A Randomized, Double-blind, Single-dose, Placebo-controlled Study to Assess the Efficacy and Safety of AXS-07 (Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults
ClinicalTrials.gov processed this data on April 28, 2021. Link to the current ClinicalTrials.gov record.Recruitment Status
COMPLETED (See Contacts and Locations)Verified April 2021 by Axsome Therapeutics, Inc.
Sponsor
Axsome Therapeutics, Inc.Information Provided by (Responsible Party)
Axsome Therapeutics, Inc.Clinicaltrials.gov Identifier
NCT04163185Other Study ID Numbers: AXS-07-303
First Submitted: November 12, 2019
First Posted: November 14, 2019
Last Update Posted: April 30, 2021
Last Verified: April 2021
History of Changes
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Study Description
Not ProvidedCondition or Disease | Intervention/Treatment |
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Study Design
Study Type | Interventional |
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Actual Enrollment | 302 participants |
Design Allocation | Randomized |
Interventional Model | Parallel Assignment |
Masking | Double |
Primary Purpose | Treatment |
Official Title | A Randomized, Double-blind, Single-dose, Placebo-controlled Study to Assess the Efficacy and Safety of AXS-07 (Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults |
Study Start Date | October 8, 2019 |
Actual Primary Completion Date | March 23, 2020 |
Actual Study Completion Date | March 23, 2020 |
Groups and Cohorts
Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- Percentage of subjects reporting headache pain freedom [Hour 2] Absence of headache pain
- Percentage of subjects with absence of Most Bothersome Symptom [Hour 2] Absence of Most Bothersome Symptom, defined at the onset of migraine
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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More Information
Additional Information
Additional Relevant MeSH Terms
- Migraine Disorders
- Headache Disorders, Primary
- Headache Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases