Trial Outcomes & Findings for Initiating Early Control of Migraine Pain and Associated Symptoms (NCT NCT04163185)
NCT ID: NCT04163185
Last Updated: 2026-01-28
Results Overview
Absence of headache pain at Hour 2
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
302 participants
Primary outcome timeframe
Hour 2
Results posted on
2026-01-28
Participant Flow
Participant milestones
| Measure |
AXS-07
Taken once upon the onset of migraine
AXS-07 (MoSEIC meloxicam and rizatriptan): AXS-07 tablet taken once upon the earliest onset of migraine pain.
|
Placebo
Taken once upon the onset of migraine
Placebo: Placebo tablet taken once upon the earliest onset of migraine pain.
|
|---|---|---|
|
Overall Study
STARTED
|
152
|
150
|
|
Overall Study
Safety Population
|
140
|
143
|
|
Overall Study
ITT Population
|
132
|
135
|
|
Overall Study
COMPLETED
|
140
|
143
|
|
Overall Study
NOT COMPLETED
|
12
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Initiating Early Control of Migraine Pain and Associated Symptoms
Baseline characteristics by cohort
| Measure |
AXS-07
n=140 Participants
Taken once upon the onset of migraine
AXS-07 (MoSEIC meloxicam and rizatriptan): AXS-07 tablet taken once upon the earliest onset of migraine pain.
|
Placebo
n=143 Participants
Taken once upon the onset of migraine
Placebo: Placebo tablet taken once upon the earliest onset of migraine pain.
|
Total
n=283 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.7 years
STANDARD_DEVIATION 11.58 • n=41 Participants
|
41.4 years
STANDARD_DEVIATION 10.67 • n=1581 Participants
|
41.6 years
STANDARD_DEVIATION 11.11 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
119 Participants
n=41 Participants
|
122 Participants
n=1581 Participants
|
241 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=41 Participants
|
21 Participants
n=1581 Participants
|
42 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=41 Participants
|
7 Participants
n=1581 Participants
|
8 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
18 Participants
n=41 Participants
|
17 Participants
n=1581 Participants
|
35 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
White
|
118 Participants
n=41 Participants
|
116 Participants
n=1581 Participants
|
234 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: Hour 2Population: ITT Population
Absence of headache pain at Hour 2
Outcome measures
| Measure |
AXS-07
n=132 Participants
Taken once upon migraine
AXS-07 (MoSEIC meloxicam and rizatriptan): AXS-07 tablet taken once upon the earliest onset of migraine pain.
|
Placebo
n=135 Participants
Taken once upon migraine
Placebo: Placebo tablet taken once upon the earliest onset of migraine pain.
|
|---|---|---|
|
Percentage of Subjects Achieving Headache Pain Freedom at Hour 2
|
43 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: Hour 2Population: ITT Population
Absence of Most Bothersome Symptom, defined at the onset of migraine at Hour 2
Outcome measures
| Measure |
AXS-07
n=132 Participants
Taken once upon migraine
AXS-07 (MoSEIC meloxicam and rizatriptan): AXS-07 tablet taken once upon the earliest onset of migraine pain.
|
Placebo
n=135 Participants
Taken once upon migraine
Placebo: Placebo tablet taken once upon the earliest onset of migraine pain.
|
|---|---|---|
|
Percentage of Subjects With Absence of Most Bothersome Symptom at Hour 2
|
58 Participants
|
36 Participants
|
Adverse Events
AXS-07
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AXS-07
n=140 participants at risk
Taken once upon migraine
AXS-07 (MoSEIC meloxicam and rizatriptan): AXS-07 tablet taken once upon the earliest onset of migraine pain.
|
Placebo
n=143 participants at risk
Taken once upon migraine
Placebo: Placebo tablet taken once upon the earliest onset of migraine pain.
|
|---|---|---|
|
Nervous system disorders
Somnolence
|
4.3%
6/140 • Adverse events were collected on or after the dosing date and included any new event or ongoing event that worsened in severity after the date of dosing. Adverse events were collected up to 5 days after the last study visit, up to 12 days per participant.
Safety Population
|
2.1%
3/143 • Adverse events were collected on or after the dosing date and included any new event or ongoing event that worsened in severity after the date of dosing. Adverse events were collected up to 5 days after the last study visit, up to 12 days per participant.
Safety Population
|
|
Nervous system disorders
Dizziness
|
2.9%
4/140 • Adverse events were collected on or after the dosing date and included any new event or ongoing event that worsened in severity after the date of dosing. Adverse events were collected up to 5 days after the last study visit, up to 12 days per participant.
Safety Population
|
1.4%
2/143 • Adverse events were collected on or after the dosing date and included any new event or ongoing event that worsened in severity after the date of dosing. Adverse events were collected up to 5 days after the last study visit, up to 12 days per participant.
Safety Population
|
|
Nervous system disorders
Paraesthesia
|
2.1%
3/140 • Adverse events were collected on or after the dosing date and included any new event or ongoing event that worsened in severity after the date of dosing. Adverse events were collected up to 5 days after the last study visit, up to 12 days per participant.
Safety Population
|
0.00%
0/143 • Adverse events were collected on or after the dosing date and included any new event or ongoing event that worsened in severity after the date of dosing. Adverse events were collected up to 5 days after the last study visit, up to 12 days per participant.
Safety Population
|
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