participant experienced a qualified migraine headache (onset, continuation or recurrence of migraine headache). A qualified migraine headache was defined as migraine with or without aura, lasting for greater than or equal to (\>=) 30 minutes, and met at least one of the following criteria (A and/or B): A. \>=2 of the following pain features: a. Unilateral location, b. Pulsating quality (throbbing), c. Moderate or severe pain intensity, d. Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs) B. \>= 1 of following associated symptoms: a. Nausea and/or vomiting b. Photophobia and phonophobia. The number of migraine days per month were prorated to 28 days and derived as follows: 28\*(total number of migraine days through Month 3\[Weeks 1 to 12\] in on-DBT efficacy analysis period)/ (total number of eDiary efficacy data days through Month 3\[Weeks 1 to 12\] in the on-DBT efficacy analysis period).
Outcome measures
| Measure |
Zavegepant 100 mg (DBT)
n=164 Participants
Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \*4 capsules) daily for 12 weeks in DBT phase.
|
Zavegepant 200 mg (DBT)
n=163 Participants
Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
n=165 Participants
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 100 mg
Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 200 mg
Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
|---|---|---|---|---|---|---|
|
Mean Change From Observation Phase (OP) in the Number of Migraine Days Per Month Over Entire DBT Phase (Weeks 1 to 12)
|
-7.0 Migraine Days per Month
Interval -8.1 to -5.92
|
-6.3 Migraine Days per Month
Interval -7.45 to -5.1
|
-5.6 Migraine Days per Month
Interval -6.8 to -4.37
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Entire DBT Phase: 12 weeks (Week 1 through 12)Population: Migraine analysis set included participants in the DBT efficacy analysis set with \>= 14 days of e-diary efficacy data in both the observation phase and \>= 1 month (4-week interval) in the DBT phase. DBT efficacy analysis set: participants who were enrolled and randomized only once and took \>=1 dose of DB study drug (zavegepant or placebo). Results were summarized by treatment group and the 2 matching placebo groups were pooled as pre-specified in protocol/ SAP.
A migraine day was defined as any calendar day in which participant experienced a qualified migraine headache (onset, continuation or recurrence of the migraine headache). A qualified migraine headache was defined as migraine with or without aura, lasting for greater than or equal to (\>=) 30 minutes, and met at least one of following criteria (A and/or B): A. \>=2 of following pain features: a. Unilateral location, b. Pulsating quality (throbbing), c. Moderate or severe pain intensity, d. Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs) B. \>= 1 of the following associated symptoms: a. Nausea and/or vomiting b. Photophobia and phonophobia. The number of migraine days per month were prorated to 28 days and derived as follows: 28\*(total number of migraine days through Month 3\[Weeks 1 to 12\] in the on-DBT efficacy analysis period)/ (total number of eDiary efficacy data days through Month 3\[Weeks 1 to 12\] in on-DBT efficacy analysis period).
Outcome measures
| Measure |
Zavegepant 100 mg (DBT)
n=164 Participants
Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \*4 capsules) daily for 12 weeks in DBT phase.
|
Zavegepant 200 mg (DBT)
n=163 Participants
Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
n=165 Participants
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 100 mg
Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 200 mg
Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With >= 50 % Reduction in Number of Moderate to Severe Migraine Days Per Month Over Entire DBT Phase (Weeks 1 to 12)
|
56.1 Percentage of participants
Interval 47.7 to 65.1
|
46.6 Percentage of participants
Interval 37.8 to 55.4
|
40.0 Percentage of participants
Interval 31.4 to 48.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Observation Phase: 28 days prior to randomization and baseline; DBT Phase: last 4 weeks (Week 9 through 12)Population: Migraine analysis set analyzed. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Results were summarized by treatment group and the 2 matching placebo groups were pooled as pre-specified in protocol/ SAP.
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 greater than or equal to (\>=) 30 minutes, and met at least one of the following criteria (A and/or B): A.\>=2 of the following pain features: a. Unilateral location, b. Pulsating quality (throbbing), c. Moderate or severe pain intensity, d. Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs) B. \>= 1 of the following associated symptoms: a. Nausea and/or vomiting b. Photophobia and phonophobia. The number of migraine days per month were prorated to 28 days and derived for month (i.e., 4-week interval) in on-DBT efficacy analysis period as follows: 28\* (total number of migraine days in the month\[Week 9 to 12\])/(total number of eDiary efficacy data days in the month\[Week 9 to 12\]).
Outcome measures
| Measure |
Zavegepant 100 mg (DBT)
n=137 Participants
Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \*4 capsules) daily for 12 weeks in DBT phase.
|
Zavegepant 200 mg (DBT)
n=123 Participants
Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
n=126 Participants
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 100 mg
Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 200 mg
Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
|---|---|---|---|---|---|---|
|
Mean Change From Observation Phase in the Number of Migraine Days Per Month in the Last 4 Weeks (Weeks 9 to 12) of DBT Phase
|
-7.8 Migraine Days per Month
Interval -9.11 to -6.59
|
-7.2 Migraine Days per Month
Interval -8.56 to -5.83
|
-6.8 Migraine Days per Month
Interval -8.22 to -5.38
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Observation Phase: 28 days prior to randomization and baseline; DBT Phase: first 4 weeks (Week 1 through 4)Population: Migraine analysis set analyzed. Results were summarized by treatment group and the 2 matching placebo groups were pooled as pre-specified in protocol/ SAP. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
A migraine day was defined as any calendar day in which 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 greater than or equal to (\>=) 30 minutes, and met at least one of the following criteria (A and/or B): A. \>=2 of the following pain features: a. Unilateral location, b. Pulsating quality (throbbing), c. Moderate or severe pain intensity, d. Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs) B. \>= 1 of the following associated symptoms: a. Nausea and/or vomiting b. Photophobia and phonophobia. The number of migraine days per month were prorated to 28 days and derived for month (i.e., 4-week interval) in the on-DBT efficacy analysis period as follows: 28\* (total number of migraine days in the month\[Week 1 to 4\])/ (total number of eDiary efficacy data days in the month\[Week 1 to 4\]).
Outcome measures
| Measure |
Zavegepant 100 mg (DBT)
n=162 Participants
Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \*4 capsules) daily for 12 weeks in DBT phase.
|
Zavegepant 200 mg (DBT)
n=161 Participants
Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
n=164 Participants
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 100 mg
Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 200 mg
Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
|---|---|---|---|---|---|---|
|
Mean Change From Observation Phase in the Number of Migraine Days Per Month in the First 4 Weeks (Weeks 1 to 4) of DBT Phase
|
-5.7 Migraine Days per Month
Interval -6.89 to -4.51
|
-5.1 Migraine Days per Month
Interval -6.26 to -3.87
|
-3.9 Migraine Days per Month
Interval -5.1 to -2.72
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Entire DBT Phase: 12 weeks (Week 1 through 12)Population: Migraine analysis set included participants in the DBT efficacy analysis set with \>= 14 days of e-diary efficacy data in both the observation phase and \>= 1 month (4-week interval) in the DBT phase. DBT efficacy analysis set: participants who were enrolled and randomized only once and took \>=1 dose of DB study drug (zavegepant or placebo). Results were summarized by treatment group and the 2 matching placebo groups were pooled as pre-specified in protocol/ SAP.
Acute migraine (AM)-specific medication day was defined as any calendar day on which the participant took an acute migraine-specific medication during aura or to treat a headache. Acute migraine-specific medications were triptans and ergotamine. The number of acute migraine-specific medication days per month were prorated to 28 days and derived as follows: 28 \* (total number of acute migraine-specific medication days through Month 3 \[Week 1 to 12\] in the on-DBT efficacy analysis period)/ (total number of eDiary efficacy data days through Month 3 \[Week 1 to 12\] in the on-DBT efficacy analysis period).
Outcome measures
| Measure |
Zavegepant 100 mg (DBT)
n=164 Participants
Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \*4 capsules) daily for 12 weeks in DBT phase.
|
Zavegepant 200 mg (DBT)
n=163 Participants
Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
n=165 Participants
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 100 mg
Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 200 mg
Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
|---|---|---|---|---|---|---|
|
Mean Number of Acute Migraine -Specific Medication Days Per Month Over Entire DBT Phase (Weeks 1 to 12)
|
2.4 AM-specific Medication Days per Month
Interval 1.43 to 3.43
|
3.0 AM-specific Medication Days per Month
Interval 1.91 to 4.17
|
3.2 AM-specific Medication Days per Month
Interval 1.94 to 4.46
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: DBT Phase: Baseline (before dose on Day 1), Week 12Population: DBT efficacy analysis set included participants in the full analysis set who were randomized only once and took \>= 1 dose of DB study drug (zavegepant or placebo). Here, " Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Results were summarized by treatment group and the 2 matching placebo groups were pooled as pre-specified in protocol/ SAP.
MSQ v 2.1 is 14-item questionnaire that assessed impact of treatment on participant-reported quality of life across 3 domains: role function-restrictive, preventive, and emotional function. Restrictive role function domain consists of 7 items that describe how migraine limits one's daily social, work-related activities. Participants respond to items using a 6-point scale ranging from 1 (none of the time) to 6 (all of the time), which are assigned scores of 1 to 6, respectively. Response from each item of restrictive role function domain were added providing a possible raw score range of 7 (no impairment) to 42 (maximum impairment). Raw score range of restrictive role function domain was then transformed to a 0 (no impairment) to 100 (maximum impairment), higher scores = higher impairment.
Outcome measures
| Measure |
Zavegepant 100 mg (DBT)
n=143 Participants
Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \*4 capsules) daily for 12 weeks in DBT phase.
|
Zavegepant 200 mg (DBT)
n=125 Participants
Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
n=136 Participants
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 100 mg
Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 200 mg
Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in the Migraine-specific Quality of Life Questionnaire (MSQ) v 2.1 Restrictive Role Function Domain Score at Week 12
|
24.5 Scores on a scale
Interval 19.1 to 29.83
|
20.6 Scores on a scale
Interval 14.63 to 26.61
|
20.5 Scores on a scale
Interval 14.92 to 26.12
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: DBT Phase: Baseline (before dose on Day 1), Week 12Population: DBT efficacy analysis set included participants in the full analysis set who were randomized only once and took \>= 1 dose of DB study drug (zavegepant or placebo). Here, " Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Results were summarized by treatment group and the 2 matching placebo groups were pooled as pre-specified in protocol/ SAP.
MIDAS is a retrospective, participant-reported, 5-item questionnaire that measured headache related disability as lost days due to headache from paid work or school, household work and non-work activities over past 3-months. The total score is calculated as the sum of item scores to all 5 questions on a scale of 0 (no disability) to 90 (maximum disability) resulting into overall possible MIDAS total score (range from 0 (no disability) to 450 (maximum disability). Higher scores = more severe disability.
Outcome measures
| Measure |
Zavegepant 100 mg (DBT)
n=143 Participants
Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \*4 capsules) daily for 12 weeks in DBT phase.
|
Zavegepant 200 mg (DBT)
n=125 Participants
Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
n=135 Participants
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 100 mg
Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 200 mg
Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in the Migraine Disability Assessment (MIDAS) Total Score at Week 12
|
-26.8 Scores on a scale
Interval -35.81 to -17.79
|
-27.1 Scores on a scale
Interval -36.62 to -17.61
|
-17.9 Scores on a scale
Interval -31.36 to -4.34
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: DBT Phase: During 12 weeks of treatmentPopulation: DBT safety analysis set included the participants who were enrolled and took \>= 1 dose of DB study drug (zavegepant or placebo), i.e., non-missing study drug start date.
AEs: new untoward medical occurrence or worsening of a pre-existing medical condition in participant or clinical investigation participant administered investigational product that does not necessarily have a causal relationship with treatment. AEs included both SAEs and all non-SAEs. Severity: Moderate=Alleviated with additional specific therapeutic intervention, interfered with activities of daily living, causing discomfort, but possessed no significant or permanent risk of harm. Severe= Interrupted activities of daily living significantly affected clinical status or required intensive therapeutic intervention.
Outcome measures
| Measure |
Zavegepant 100 mg (DBT)
n=173 Participants
Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \*4 capsules) daily for 12 weeks in DBT phase.
|
Zavegepant 200 mg (DBT)
n=175 Participants
Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
n=348 Participants
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 100 mg
n=86 Participants
Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 200 mg
n=88 Participants
Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
n=174 Participants
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Moderate or Severe Adverse Events (AEs): DBT Phase
|
20 Participants
|
25 Participants
|
45 Participants
|
13 Participants
|
9 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: DBT Phase: During 12 weeks of treatmentPopulation: DBT safety analysis set included the participants who were enrolled and took \>= 1 dose of DB study drug (zavegepant or placebo), i.e., non-missing study drug start date.
AEs: new untoward medical occurrence or worsening of a pre-existing medical condition in participant or clinical investigation participant administered investigational product that does not necessarily have a causal relationship with treatment. SAE was defined as any event that met any of the following criteria: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention.
Outcome measures
| Measure |
Zavegepant 100 mg (DBT)
n=173 Participants
Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \*4 capsules) daily for 12 weeks in DBT phase.
|
Zavegepant 200 mg (DBT)
n=175 Participants
Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
n=348 Participants
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 100 mg
n=86 Participants
Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 200 mg
n=88 Participants
Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
n=174 Participants
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs): DBT Phase
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: DBT Phase: During 12 weeks of treatmentPopulation: DBT safety analysis set included the participants in the who were enrolled and who took \>=1 dose of DB study drug (zavegepant or placebo), i.e., non-missing study drug start date.
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 does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Zavegepant 100 mg (DBT)
n=173 Participants
Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \*4 capsules) daily for 12 weeks in DBT phase.
|
Zavegepant 200 mg (DBT)
n=175 Participants
Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
n=348 Participants
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 100 mg
n=86 Participants
Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 200 mg
n=88 Participants
Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
n=174 Participants
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
|---|---|---|---|---|---|---|
|
Number of Participants With AEs Leading to Study Drug Discontinuation: DBT Phase
|
2 Participants
|
5 Participants
|
7 Participants
|
3 Participants
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: DBT: During 12 weeks of treatmentPopulation: DBT safety analysis set included the participants in the who were enrolled and who took \>=1 dose of DB study drug (zavegepant or placebo), i.e., non-missing study drug start date. Participants reported under "Overall Number of Participants Analyzed" contributed data but may not be evaluable for every row and "Number Analyzed" signifies participants evaluable for the specified rows.
Laboratory tests included eosinophils, hemoglobin, leukocytes, lymphocytes, neutrophils, platelets; albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bicarbonate, bilirubin, calcium, cholesterol, potassium, sodium, triglycerides, uric acid, urinalysis, urine protein, creatine kinase (CK), creatinine, glomerular filtration rate (GFR), glucose, glucose fasting, lactate dehydrogenase, low density lipoprotein (LDL) Cholesterol, LDL Cholesterol. Number of participants with grade 3 to 4 laboratory test abnormalities were evaluated in this outcome measure. Only rows which included at least 1 participant in any reporting group with grade 3 to 4 abnormality were reported in this outcome measure. As per Common Terminology Criteria for Adverse Events (CTCAE version 5.0) Grade 3= severe and Grade 4= life-threatening or disabling.
Outcome measures
| Measure |
Zavegepant 100 mg (DBT)
n=173 Participants
Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \*4 capsules) daily for 12 weeks in DBT phase.
|
Zavegepant 200 mg (DBT)
n=175 Participants
Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
n=348 Participants
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 100 mg
n=86 Participants
Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 200 mg
n=88 Participants
Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
n=174 Participants
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: DBT Phase
Hemoglobin
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: DBT Phase
Creatine Kinase
|
5 Participants
|
7 Participants
|
12 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: DBT Phase
LDL Cholesterol
|
7 Participants
|
6 Participants
|
13 Participants
|
2 Participants
|
5 Participants
|
7 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: DBT Phase
LDL Cholesterol, fasting
|
4 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: DBT Phase
LDL Cholesterol, not fasting
|
0 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: DBT Phase
Potassium, high
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: DBT Phase
Triglycerides
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: DBT Phase
Urinalysis
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: OLE: During 52 weeks of treatmentPopulation: OL safety analysis set included the participants who took \>= 1 dose of OL zavegepant, i.e., nonmissing OL zavegepant start date.
AEs: new untoward medical occurrence or worsening of a pre-existing medical condition in participant or clinical investigation participant administered investigational product that does not necessarily have a causal relationship with treatment. AEs included both SAEs and all non-SAEs. Severity: Moderate=Alleviated with additional specific therapeutic intervention, interfered with activities of daily living, causing discomfort, but possessed no significant or permanent risk of harm. Severe= Interrupted activities of daily living significantly affected clinical status or required intensive therapeutic intervention.
Outcome measures
| Measure |
Zavegepant 100 mg (DBT)
n=155 Participants
Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \*4 capsules) daily for 12 weeks in DBT phase.
|
Zavegepant 200 mg (DBT)
n=143 Participants
Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 100 mg
Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 200 mg
Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Moderate or Severe AEs: OLE Phase
|
29 Participants
|
37 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: OLE: During 52 weeks of treatmentPopulation: OL safety analysis set included the participants who took \>= 1 dose of OL zavegepant, i.e., nonmissing OL zavegepant start date.
AEs: new untoward medical occurrence or worsening of a pre-existing medical condition in participant or clinical investigation participant administered investigational product that does not necessarily have a causal relationship with treatment. SAE was defined as any event that met any of the following criteria: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention.
Outcome measures
| Measure |
Zavegepant 100 mg (DBT)
n=155 Participants
Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \*4 capsules) daily for 12 weeks in DBT phase.
|
Zavegepant 200 mg (DBT)
n=143 Participants
Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 100 mg
Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 200 mg
Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
|---|---|---|---|---|---|---|
|
Number of Participants With SAEs: OLE Phase
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: OLE: During 52 weeks of treatmentPopulation: OL safety analysis set included the participants who took \>= 1 dose of OL zavegepant, i.e., nonmissing OL zavegepant start date.
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 does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Zavegepant 100 mg (DBT)
n=155 Participants
Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \*4 capsules) daily for 12 weeks in DBT phase.
|
Zavegepant 200 mg (DBT)
n=143 Participants
Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 100 mg
Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 200 mg
Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
|---|---|---|---|---|---|---|
|
Number of Participants With AEs Leading to Study Drug Discontinuation: OLE Phase
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: OLE: During 52 weeks of treatmentPopulation: OL safety analysis set included the participants who took \>= 1 dose of OL zavegepant, i.e., nonmissing OL zavegepant start date. Here, "Number Analyzed" signifies participants evaluable for the specified rows. "Overall Number of Participants Analyzed" contributed data to table but may not have evaluable data for every row.
Laboratory tests included eosinophils, hemoglobin, leukocytes, lymphocytes, neutrophils, platelets; albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bicarbonate, bilirubin, calcium, cholesterol, potassium, sodium, triglycerides, uric acid, urinalysis, urine protein, creatine kinase (CK), creatinine, glomerular filtration rate (GFR), glucose, glucose fasting, lactate dehydrogenase, low density lipoprotein (LDL) Cholesterol, LDL Cholesterol. Number of participants with grade 3 to 4 laboratory test abnormalities were evaluated in this outcome measure. Only rows which included at least 1 participant in any reporting group with grade 3 to 4 abnormality were reported in this outcome measure. As per Common Terminology Criteria for Adverse Events (CTCAE version 5.0) Grade 3= severe and Grade 4= life-threatening or disabling.
Outcome measures
| Measure |
Zavegepant 100 mg (DBT)
n=155 Participants
Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \*4 capsules) daily for 12 weeks in DBT phase.
|
Zavegepant 200 mg (DBT)
n=143 Participants
Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 100 mg
Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 200 mg
Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: OLE Phase
Neutrophils
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: OLE Phase
Hemoglobin
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: OLE Phase
AST
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: OLE Phase
Creatine Kinase
|
10 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: OLE Phase
Glucose fasting, low
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: OLE Phase
LDL Cholesterol
|
7 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: OLE Phase
LDL Cholesterol, fasting
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: OLE Phase
LDL Cholesterol, not fasting
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: OLE Phase
Potassium, high
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: OLE Phase
Triglycerides
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: OLE Phase
Triglycerides, fasting
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: OLE Phase
Triglycerides, not fasting
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: OLE Phase
Urinalysis
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: DBT: Over 12 weeks of treatmentPopulation: DBT safety analysis set included the participants in the who were enrolled and who took \>=1 dose of DB study drug (zavegepant or placebo), i.e., non-missing study drug start date.
Elevations of AST or alanine aminotransferase (ALT) \> 3 \*upper limit of normal (ULN) concurrent with total bilirubin (TBL) \> 2 \*ULN (elevations on the same laboratory collection date) were included.
Outcome measures
| Measure |
Zavegepant 100 mg (DBT)
n=173 Participants
Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \*4 capsules) daily for 12 weeks in DBT phase.
|
Zavegepant 200 mg (DBT)
n=175 Participants
Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
n=348 Participants
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 100 mg
n=86 Participants
Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 200 mg
n=88 Participants
Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
n=174 Participants
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With AST or ALT Elevations >3 * ULN With Total Bilirubin > 2 * ULN: DBT Phase
|
0 Percentage of participants
Interval 0.0 to 2.5
|
0 Percentage of participants
Interval 0.0 to 2.5
|
0 Percentage of participants
Interval 0.0 to 1.3
|
0 Percentage of participants
Interval 0.0 to 5.0
|
0 Percentage of participants
Interval 0.0 to 4.9
|
0 Percentage of participants
Interval 0.0 to 2.5
|
SECONDARY outcome
Timeframe: OLE: Over 52 weeks of treatmentPopulation: OL safety analysis set included the participants who took \>= 1 dose of OL zavegepant, i.e., nonmissing OL zavegepant start date.
Elevations of AST or ALT \> 3 \* ULN concurrent with TBL \> 2 \*ULN were defined as elevations on the same collection date.
Outcome measures
| Measure |
Zavegepant 100 mg (DBT)
n=155 Participants
Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \*4 capsules) daily for 12 weeks in DBT phase.
|
Zavegepant 200 mg (DBT)
n=143 Participants
Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 100 mg
Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 200 mg
Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With AST or ALT Elevations >3 * ULN With Total Bilirubin > 2 * ULN: OLE Phase
|
0 Percentage of participants
Interval 0.0 to 2.8
|
0 Percentage of participants
Interval 0.0 to 3.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: DBT Phase: During 12 weeks of treatmentPopulation: DBT safety analysis set included the participants in the who were enrolled and who took \>=1 dose of DB study drug (zavegepant or placebo), i.e., non-missing study drug start date.
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 does not necessarily have a causal relationship with this treatment. AEs by intensity: Mild: Transient and may require only minimal treatment or therapeutic intervention. Event did not interfere with activities of daily living. Moderate: Alleviated with additional specific therapeutic intervention. Event interfered with activities of daily living, causing discomfort, but possessed no significant or permanent risk of harm. Severe: Interrupted activities of daily living significantly affected clinical status or required intensive therapeutic intervention.
Outcome measures
| Measure |
Zavegepant 100 mg (DBT)
n=173 Participants
Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \*4 capsules) daily for 12 weeks in DBT phase.
|
Zavegepant 200 mg (DBT)
n=175 Participants
Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
n=348 Participants
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 100 mg
n=86 Participants
Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 200 mg
n=88 Participants
Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
n=174 Participants
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Hepatic-related AEs by Intensity: DBT Phase
Mild
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hepatic-related AEs by Intensity: DBT Phase
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hepatic-related AEs by Intensity: DBT Phase
Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: DBT Phase: During 12 weeks of treatmentPopulation: DBT safety analysis set included the participants in the who were enrolled and who took \>=1 dose of DB study drug (zavegepant or placebo), i.e., non-missing study drug start date.
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 does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Zavegepant 100 mg (DBT)
n=173 Participants
Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \*4 capsules) daily for 12 weeks in DBT phase.
|
Zavegepant 200 mg (DBT)
n=175 Participants
Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
n=348 Participants
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 100 mg
n=86 Participants
Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 200 mg
n=88 Participants
Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
n=174 Participants
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Hepatic-related AEs Leading to Study Drug Discontinuation: DBT Phase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: OLE: Over 52 weeks of treatmentPopulation: OL safety analysis set included the participants who took \>= 1 dose of OL zavegepant, i.e., nonmissing OL zavegepant start date.
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 does not necessarily have a causal relationship with this treatment. AEs by intensity: Mild: Transient and may require only minimal treatment or therapeutic intervention. Event did not interfere with activities of daily living. Moderate: Alleviated with additional specific therapeutic intervention. Event interfered with activities of daily living, causing discomfort, but possessed no significant or permanent risk of harm. Severe: Interrupted activities of daily living significantly affected clinical status or required intensive therapeutic intervention.
Outcome measures
| Measure |
Zavegepant 100 mg (DBT)
n=155 Participants
Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \*4 capsules) daily for 12 weeks in DBT phase.
|
Zavegepant 200 mg (DBT)
n=143 Participants
Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 100 mg
Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 200 mg
Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Hepatic-related AEs by Intensity: OLE Phase
Severe
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hepatic-related AEs by Intensity: OLE Phase
Mild
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hepatic-related AEs by Intensity: OLE Phase
Moderate
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: OLE: Over 52 weeks of treatmentPopulation: OL safety analysis set included the participants who took \>= 1 dose of OL zavegepant, i.e., nonmissing OL zavegepant start date.
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 does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Zavegepant 100 mg (DBT)
n=155 Participants
Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \*4 capsules) daily for 12 weeks in DBT phase.
|
Zavegepant 200 mg (DBT)
n=143 Participants
Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 100 mg
Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 200 mg
Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Hepatic-related AEs Leading to Study Drug Discontinuation: OLE Phase
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
Adverse Events
Zavegepant 100 mg (DBT)
Zavegepant 200 mg (DBT)
Zavegepant Pooled (DBT)
Placebo (DBT) Matched to Zavegepant 100 mg
Placebo (DBT) Matched to Zavegepant 200 mg
Placebo Pooled (DBT)
Zavegepant 100 mg (OLE)
Zavegepant 200 mg (OLE)
Zavegepant 100 mg DBT/Zavegepant 100 mg OLE: Follow-up
Zavegepant 200 mg DBT/ Zavegepant 200 mg OLE: Follow-up
Placebo Matched to Zavegepant 100 mg (DBT)/ Zavegepant 100 mg OLE: Follow-up
Placebo Matched to Zavegepant 200 mg (DBT)/ Zavegepant 200 mg OLE: Follow-up
Placebo Pooled (DBT)/No Zavegepant OLE: Follow-up
Serious adverse events
| Measure |
Zavegepant 100 mg (DBT)
n=173 participants at risk
Participants were randomized to receive Zavegepant 100 mg orally as soft gelatin capsules (25 mg \*4 capsules) daily for 12 weeks in DBT phase.
|
Zavegepant 200 mg (DBT)
n=175 participants at risk
Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 12 weeks in DBT phase.
|
Zavegepant Pooled (DBT)
n=348 participants at risk
Participants were randomized to receive Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 100 mg
n=86 participants at risk
Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 200 mg
n=88 participants at risk
Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
n=174 participants at risk
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
Zavegepant 100 mg (OLE)
n=155 participants at risk
Participants who received Zavegepant 100 mg orally as soft gelatin capsules (25 mg \*4 capsules) daily for 52 weeks in OLE phase.
|
Zavegepant 200 mg (OLE)
n=143 participants at risk
Participants who received Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 52 weeks in OLE phase.
|
Zavegepant 100 mg DBT/Zavegepant 100 mg OLE: Follow-up
n=154 participants at risk
Participants who received Zavegepant 100 mg in DBT phase or in DBT and OLE phases and were followed up for safety for 8 weeks post discontinuation or completion of treatment in DBT or OLE phase.
|
Zavegepant 200 mg DBT/ Zavegepant 200 mg OLE: Follow-up
n=162 participants at risk
Participants who received Zavegepant 200 mg in DBT phase or in DBT and OLE phases and were followed up for safety for 8 weeks post discontinuation or completion of treatment in DBT or OLE phase.
|
Placebo Matched to Zavegepant 100 mg (DBT)/ Zavegepant 100 mg OLE: Follow-up
n=47 participants at risk
Participants who received Placebo matched to Zavegepant 100 mg in DBT phase or Placebo matched to Zavegepant 100 mg in DBT phase and Zavegepant 100 mg in OLE phase, were followed up for safety for 8 weeks post discontinuation or completion of treatment in DBT or OLE phase.
|
Placebo Matched to Zavegepant 200 mg (DBT)/ Zavegepant 200 mg OLE: Follow-up
n=48 participants at risk
Participants who received Placebo matched to Zavegepant 200 mg in DBT phase or Placebo matched to Zavegepant 200 mg in DBT phase and Zavegepant 200 mg in OLE phase, were followed up for safety for 8 weeks post discontinuation or completion of treatment in DBT or OLE phase.
|
Placebo Pooled (DBT)/No Zavegepant OLE: Follow-up
n=70 participants at risk
Participants who received Placebo matched to Zavegepant 100 mg or 200 mg in DBT phase and no Zavegepant in OLE phase were followed up for safety for 8 weeks post discontinuation or completion of treatment in DBT phase.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/173 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.57%
1/175 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.29%
1/348 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/86 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/88 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/174 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/155 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/143 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/154 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/162 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/47 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/48 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/70 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
|
Cardiac disorders
Hypertensive heart disease
|
0.58%
1/173 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/175 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.29%
1/348 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/86 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/88 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/174 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/155 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/143 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/154 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/162 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/47 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/48 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/70 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
|
Infections and infestations
COVID-19
|
0.00%
0/173 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/175 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/348 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/86 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
1.1%
1/88 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.57%
1/174 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/155 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/143 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/154 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/162 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/47 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/48 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/70 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/173 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/175 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/348 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/86 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/88 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/174 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/155 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/143 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/154 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.62%
1/162 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/47 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/48 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/70 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/173 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/175 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/348 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/86 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/88 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/174 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/155 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/143 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/154 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/162 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
2.1%
1/47 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/48 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/70 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/173 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/175 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/348 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/86 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/88 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/174 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/155 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
1.4%
2/143 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/154 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/162 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/47 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/48 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/70 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/173 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/175 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/348 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/86 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/88 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/174 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/155 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.70%
1/143 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/154 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/162 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/47 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/48 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/70 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/173 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/175 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/348 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/86 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/88 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/174 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.65%
1/155 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/143 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/154 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/162 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/47 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/48 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/70 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/173 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/175 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/348 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/86 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/88 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/174 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/155 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.70%
1/143 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/154 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/162 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/47 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/48 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/70 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
Other adverse events
| Measure |
Zavegepant 100 mg (DBT)
n=173 participants at risk
Participants were randomized to receive Zavegepant 100 mg orally as soft gelatin capsules (25 mg \*4 capsules) daily for 12 weeks in DBT phase.
|
Zavegepant 200 mg (DBT)
n=175 participants at risk
Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 12 weeks in DBT phase.
|
Zavegepant Pooled (DBT)
n=348 participants at risk
Participants were randomized to receive Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 100 mg
n=86 participants at risk
Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.
|
Placebo (DBT) Matched to Zavegepant 200 mg
n=88 participants at risk
Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.
|
Placebo Pooled (DBT)
n=174 participants at risk
Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.
|
Zavegepant 100 mg (OLE)
n=155 participants at risk
Participants who received Zavegepant 100 mg orally as soft gelatin capsules (25 mg \*4 capsules) daily for 52 weeks in OLE phase.
|
Zavegepant 200 mg (OLE)
n=143 participants at risk
Participants who received Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 52 weeks in OLE phase.
|
Zavegepant 100 mg DBT/Zavegepant 100 mg OLE: Follow-up
n=154 participants at risk
Participants who received Zavegepant 100 mg in DBT phase or in DBT and OLE phases and were followed up for safety for 8 weeks post discontinuation or completion of treatment in DBT or OLE phase.
|
Zavegepant 200 mg DBT/ Zavegepant 200 mg OLE: Follow-up
n=162 participants at risk
Participants who received Zavegepant 200 mg in DBT phase or in DBT and OLE phases and were followed up for safety for 8 weeks post discontinuation or completion of treatment in DBT or OLE phase.
|
Placebo Matched to Zavegepant 100 mg (DBT)/ Zavegepant 100 mg OLE: Follow-up
n=47 participants at risk
Participants who received Placebo matched to Zavegepant 100 mg in DBT phase or Placebo matched to Zavegepant 100 mg in DBT phase and Zavegepant 100 mg in OLE phase, were followed up for safety for 8 weeks post discontinuation or completion of treatment in DBT or OLE phase.
|
Placebo Matched to Zavegepant 200 mg (DBT)/ Zavegepant 200 mg OLE: Follow-up
n=48 participants at risk
Participants who received Placebo matched to Zavegepant 200 mg in DBT phase or Placebo matched to Zavegepant 200 mg in DBT phase and Zavegepant 200 mg in OLE phase, were followed up for safety for 8 weeks post discontinuation or completion of treatment in DBT or OLE phase.
|
Placebo Pooled (DBT)/No Zavegepant OLE: Follow-up
n=70 participants at risk
Participants who received Placebo matched to Zavegepant 100 mg or 200 mg in DBT phase and no Zavegepant in OLE phase were followed up for safety for 8 weeks post discontinuation or completion of treatment in DBT phase.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.58%
1/173 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
1.1%
2/175 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.86%
3/348 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
1.2%
1/86 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
5.7%
5/88 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
3.4%
6/174 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/155 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/143 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/154 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/162 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/47 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/48 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/70 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
|
Gastrointestinal disorders
Nausea
|
6.9%
12/173 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
2.9%
5/175 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
4.9%
17/348 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
9.3%
8/86 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
5.7%
5/88 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
7.5%
13/174 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/155 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/143 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/154 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/162 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/47 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/48 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/70 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
|
Infections and infestations
Urinary tract infection
|
1.2%
2/173 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.57%
1/175 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.86%
3/348 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
7.0%
6/86 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
1.1%
1/88 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
4.0%
7/174 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/155 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/143 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/154 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/162 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/47 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/48 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/70 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
|
Infections and infestations
COVID-19
|
0.00%
0/173 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/175 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/348 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/86 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/88 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/174 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
7.7%
12/155 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
8.4%
12/143 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/154 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/162 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/47 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/48 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
0.00%
0/70 • DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
|
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