Trial Outcomes & Findings for Randomized Trial in Adult Participants With Acute Migraines (NCT NCT04571060)

NCT ID: NCT04571060

Last Updated: 2023-04-24

Results Overview

Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the electronic clinical outcome assessment (eCOA) handheld device. Pain freedom was defined as pain level of none post-dose.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1978 participants
• Primary outcome timeframe: 2 hours post-dose
• Results posted on: 2023-04-24

Participant Flow

Participants were enrolled at 90 sites in the United States.

A total of 1978 participants were enrolled, of which 1405 participants were randomized to zavegepant 10 mg dose group or placebo group. The randomization was stratified by the use of prophylactic migraine medication (yes or no). 573 participants were not randomized due to screen failure, lost to follow-up, non-compliance, or other reasons.

Participant milestones

Measure	Zavegepant 10 mg Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar Unidose System (UDS) liquid spray device.	Placebo Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.
Overall Study STARTED	703	702
Overall Study Treated	629	653
Overall Study Efficacy Analysis Set Participants	623	646
Overall Study COMPLETED	622	653
Overall Study NOT COMPLETED	81	49

Reasons for withdrawal

Measure	Zavegepant 10 mg Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar Unidose System (UDS) liquid spray device.	Placebo Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.
Overall Study Lost to Follow-up from Randomization to Treatment	17	9
Overall Study Never treated migraine	47	36
Overall Study Protocol Violation	4	2
Overall Study Withdrawal by Subject	6	2
Overall Study Lost to Follow-up from Treatment to End of Study	7	0

Baseline Characteristics

Randomized Trial in Adult Participants With Acute Migraines

Baseline characteristics by cohort

Measure	Zavegepant 10 mg n=629 Participants Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.	Placebo n=653 Participants Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.	Total n=1282 Participants Total of all reporting groups
Age, Continuous	40.9 years STANDARD_DEVIATION 13.19 • n=5 Participants	40.7 years STANDARD_DEVIATION 13.46 • n=7 Participants	40.8 years STANDARD_DEVIATION 13.32 • n=5 Participants
Sex: Female, Male Female	508 Participants n=5 Participants	551 Participants n=7 Participants	1059 Participants n=5 Participants
Sex: Female, Male Male	121 Participants n=5 Participants	102 Participants n=7 Participants	223 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	114 Participants n=5 Participants	146 Participants n=7 Participants	260 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	515 Participants n=5 Participants	507 Participants n=7 Participants	1022 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	21 Participants n=5 Participants	16 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	86 Participants n=5 Participants	84 Participants n=7 Participants	170 Participants n=5 Participants
Race (NIH/OMB) White	515 Participants n=5 Participants	545 Participants n=7 Participants	1060 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Prophylactic Migraine Medication Use at Randomization Yes	88 Participants n=5 Participants	83 Participants n=7 Participants	171 Participants n=5 Participants
Prophylactic Migraine Medication Use at Randomization No	541 Participants n=5 Participants	570 Participants n=7 Participants	1111 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hours post-dose

Population: Efficacy Analysis Participants included treated participants who were randomized only once, had moderate to severe pain at the time of dosing, and had non-missing, post-dose efficacy data.

Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the electronic clinical outcome assessment (eCOA) handheld device. Pain freedom was defined as pain level of none post-dose.

Outcome measures

Measure	Zavegepant 10 mg n=623 Participants Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.	Placebo n=646 Participants Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.
Percentage of Participants With Freedom From Pain at 2 Hours Post-dose	23.6 Percentage of participants Interval 20.3 to 26.9	14.9 Percentage of participants Interval 12.1 to 17.6

PRIMARY outcome

Timeframe: 2 hours post-dose

Population: Efficacy Analysis Participants included treated participants who were randomized only once, had moderate to severe pain at the time of dosing, and had non-missing, post-dose efficacy data.

MBS was reported as nausea, photophobia, or phonophobia immediately before dosing using the eCOA handheld device. Symptom status (absent, present) was assessed post-dose using the eCOA handheld device separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at on-study migraine attack onset that was absent post-dose.

Outcome measures

Measure	Zavegepant 10 mg n=623 Participants Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.	Placebo n=646 Participants Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.
Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose	39.6 Percentage of participants Interval 35.8 to 43.5	31.1 Percentage of participants Interval 27.5 to 34.7

SECONDARY outcome

Timeframe: 2 hours post-dose

Population: Efficacy analysis participants were analyzed.

Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Pain relief was defined as pain level of none or mild.

Outcome measures

Measure	Zavegepant 10 mg n=623 Participants Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.	Placebo n=646 Participants Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.
Percentage of Participants With Pain Relief at 2 Hours Post-dose	58.7 Percentage of participants Interval 54.9 to 62.6	49.7 Percentage of participants Interval 45.8 to 53.5

SECONDARY outcome

Timeframe: 2 hours post-dose

Population: The Efficacy Analysis Participants with functional disability at the time of dosing were analyzed.

Functional disability level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) at on-study migraine attack onset.

Outcome measures

Measure	Zavegepant 10 mg n=570 Participants Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.	Placebo n=593 Participants Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.
Percentage of Participants Who Were Able to Function Normally at 2 Hours Post-dose	35.8 Percentage of participants Interval 31.9 to 39.7	25.6 Percentage of participants Interval 22.1 to 29.1

SECONDARY outcome

Timeframe: From 2 to 24 hours post-dose

Population: Efficacy analysis participants were analyzed.

Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 24 hours post-dose.

Outcome measures

Measure	Zavegepant 10 mg n=623 Participants Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.	Placebo n=646 Participants Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.
Percentage of Participants With Sustained Pain Relief From 2 Hours to 24 Post-dose	40.6 Percentage of participants Interval 36.8 to 44.5	33.0 Percentage of participants Interval 29.3 to 36.6

SECONDARY outcome

Timeframe: From 2 to 48 hours post-dose

Population: Efficacy analysis participants were analyzed.

Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 48 hours post-dose.

Outcome measures

Measure	Zavegepant 10 mg n=623 Participants Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.	Placebo n=646 Participants Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.
Percentage of Participants With Sustained Pain Relief From 2 Hours to 48 Post-dose	36.1 Percentage of participants Interval 32.3 to 39.9	29.6 Percentage of participants Interval 26.0 to 33.1

SECONDARY outcome

Timeframe: From 2 to 24 hours post-dose

Population: Efficacy analysis participants were analyzed.

Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Sustained pain freedom was defined as pain level of none at 2 hours up to 24 hours post-dose.

Outcome measures

Measure	Zavegepant 10 mg n=623 Participants Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.	Placebo n=646 Participants Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.
Percentage of Participants With Sustained Pain Freedom From 2 Hours to 24 Post-dose	14.6 Percentage of participants Interval 11.8 to 17.4	9.8 Percentage of participants Interval 7.5 to 12.0

SECONDARY outcome

Timeframe: From 2 to 48 hours post-dose

Population: Efficacy analysis participants were analyzed.

Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Sustained pain freedom was defined as pain level of none at 2 hours up to 48 hours post-dose.

Outcome measures

Measure	Zavegepant 10 mg n=623 Participants Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.	Placebo n=646 Participants Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.
Percentage of Participants With Sustained Pain Freedom From 2 Hours to 48 Post-dose	12.4 Percentage of participants Interval 9.8 to 14.9	8.7 Percentage of participants Interval 6.5 to 10.8

SECONDARY outcome

Timeframe: 2 hours post-dose

Population: Efficacy Analysis Participants with symptom of phonophobia present at the time of dosing were analyzed.

Phonophobia (sensitivity to sound) status was measured as absent or present in the eCOA handheld device. Freedom from phonophobia was defined as phonophobia absent post-dose in the subset of participants with phonophobia present at on-study migraine attack onset.

Outcome measures

Measure	Zavegepant 10 mg n=407 Participants Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.	Placebo n=425 Participants Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.
Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose	41.0 Percentage of participants Interval 36.3 to 45.8	32.7 Percentage of participants Interval 28.2 to 37.2

SECONDARY outcome

Timeframe: 2 hours post-dose

Population: Efficacy Analysis Participants with symptom of photophobia present at the time of dosing were analyzed.

Photophobia (sensitivity to light) status was measured as absent or present in the eCOA handheld device. Freedom from photophobia was defined as photophobia absent post-dose in the subset of participants with photophobia present at on-study migraine attack onset.

Outcome measures

Measure	Zavegepant 10 mg n=558 Participants Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.	Placebo n=585 Participants Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.
Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose	37.1 Percentage of participants Interval 33.1 to 41.1	28.5 Percentage of participants Interval 24.9 to 32.2

SECONDARY outcome

Timeframe: 60 minutes post-dose

Population: Efficacy analysis participants were analyzed.

Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Pain relief was defined as pain level of none or mild.

Outcome measures

Measure	Zavegepant 10 mg n=623 Participants Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.	Placebo n=646 Participants Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.
Percentage of Participants With Pain Relief at 60 Minutes Post-dose	43.3 Percentage of participants Interval 39.4 to 47.2	37.3 Percentage of participants Interval 33.6 to 41.0

SECONDARY outcome

Timeframe: 60 minutes post-dose

Population: The Efficacy Analysis Participants with normal function at the time of dosing were analyzed.

Functional disability level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) present at on-study migraine attack onset.

Outcome measures

Measure	Zavegepant 10 mg n=570 Participants Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.	Placebo n=593 Participants Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.
Percentage of Participants Who Were Able to Function Normally at 60 Minutes Post-dose	20.2 Percentage of participants Interval 16.9 to 23.5	15.5 Percentage of participants Interval 12.6 to 18.4

SECONDARY outcome

Timeframe: 30 minutes post-dose

Population: Efficacy analysis participants were analyzed.

Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Pain relief was defined as pain level of none or mild.

Outcome measures

Measure	Zavegepant 10 mg n=623 Participants Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.	Placebo n=646 Participants Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.
Percentage of Participants With Pain Relief at 30 Minutes Post-dose	30.5 Percentage of participants Interval 26.9 to 34.1	20.3 Percentage of participants Interval 17.2 to 23.4

SECONDARY outcome

Timeframe: 30 minutes post-dose

Population: The Efficacy Analysis Participants with normal function at the time of dosing were analyzed.

Functional disability level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) at on-study migraine attack onset.

Outcome measures

Measure	Zavegepant 10 mg n=570 Participants Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.	Placebo n=593 Participants Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.
Percentage of Participants Who Were Able to Function Normally at 30 Minutes Post-dose	10.5 Percentage of participants Interval 8.0 to 13.0	6.1 Percentage of participants Interval 4.1 to 8.0

SECONDARY outcome

Timeframe: 15 minutes post-dose

Population: Efficacy analysis participants were analyzed.

Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Pain relief was defined as pain level of none or mild.

Outcome measures

Measure	Zavegepant 10 mg n=623 Participants Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.	Placebo n=646 Participants Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.
Percentage of Participants With Pain Relief at 15 Minutes Post-dose	15.9 Percentage of participants Interval 13.0 to 18.8	8.0 Percentage of participants Interval 6.0 to 10.1

SECONDARY outcome

Timeframe: 15 minutes post-dose

Population: The Efficacy Analysis Participants with normal function at the time of dosing were analyzed.

Functional disability level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) at on-study migraine attack onset.

Outcome measures

Measure	Zavegepant 10 mg n=570 Participants Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.	Placebo n=593 Participants Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.
Percentage of Participants Who Were Able to Function Normally at 15 Minutes Post-dose	3.3 Percentage of participants Interval 1.9 to 4.8	2.0 Percentage of participants Interval 0.9 to 3.2

SECONDARY outcome

Timeframe: Through 24 hours post-dose

Population: Efficacy Analysis Participants were analyzed. Participants with rescue medication start date less than or equal to (≤) study drug start date + 1 day and missing rescue medication start time were excluded.

Participants who did not experience relief of their migraine headache at the end of 2 hours after dosing with study medication (and after the 2-hour assessments had been completed on the eCOA handheld device) were permitted to use the following rescue medications: aspirin, ibuprofen, acetaminophen up to 1000 mg/day (this includes Excedrin® Migraine), naproxen (or any other type of nonsteroidal anti-inflammatory drug), antiemetics (for example, metoclopramide or promethazine), or baclofen. The participant's use of rescue medication was recorded by the site on a case report form.

Outcome measures

Measure	Zavegepant 10 mg n=620 Participants Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.	Placebo n=643 Participants Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.
Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose	29.7 Percentage of participants Interval 26.1 to 33.3	35.8 Percentage of participants Interval 32.1 to 39.5

SECONDARY outcome

Timeframe: 2 hours post-dose

Population: The Efficacy Analysis Participants with symptom of nausea present at the time of dosing were analyzed.

Nausea status was measured as absent or present in the eCOA handheld device. Freedom from nausea was defined as nausea absent post-dose in the subset of participants with nausea present at on-study migraine attack onset.

Outcome measures

Measure	Zavegepant 10 mg n=380 Participants Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.	Placebo n=405 Participants Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.
Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose	52.4 Percentage of participants Interval 47.3 to 57.4	50.9 Percentage of participants Interval 46.0 to 55.7

SECONDARY outcome

Timeframe: From 2 hours to 48 hours post-dose

Population: The Efficacy Analysis Participants with pain freedom at 2 hours post-dose were analyzed.

Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Pain relapse was defined as pain level of mild, moderate, or severe after 2 hours up to 48 hours post-dose in the subset of participants with pain level of none at 2 hours post-dose.

Outcome measures

Measure	Zavegepant 10 mg n=147 Participants Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.	Placebo n=96 Participants Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.
Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose	40.8 Percentage of participants Interval 32.9 to 48.8	35.4 Percentage of participants Interval 25.8 to 45.0

Adverse Events

Zavegepant 10 mg

Serious events: 0 serious events

Other events: 129 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Zavegepant 10 mg n=629 participants at risk Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.	Placebo n=653 participants at risk Participants administered a single intranasal dose of zavegepant-matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.
Nervous system disorders Dysgeusia	20.5% 129/629 • Adverse events were assessed from study drug dosing up to the end of the study (up to 55 days). Treated Participants included enrolled participants who took study therapy (zavegepant or placebo).	4.7% 31/653 • Adverse events were assessed from study drug dosing up to the end of the study (up to 55 days). Treated Participants included enrolled participants who took study therapy (zavegepant or placebo).

Additional Information

Chief Medical Officer

Biohaven Pharmaceuticals, Inc.

Phone: 203-404-0410

Email: clinicaltrials@biohavenpharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60