Trial · NCT04163185

Initiating Early Control of Migraine Pain and Associated Symptoms

NCT04163185, Phase 3, Completed, Axsome Therapeutics, Inc.; results first posted 2026-01-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Initiating Early Control of Migraine Pain and Associated Symptoms. Trials, record NCT04163185. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04163185

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Initiating Early Control of Migraine Pain and Associated Symptoms
NCT number: NCT04163185
Status: Completed
Phases: Phase 3
Enrollment: 302 participants, actual
Lead sponsor: Axsome Therapeutics, Inc.
Conditions: Migraine
Interventions: AXS-07 (MoSEIC meloxicam and rizatriptan), Placebo
First posted: 2019-11-14
Last updated: 2026-01-28
Results first posted: 2026-01-28

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Subjects Achieving Headache Pain Freedom at Hour 2	Hour 2	Absence of headache pain at Hour 2
Primary	Percentage of Subjects With Absence of Most Bothersome Symptom at Hour 2	Hour 2	Absence of Most Bothersome Symptom, defined at the onset of migraine at Hour 2

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Subjects Achieving Headache Pain Freedom at Hour 2	Hour 2	ITT Population	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Percentage of Subjects With Absence of Most Bothersome Symptom at Hour 2	Hour 2	ITT Population	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Percentage of Subjects Achieving Headache Pain Freedom at Hour 2	AXS-07	43	Participants
Percentage of Subjects Achieving Headache Pain Freedom at Hour 2	Placebo	22	Participants
Percentage of Subjects With Absence of Most Bothersome Symptom at Hour 2	AXS-07	58	Participants
Percentage of Subjects With Absence of Most Bothersome Symptom at Hour 2	Placebo	36	Participants

Source ClinicalTrials.gov

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	AXS-07	152
Overall Study	STARTED	Placebo	150
Overall Study	Safety Population	AXS-07	140
Overall Study	Safety Population	Placebo	143
Overall Study	ITT Population	AXS-07	132
Overall Study	ITT Population	Placebo	135
Overall Study	COMPLETED	AXS-07	140
Overall Study	COMPLETED	Placebo	143
Overall Study	NOT COMPLETED	AXS-07	12
Overall Study	NOT COMPLETED	Placebo	7

Source ClinicalTrials.gov

Adverse events6

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Somnolence	Nervous system disorders	AXS-07	6	140
other	Somnolence	Nervous system disorders	Placebo	3	143
other	Dizziness	Nervous system disorders	AXS-07	4	140
other	Dizziness	Nervous system disorders	Placebo	2	143
other	Paraesthesia	Nervous system disorders	AXS-07	3	140
other	Paraesthesia	Nervous system disorders	Placebo	0	143

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AXS-07	0	140
Total, all-cause mortality	Placebo	0	143
Total, other adverse events	AXS-07	13	140
Total, other adverse events	Placebo	5	143
Total, serious adverse events	AXS-07	0	140
Total, serious adverse events	Placebo	0	143

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
AXS-07 vs Placebo: Percentage of Subjects Achieving Headache Pain Freedom at Hour 2	Trial comparisons
AXS-07 vs Placebo: deaths from any cause	Trial comparisons
AXS-07 vs Placebo: Percentage of Subjects With Absence of Most Bothersome Symptom at Hour 2	Trial comparisons
AXS-07 vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04163185

GET https://conductscience.org/api/trials/v1/NCT04163185/registered

API reference For AI assistants