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Maximizing Outcomes in Treating Acute Migraine (MOMENTUM)

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ClinicalTrials.gov Identifier: NCT03896009
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 875 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
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: AXS-07
Taken once upon a qualifying migraine
Drug: AXS-07 (MoSEIC meloxicam and rizatriptan)
AXS-07 taken once upon onset of a qualifying migraine.

Active Comparator: Meloxicam
Taken once upon a qualifying migraine
Drug: Meloxicam
Meloxicam taken once upon onset of a qualifying migraine.

Active Comparator: Rizatriptan
Taken once upon a qualifying migraine
Drug: Rizatriptan
Rizatriptan taken once upon onset of a qualifying migraine.

Placebo Comparator: Placebo
Taken once upon a qualifying migraine
Drug: Placebo
Placebo taken once upon onset of a qualifying migraine.




Primary Outcome Measures :
  1. Percentage of subjects reporting headache pain freedom [ Time Frame: Hour 2 following dose administration ]
    Absence of headache pain

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Study Director +1 (212) 332-3241 MOMENTUM@axsome.com

Locations
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United States, Florida
MOMENTUM Study Site Recruiting
Miami, Florida, United States, 33132
Contact: Study Coordinator         
Sponsors and Collaborators
Axsome Therapeutics, Inc.

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Responsible Party: Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03896009     History of Changes
Other Study ID Numbers: AXS-07-301
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Axsome Therapeutics, Inc.:
Migraine
AXS-07
Meloxicam
Rizatriptan
Axsome
Axsome Therapeutics
MoSEIC meloxicam

Additional relevant MeSH terms:
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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