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
ClinicalTrials.gov processed this data on September 15, 2023. Link to the current ClinicalTrials.gov record.Recruitment Status
COMPLETED - HAS RESULTS(See Contacts and Locations)
Verified September 2023 by Axsome Therapeutics, Inc.
Sponsor
Axsome Therapeutics, Inc.Information Provided by (Responsible Party)
Axsome Therapeutics, Inc.Clinicaltrials.gov Identifier
NCT04068051Other Study ID Numbers: AXS-07-302
First Submitted: July 27, 2019
First Posted: August 28, 2019
Results First Posted: October 10, 2023
Last Update Posted: October 10, 2023
Last Verified: September 2023
History of Changes
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| Tracking Information | |
|---|---|
| First Submitted Date | July 27, 2019 |
| First Posted Date | August 28, 2019 |
| Results First Submitted Date | September 15, 2023 |
| Results First Posted Date | October 10, 2023 |
| Last Update Posted Date | October 10, 2023 |
| Study Start Date | July 6, 2019 |
| Actual Primary Completion Date | September 22, 2020 |
| Current Primary Outcome Measures(submitted: September 15, 2023) |
|
| Change History | Complete list of historical versions of study NCT04068051 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures | Not Provided |
| Current Other Outcome Measures | Not Provided |
| Descriptive Information | |
|---|---|
| Brief Title | Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT) |
| 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 |
| 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. |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: N/AInterventional Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Not Provided |
| Study Population | Not Provided |
| Condition |
|
| Intervention | Drug: AXS-07 AXS-07 (MoSEIC meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine. |
| Study Groups/Cohorts | Experimental: AXS-07 Intervention:
|
| Publications * | Not Provided |
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |
| Recruitment Information | |
|---|---|
| Recruitment Status | Completed |
| Actual Enrollment(submitted: September 15, 2023) | 706 |
| Actual Study Completion Date | September 22, 2020 |
| Actual Primary Study Completion Date | September 22, 2020 |
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
|
| Sex/Gender | Sexes Eligible for Study: All |
| Ages | 18 Years to 65 Years (Adult, Older Adult) |
| Accepts Healthy Volunteers | No |
| Contacts | Contact information is only displayed when the study is recruiting subjects |
| Listed Location Countries | United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States |
| Administrative Information | |
|---|---|
| NCT Number | NCT04068051 |
| Other Study ID Numbers | AXS-07-302 |
| Has Data Monitoring Committee | No |
| U.S FDA-regulated Product | Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: No Product Manufactured in and Exported from the U.S.: Not Provided |
| IPD Sharing Statement | Plan to Share IPD: No |
| Responsible Party | Axsome Therapeutics, Inc., Axsome Therapeutics, Inc. |
| Study Sponsor | Axsome Therapeutics, Inc. |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| PRS Account | Axsome Therapeutics, Inc. |
| Verification Date | September 2023 |