Maximizing Outcomes in Treating Acute Migraine (MOMENTUM)
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| ClinicalTrials.gov Identifier: NCT03896009 |
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Recruitment Status :
Completed
First Posted : March 29, 2019
Last Update Posted : April 26, 2021
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AXS-07 is an oral, investigational medicine consisting of MoSEIC meloxicam and rizatriptan, which is being developed for the acute treatment of migraine with or without aura in adults. AXS-07 tablets are formulated to provide an enhanced rate of absorption of meloxicam. This study is designed to evaluate the efficacy and safety of AXS-07 compared to meloxicam, rizatriptan, and placebo for the treatment of a migraine attack.
This is a randomized, double-blind, 4-arm, parallel group, single-dose, placebo-controlled trial. Subjects who successfully complete screening and continue to meet all entry criteria will be randomly assigned to take one dose of either AXS-07, meloxicam, rizatriptan, or placebo upon the occurrence of a qualifying migraine.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Migraine | Drug: AXS-07 (MoSEIC meloxicam and rizatriptan) Drug: Meloxicam Drug: Rizatriptan Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1594 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | MOMENTUM: 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 |
| Actual Study Start Date : | March 4, 2019 |
| Actual Primary Completion Date : | December 10, 2019 |
| Actual Study Completion Date : | December 10, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: AXS-07
Taken once upon a qualifying migraine
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Drug: AXS-07 (MoSEIC meloxicam and rizatriptan)
AXS-07 taken once upon onset of a qualifying migraine. |
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Active Comparator: Meloxicam
Taken once upon a qualifying migraine
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Drug: Meloxicam
Meloxicam taken once upon onset of a qualifying migraine. |
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Active Comparator: Rizatriptan
Taken once upon a qualifying migraine
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Drug: Rizatriptan
Rizatriptan taken once upon onset of a qualifying migraine. |
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Placebo Comparator: Placebo
Taken once upon a qualifying migraine
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Drug: Placebo
Placebo taken once upon onset of a qualifying migraine. |
- Percentage of subjects reporting headache pain freedom [ Time Frame: Hour 2 following dose administration ]Absence of headache pain
- Percentage of subjects with absence of Most Bothersome Symptom [ Time Frame: Hour 2 following dose administration ]Absence of most bothersome symptom, defined at the onset of migraine
- Percentage 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
- Percentage of subjects reporting headache pain relief [ Time Frame: Hour 2 following dose administration ]Mild or no 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 |
Key Inclusion Criteria:
- Has an established diagnosis of migraine with or without aura.
- Has experienced an inadequate response to prior acute treatments.
Key Exclusion Criteria:
- Has previously received any investigational drug or device or investigational therapy within 30 days before Screening.
- 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): NCT03896009
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| Responsible Party: | Axsome Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT03896009 |
| Other Study ID Numbers: |
AXS-07-301 |
| First Posted: | March 29, 2019 Key Record Dates |
| Last Update Posted: | April 26, 2021 |
| Last Verified: | April 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Migraine AXS-07 Meloxicam Rizatriptan |
Axsome Axsome Therapeutics MoSEIC meloxicam |
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Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Meloxicam Rizatriptan Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents |