Migraine
Conditions
Keywords
Axsome, AXS-07, MoSEIC™ meloxicam, rizatriptan
Brief summary
MOVEMENT (Multimechanistic Treatment over Time of Migraine Symptoms) is a Phase 3 study to evaluate the long-term safety of chronic intermittent use of AXS-07 and to assess the effect of AXS-07 on migraine symptoms following repeated treatment of migraine attacks.
Detailed description
This study is a Phase 3, multicenter, open-label, trial to evaluate the long-term safety and efficacy of intermittent chronic dosing with AXS-07 in subjects with migraine attacks. Eligible subjects will take AXS-07 following the onset of a migraine. Subjects will be treated for up to 12 months.
Interventions
DRUGAXS-07
AXS-07 (MoSEIC meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine.
Sponsors
Axsome Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Has participated in a prior study with AXS-07 for the treatment of migraine
Exclusion criteria
* Has previously received any investigational drug or device or investigational therapy within 30 days before Screening, other than AXS-07 * Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-term Safety of Chronic Intermittent Use of AXS-07 | Up to 12 months | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AXS-07 AXS-07 (MoSEIC™ meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine. | 706 |
| Total | 706 |
Baseline characteristics
| Characteristic | AXS-07 |
|---|---|
| Age, Continuous | 42.0 years STANDARD_DEVIATION 10.94 |
| Race (NIH/OMB) American Indian or Alaska Native | 7 Participants |
| Race (NIH/OMB) Asian | 12 Participants |
| Race (NIH/OMB) Black or African American | 132 Participants |
| Race (NIH/OMB) More than one race | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 544 Participants |
| Sex: Female, Male Female | 580 Participants |
| Sex: Female, Male Male | 126 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 706 |
| other Total, other adverse events | 95 / 706 |
| serious Total, serious adverse events | 8 / 706 |
Outcome results
Primary
Long-term Safety of Chronic Intermittent Use of AXS-07
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
Time frame: Up to 12 months
Population: Safety Population includes all subjects who received at least one dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AXS-07 | Long-term Safety of Chronic Intermittent Use of AXS-07 | Subjects with any TEAEs | 293 Participants |
| AXS-07 | Long-term Safety of Chronic Intermittent Use of AXS-07 | Subjects with suspected to be drug-related TEAEs | 118 Participants |
| AXS-07 | Long-term Safety of Chronic Intermittent Use of AXS-07 | Subjects with serious TEAEs | 8 Participants |
| AXS-07 | Long-term Safety of Chronic Intermittent Use of AXS-07 | Subjects with TEAEs that led to drug withdrawal | 10 Participants |
| AXS-07 | Long-term Safety of Chronic Intermittent Use of AXS-07 | Subjects with TEAEs that led to withdrawal from study | 13 Participants |
| AXS-07 | Long-term Safety of Chronic Intermittent Use of AXS-07 | Subjects with TEAEs that resulted in death | 0 Participants |