Open-Label Long-Term Safety Study of AXS-07 for the Acute Treatment of Migraine
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ClinicalTrials.gov Identifier: NCT04068051 |
Recruitment Status :
Completed
First Posted : August 28, 2019
Last Update Posted : September 16, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Migraine | Drug: AXS-07 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 706 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label, Long-Term Study to Assess the Safety and Efficacy of AXS-07 (MoSEIC Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults |
Actual Study Start Date : | July 6, 2019 |
Actual Primary Completion Date : | September 22, 2020 |
Actual Study Completion Date : | September 22, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: AXS-07 |
Drug: AXS-07
AXS-07 (MoSEIC meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine. |
- Incidence and severity of adverse events [ Time Frame: Following dosing with AXS-07 over the course of up to one year ]Safety
- Proportion of subjects with headache pain freedom [ Time Frame: Hour 2 following dose administration ]Absence of headache pain
- Proportion of subjects with absence of the most bothersome symptom [ Time Frame: Hour 2 following dose administration ]Absence of most bothersome symptom, defined at the onset of migraine
- Proportion of subjects with headache pain relief [ Time Frame: Hour 2 following dose administration ]Mild or no headache pain
- Proportion of subjects reporting sustained headache pain freedom [ Time Frame: Hours 2 through 24 following dose administration ]Sustained headache pain freedom without use of rescue medication and no relapse of headache pain

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068051

Responsible Party: | Axsome Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT04068051 |
Other Study ID Numbers: |
AXS-07-302 |
First Posted: | August 28, 2019 Key Record Dates |
Last Update Posted: | September 16, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Axsome AXS-07 MoSEIC meloxicam rizatriptan |
Migraine Disorders Headache Disorders, Primary Headache Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases |