Trial Outcomes & Findings for Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT) (NCT NCT04068051)

Last Updated: 2023-10-10

Results Overview

Long-term safety as measured by: Subjects with any TEAEs Subjects with suspected to be drug-related TEAEs Subjects with serious TEAEs Subjects with TEAEs that led to drug withdrawal Subjects with TEAEs that led to withdrawal from study Subjects with TEAEs that resulted in death

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

706 participants

Primary outcome timeframe

Up to 12 months

Results posted on

2023-10-10

Participant Flow

Participant milestones

Participant milestones
Measure	AXS-07 AXS-07 (MoSEIC™ meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine.
Overall Study STARTED	706
Overall Study COMPLETED	138
Overall Study NOT COMPLETED	568

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AXS-07 n=706 Participants AXS-07 (MoSEIC™ meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine.
Age, Continuous	42.0 years STANDARD_DEVIATION 10.94 • n=99 Participants
Sex: Female, Male Female	580 Participants n=99 Participants
Sex: Female, Male Male	126 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	7 Participants n=99 Participants
Race (NIH/OMB) Asian	12 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	132 Participants n=99 Participants
Race (NIH/OMB) White	544 Participants n=99 Participants
Race (NIH/OMB) More than one race	9 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants

PRIMARY outcome

Timeframe: Up to 12 months

Population: Safety Population includes all subjects who received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	AXS-07 n=706 Participants AXS-07 (MoSEIC™ meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine.
Long-term Safety of Chronic Intermittent Use of AXS-07 Subjects with any TEAEs	293 Participants
Long-term Safety of Chronic Intermittent Use of AXS-07 Subjects with suspected to be drug-related TEAEs	118 Participants
Long-term Safety of Chronic Intermittent Use of AXS-07 Subjects with serious TEAEs	8 Participants
Long-term Safety of Chronic Intermittent Use of AXS-07 Subjects with TEAEs that led to drug withdrawal	10 Participants
Long-term Safety of Chronic Intermittent Use of AXS-07 Subjects with TEAEs that led to withdrawal from study	13 Participants
Long-term Safety of Chronic Intermittent Use of AXS-07 Subjects with TEAEs that resulted in death	0 Participants

Adverse Events

AXS-07

Serious events: 8 serious events

Other events: 95 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AXS-07 n=706 participants at risk AXS-07 (MoSEIC™ meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine.
Cardiac disorders Mitral valve incompetence	0.14% 1/706 • Number of events 1 • Adverse events were collected after administration of study drug through the final visit (up to 12 months). Any AE was monitored up to a maximum of 30 days after the final visit. Safety Population includes all subjects who received at least one dose of study drug.
Gastrointestinal disorders Hiatus hernia	0.14% 1/706 • Number of events 1 • Adverse events were collected after administration of study drug through the final visit (up to 12 months). Any AE was monitored up to a maximum of 30 days after the final visit. Safety Population includes all subjects who received at least one dose of study drug.
Hepatobiliary disorders Hepatitis acute	0.14% 1/706 • Number of events 1 • Adverse events were collected after administration of study drug through the final visit (up to 12 months). Any AE was monitored up to a maximum of 30 days after the final visit. Safety Population includes all subjects who received at least one dose of study drug.
Injury, poisoning and procedural complications Burns third degree	0.14% 1/706 • Number of events 1 • Adverse events were collected after administration of study drug through the final visit (up to 12 months). Any AE was monitored up to a maximum of 30 days after the final visit. Safety Population includes all subjects who received at least one dose of study drug.
Injury, poisoning and procedural complications Musculoskeletal procedural complication	0.14% 1/706 • Number of events 1 • Adverse events were collected after administration of study drug through the final visit (up to 12 months). Any AE was monitored up to a maximum of 30 days after the final visit. Safety Population includes all subjects who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.14% 1/706 • Number of events 1 • Adverse events were collected after administration of study drug through the final visit (up to 12 months). Any AE was monitored up to a maximum of 30 days after the final visit. Safety Population includes all subjects who received at least one dose of study drug.
Reproductive system and breast disorders Endometrial hyperplasia	0.14% 1/706 • Number of events 1 • Adverse events were collected after administration of study drug through the final visit (up to 12 months). Any AE was monitored up to a maximum of 30 days after the final visit. Safety Population includes all subjects who received at least one dose of study drug.
Social circumstances Victim of crime	0.14% 1/706 • Number of events 1 • Adverse events were collected after administration of study drug through the final visit (up to 12 months). Any AE was monitored up to a maximum of 30 days after the final visit. Safety Population includes all subjects who received at least one dose of study drug.
Surgical and medical procedures Skin graft	0.14% 1/706 • Number of events 1 • Adverse events were collected after administration of study drug through the final visit (up to 12 months). Any AE was monitored up to a maximum of 30 days after the final visit. Safety Population includes all subjects who received at least one dose of study drug.

Other adverse events

Other adverse events
Measure	AXS-07 n=706 participants at risk AXS-07 (MoSEIC™ meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine.
Gastrointestinal disorders Nausea	5.7% 40/706 • Number of events 88 • Adverse events were collected after administration of study drug through the final visit (up to 12 months). Any AE was monitored up to a maximum of 30 days after the final visit. Safety Population includes all subjects who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	4.7% 33/706 • Number of events 48 • Adverse events were collected after administration of study drug through the final visit (up to 12 months). Any AE was monitored up to a maximum of 30 days after the final visit. Safety Population includes all subjects who received at least one dose of study drug.
Nervous system disorders Dizziness	3.1% 22/706 • Number of events 45 • Adverse events were collected after administration of study drug through the final visit (up to 12 months). Any AE was monitored up to a maximum of 30 days after the final visit. Safety Population includes all subjects who received at least one dose of study drug.

Additional Information

Caroline Streicher, Vice President, 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