Trial Outcomes & Findings for Maximizing Outcomes in Treating Acute Migraine (NCT NCT03896009)
NCT ID: NCT03896009
Last Updated: 2023-08-24
Results Overview
Absence of headache pain. AXS-07 vs Placebo.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1594 participants
Primary outcome timeframe
Hour 2 following dose administration
Results posted on
2023-08-24
Participant Flow
Participant milestones
| Measure |
AXS-07
Taken once upon a qualifying migraine
AXS-07 (MoSEIC meloxicam and rizatriptan): AXS-07 taken once upon onset of a qualifying migraine.
|
Meloxicam
Taken once upon a qualifying migraine
Meloxicam: Meloxicam taken once upon onset of a qualifying migraine.
|
Rizatriptan
Taken once upon a qualifying migraine
Rizatriptan: Rizatriptan taken once upon onset of a qualifying migraine.
|
Placebo
Taken once upon a qualifying migraine
Placebo: Placebo taken once upon onset of a qualifying migraine.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
456
|
455
|
456
|
227
|
|
Overall Study
COMPLETED
|
441
|
433
|
434
|
218
|
|
Overall Study
NOT COMPLETED
|
15
|
22
|
22
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Maximizing Outcomes in Treating Acute Migraine
Baseline characteristics by cohort
| Measure |
AXS-07
n=441 Participants
Taken once upon a qualifying migraine
AXS-07 (MoSEIC meloxicam and rizatriptan): AXS-07 taken once upon onset of a qualifying migraine.
|
Meloxicam
n=433 Participants
Taken once upon a qualifying migraine
Meloxicam: Meloxicam taken once upon onset of a qualifying migraine.
|
Rizatriptan
n=434 Participants
Taken once upon a qualifying migraine
Rizatriptan: Rizatriptan taken once upon onset of a qualifying migraine.
|
Placebo
n=218 Participants
Taken once upon a qualifying migraine
Placebo: Placebo taken once upon onset of a qualifying migraine.
|
Total
n=1526 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
41.1 years
STANDARD_DEVIATION 11.64 • n=5 Participants
|
41.0 years
STANDARD_DEVIATION 12.13 • n=7 Participants
|
41.5 years
STANDARD_DEVIATION 10.75 • n=5 Participants
|
41.0 years
STANDARD_DEVIATION 11.71 • n=4 Participants
|
41.1 years
STANDARD_DEVIATION 11.54 • n=21 Participants
|
|
Sex: Female, Male
Female
|
357 Participants
n=5 Participants
|
363 Participants
n=7 Participants
|
366 Participants
n=5 Participants
|
185 Participants
n=4 Participants
|
1271 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
255 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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)
Black or African American
|
76 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
296 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
345 Participants
n=5 Participants
|
330 Participants
n=7 Participants
|
332 Participants
n=5 Participants
|
160 Participants
n=4 Participants
|
1167 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Hour 2 following dose administrationPopulation: ITT population consists of all randomized subjects who received study drug and had a qualifying migraine.
Absence of headache pain. AXS-07 vs Placebo.
Outcome measures
| Measure |
AXS-07
n=428 Participants
Taken once upon a qualifying migraine
AXS-07 (MoSEIC meloxicam and rizatriptan): AXS-07 taken once upon onset of a qualifying migraine.
|
Placebo
n=209 Participants
Taken once upon a qualifying migraine
Placebo: Placebo taken once upon onset of a qualifying migraine.
|
|---|---|---|
|
Percentage of Subjects Reporting Headache Pain Freedom
|
85 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: Hour 2 following dose administrationPopulation: ITT population consists of all randomized subjects who received study drug and had a qualifying migraine.
Absence of most bothersome symptom, defined at the onset of migraine. AXS-07 vs Placebo.
Outcome measures
| Measure |
AXS-07
n=428 Participants
Taken once upon a qualifying migraine
AXS-07 (MoSEIC meloxicam and rizatriptan): AXS-07 taken once upon onset of a qualifying migraine.
|
Placebo
n=209 Participants
Taken once upon a qualifying migraine
Placebo: Placebo taken once upon onset of a qualifying migraine.
|
|---|---|---|
|
Percentage of Subjects With Absence of Most Bothersome Symptom
|
158 Participants
|
51 Participants
|
Adverse Events
AXS-07
Serious events: 1 serious events
Other events: 49 other events
Deaths: 0 deaths
Meloxicam
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Rizatriptan
Serious events: 0 serious events
Other events: 67 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AXS-07
n=441 participants at risk
Taken once upon a qualifying migraine
AXS-07 (MoSEIC meloxicam and rizatriptan): AXS-07 taken once upon onset of a qualifying migraine.
|
Meloxicam
n=433 participants at risk
Taken once upon a qualifying migraine
Meloxicam: Meloxicam taken once upon onset of a qualifying migraine.
|
Rizatriptan
n=434 participants at risk
Taken once upon a qualifying migraine
Rizatriptan: Rizatriptan taken once upon onset of a qualifying migraine.
|
Placebo
n=218 participants at risk
Taken once upon a qualifying migraine
Placebo: Placebo taken once upon onset of a qualifying migraine.
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.23%
1/441 • Number of events 1 • Adverse events were collected after administration of study drug through the final visit (up to 1 week). Any AE was monitored up to a maximum of 30 days after the final visit.
Safety Population includes all subjects who received study drug.
|
0.00%
0/433 • Adverse events were collected after administration of study drug through the final visit (up to 1 week). Any AE was monitored up to a maximum of 30 days after the final visit.
Safety Population includes all subjects who received study drug.
|
0.00%
0/434 • Adverse events were collected after administration of study drug through the final visit (up to 1 week). Any AE was monitored up to a maximum of 30 days after the final visit.
Safety Population includes all subjects who received study drug.
|
0.00%
0/218 • Adverse events were collected after administration of study drug through the final visit (up to 1 week). Any AE was monitored up to a maximum of 30 days after the final visit.
Safety Population includes all subjects who received study drug.
|
Other adverse events
| Measure |
AXS-07
n=441 participants at risk
Taken once upon a qualifying migraine
AXS-07 (MoSEIC meloxicam and rizatriptan): AXS-07 taken once upon onset of a qualifying migraine.
|
Meloxicam
n=433 participants at risk
Taken once upon a qualifying migraine
Meloxicam: Meloxicam taken once upon onset of a qualifying migraine.
|
Rizatriptan
n=434 participants at risk
Taken once upon a qualifying migraine
Rizatriptan: Rizatriptan taken once upon onset of a qualifying migraine.
|
Placebo
n=218 participants at risk
Taken once upon a qualifying migraine
Placebo: Placebo taken once upon onset of a qualifying migraine.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
2.7%
12/441 • Number of events 12 • Adverse events were collected after administration of study drug through the final visit (up to 1 week). Any AE was monitored up to a maximum of 30 days after the final visit.
Safety Population includes all subjects who received study drug.
|
3.2%
14/433 • Number of events 15 • Adverse events were collected after administration of study drug through the final visit (up to 1 week). Any AE was monitored up to a maximum of 30 days after the final visit.
Safety Population includes all subjects who received study drug.
|
4.8%
21/434 • Number of events 21 • Adverse events were collected after administration of study drug through the final visit (up to 1 week). Any AE was monitored up to a maximum of 30 days after the final visit.
Safety Population includes all subjects who received study drug.
|
3.7%
8/218 • Number of events 8 • Adverse events were collected after administration of study drug through the final visit (up to 1 week). Any AE was monitored up to a maximum of 30 days after the final visit.
Safety Population includes all subjects who received study drug.
|
|
Nervous system disorders
Dizziness
|
1.6%
7/441 • Number of events 7 • Adverse events were collected after administration of study drug through the final visit (up to 1 week). Any AE was monitored up to a maximum of 30 days after the final visit.
Safety Population includes all subjects who received study drug.
|
1.2%
5/433 • Number of events 5 • Adverse events were collected after administration of study drug through the final visit (up to 1 week). Any AE was monitored up to a maximum of 30 days after the final visit.
Safety Population includes all subjects who received study drug.
|
2.1%
9/434 • Number of events 9 • Adverse events were collected after administration of study drug through the final visit (up to 1 week). Any AE was monitored up to a maximum of 30 days after the final visit.
Safety Population includes all subjects who received study drug.
|
0.92%
2/218 • Number of events 2 • Adverse events were collected after administration of study drug through the final visit (up to 1 week). Any AE was monitored up to a maximum of 30 days after the final visit.
Safety Population includes all subjects who received study drug.
|
|
Nervous system disorders
Somnolence
|
1.4%
6/441 • Number of events 6 • Adverse events were collected after administration of study drug through the final visit (up to 1 week). Any AE was monitored up to a maximum of 30 days after the final visit.
Safety Population includes all subjects who received study drug.
|
2.3%
10/433 • Number of events 10 • Adverse events were collected after administration of study drug through the final visit (up to 1 week). Any AE was monitored up to a maximum of 30 days after the final visit.
Safety Population includes all subjects who received study drug.
|
2.1%
9/434 • Number of events 9 • Adverse events were collected after administration of study drug through the final visit (up to 1 week). Any AE was monitored up to a maximum of 30 days after the final visit.
Safety Population includes all subjects who received study drug.
|
0.46%
1/218 • Number of events 1 • Adverse events were collected after administration of study drug through the final visit (up to 1 week). Any AE was monitored up to a maximum of 30 days after the final visit.
Safety Population includes all subjects who received study drug.
|
|
General disorders
All Others, occurring in <1% of Subjects
|
6.3%
28/441 • Adverse events were collected after administration of study drug through the final visit (up to 1 week). Any AE was monitored up to a maximum of 30 days after the final visit.
Safety Population includes all subjects who received study drug.
|
5.1%
22/433 • Adverse events were collected after administration of study drug through the final visit (up to 1 week). Any AE was monitored up to a maximum of 30 days after the final visit.
Safety Population includes all subjects who received study drug.
|
7.4%
32/434 • Adverse events were collected after administration of study drug through the final visit (up to 1 week). Any AE was monitored up to a maximum of 30 days after the final visit.
Safety Population includes all subjects who received study drug.
|
0.92%
2/218 • Adverse events were collected after administration of study drug through the final visit (up to 1 week). Any AE was monitored up to a maximum of 30 days after the final visit.
Safety Population includes all subjects who received study drug.
|
Additional Information
Caroline Streicher, Executive Director, Clinical Operations
Axsome Therapeutics, Inc.
Phone: 212-332-5061
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place