An Open-Label, Long-Term Study to Assess the Safety and Efficacy of AXS-07 (MoSEICâ„¢ 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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Study 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.Condition or Disease | Intervention/Treatment |
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Study Design
Study Type | Interventional |
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Actual Enrollment | 706 participants |
Design Allocation | N/A |
Interventional 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 (MoSEICâ„¢ Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults |
Study Start Date | July 6, 2019 |
Actual Primary Completion Date | September 22, 2020 |
Actual Study Completion Date | September 22, 2020 |
Groups and Cohorts
Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Ages Eligible for Study | 18 Years to 65 Years (Adult, Older Adult) |
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Sexes Eligible for Study | All |
Accepts Healthy Volunteers | No |
Inclusion Criteria |
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Exclusion Criteria |
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Contacts and Locations
Sponsors and Collaborators | Axsome Therapeutics, Inc. |
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Locations |
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Study Documents (Full Text)
- Documents Provided by Axsome Therapeutics, Inc.: Study Protocol and Statistical Analysis Plan October 17, 2019
More Information
Additional Relevant MeSH Terms
- Migraine Disorders
- Headache Disorders, Primary
- Headache Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases