An Open-Label, Multiple-Dose Evaluation of the Efficacy and Safety of AXS-07 (Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor
ClinicalTrials.gov processed this data on April 25, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
RECRUITING (See Contacts and Locations)Verified April 2024 by Axsome Therapeutics, Inc.
Sponsor
Axsome Therapeutics, Inc.Information Provided by (Responsible Party)
Axsome Therapeutics, Inc.Clinicaltrials.gov Identifier
NCT05550207Other Study ID Numbers: AXS-07-304
First Submitted: September 19, 2022
First Posted: September 22, 2022
Last Update Posted: April 26, 2024
Last Verified: April 2024
History of Changes
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Study Description
Eligible subjects will receive open-label AXS-07 for up to 8 weeks for at-home treatment of their next 4 migraine attacks.Condition or Disease | Intervention/Treatment |
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Study Design
Study Type | Interventional |
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Anticipated Enrollment | 100 participants |
Design Allocation | N/A |
Interventional Model | Single Group Assignment |
Masking | None (Open Label) |
Primary Purpose | Treatment |
Official Title | An Open-Label, Multiple-Dose Evaluation of the Efficacy and Safety of AXS-07 (Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor |
Study Start Date | August 31, 2022 |
Anticipated Primary Completion Date | December 2024 |
Anticipated Study Completion Date | December 2024 |
Groups and Cohorts
Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- Percentage of subjects with headache pain relief [Hour 2 following dose administration] Absence of headache pain and without the use of rescue medication.
- Percentage of subjects with absence of the Most Bothersome Symptom [Hour 2 following dose administration] Absence of the most bothersome symptom, defined at the onset of migraine.
Eligibility Criteria
Ages Eligible for Study | 18 Years and Older (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