Trial · NCT03896009

Maximizing Outcomes in Treating Acute Migraine

NCT03896009, Phase 3, Completed, Axsome Therapeutics, Inc.; results first posted 2023-08-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Maximizing Outcomes in Treating Acute Migraine. Trials, record NCT03896009. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03896009

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Trial

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

Title: Maximizing Outcomes in Treating Acute Migraine
NCT number: NCT03896009
Status: Completed
Phases: Phase 3
Enrollment: 1,594 participants, actual
Lead sponsor: Axsome Therapeutics, Inc.
Conditions: Migraine
Interventions: AXS-07 (MoSEIC meloxicam and rizatriptan), Meloxicam, Rizatriptan, Placebo
First posted: 2019-03-29
Last updated: 2023-08-24
Results first posted: 2023-08-24

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 Reporting Headache Pain Freedom	Hour 2 following dose administration	Absence of headache pain. AXS-07 vs Placebo.
Primary	Percentage of Subjects With Absence of Most Bothersome Symptom	Hour 2 following dose administration	Absence of most bothersome symptom, defined at the onset of migraine. AXS-07 vs Placebo.

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 Reporting Headache Pain Freedom	Hour 2 following dose administration	ITT population consists of all randomized subjects who received study drug and had a qualifying migraine.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Percentage of Subjects With Absence of Most Bothersome Symptom	Hour 2 following dose administration	ITT population consists of all randomized subjects who received study drug and had a qualifying migraine.	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 Reporting Headache Pain Freedom	AXS-07	85	Participants
Percentage of Subjects Reporting Headache Pain Freedom	Placebo	14	Participants
Percentage of Subjects With Absence of Most Bothersome Symptom	AXS-07	158	Participants
Percentage of Subjects With Absence of Most Bothersome Symptom	Placebo	51	Participants

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	AXS-07	456
Overall Study	STARTED	Meloxicam	455
Overall Study	STARTED	Rizatriptan	456
Overall Study	STARTED	Placebo	227
Overall Study	COMPLETED	AXS-07	441
Overall Study	COMPLETED	Meloxicam	433
Overall Study	COMPLETED	Rizatriptan	434
Overall Study	COMPLETED	Placebo	218
Overall Study	NOT COMPLETED	AXS-07	15
Overall Study	NOT COMPLETED	Meloxicam	22

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events20

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	Events
other	Nausea	Gastrointestinal disorders	AXS-07	12	441	12
other	Nausea	Gastrointestinal disorders	Meloxicam	14	433	15
other	Nausea	Gastrointestinal disorders	Rizatriptan	21	434	21
other	Nausea	Gastrointestinal disorders	Placebo	8	218	8
other	Dizziness	Nervous system disorders	AXS-07	7	441	7
other	Dizziness	Nervous system disorders	Meloxicam	5	433	5
other	Dizziness	Nervous system disorders	Rizatriptan	9	434	9
other	Dizziness	Nervous system disorders	Placebo	2	218	2
other	Somnolence	Nervous system disorders	AXS-07	6	441	6
other	Somnolence	Nervous system disorders	Meloxicam	10	433	10

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AXS-07	0	441
Total, all-cause mortality	Meloxicam	0	433
Total, all-cause mortality	Rizatriptan	0	434
Total, all-cause mortality	Placebo	0	218
Total, other adverse events	AXS-07	49	441
Total, other adverse events	Meloxicam	50	433
Total, other adverse events	Rizatriptan	67	434
Total, other adverse events	Placebo	13	218
Total, serious adverse events	AXS-07	1	441
Total, serious adverse events	Meloxicam	0	433

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

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 comparisons2

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

Comparison	Source
AXS-07 vs Placebo: Percentage of Subjects With Absence of Most Bothersome Symptom	Trial comparisons
AXS-07 vs Placebo: Percentage of Subjects Reporting Headache Pain Freedom	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/NCT03896009

GET https://conductscience.org/api/trials/v1/NCT03896009/registered

API reference For AI assistants