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Open-Label Study of AXS-07 for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor (EMERGE)

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ClinicalTrials.gov Identifier: NCT05550207
Recruitment Status : Recruiting
First Posted : September 22, 2022
Last Update Posted : April 26, 2024
Sponsor:
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

Study Description
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Brief Summary:
This is a multicenter, open-label trial to evaluate the efficacy and safety of AXS-07 in subjects with migraine attacks and prior inadequate response to oral CGRP inhibitors.

Condition or disease Intervention/treatment Phase
Migraine Drug: AXS-07 (meloxicam-rizatriptan) Phase 3

Detailed Description:
Eligible subjects will receive open-label AXS-07 for up to 8 weeks for at-home treatment of their next 4 migraine attacks.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention 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
Actual Study Start Date : August 31, 2022
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: AXS-07 (meloxicam-rizatriptan)
Up to 8 weeks
 Drug: AXS-07 (meloxicam-rizatriptan)
AXS-07 tablets, taken orally for the acute treatment of migraine


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of subjects with headache pain relief [ Time Frame: Hour 2 following dose administration ]
    Absence of headache pain and without the use of rescue medication.

  2. Percentage of subjects with absence of the Most Bothersome Symptom [ Time Frame: Hour 2 following dose administration ]
    Absence of the most bothersome symptom, defined at the onset of migraine.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has an established diagnosis of migraine with or without aura
  • Has experienced an inadequate response to oral CGRP inhibitors for the acute treatment of migraine

Exclusion Criteria:

  • Pregnant, breastfeeding, or planning to become pregnant during the study
  • Has previously received any investigational drug or device or investigational therapy within 30 days before Screening
Contacts and Locations
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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): NCT05550207


Contacts
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Contact: Study Director +1 (212) 332-5061 cstreicher@axsome.com

Locations
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United States, California
Clinical Research Site Recruiting
Colton, California, United States, 92324
Clinical Research Site Recruiting
Fullerton, California, United States, 92835
Clinical Research Site Recruiting
La Jolla, California, United States, 92037
Clinical Research Site Recruiting
Los Angeles, California, United States, 90067
Clinical Research Site Recruiting
Sherman Oaks, California, United States, 91403
United States, Connecticut
Clinical Research Site Recruiting
Stamford, Connecticut, United States, 06905
United States, Florida
Clinical Research Site Recruiting
Coral Gables, Florida, United States, 33134
Clinical Research Site Recruiting
DeLand, Florida, United States, 32720
Clinical Research Site Recruiting
Hallandale Beach, Florida, United States, 33009
Clinical Research Site Recruiting
Ormond Beach, Florida, United States, 31274
Clinical Research Site Recruiting
Oviedo, Florida, United States, 32765
Clinical Research Site Recruiting
Pensacola, Florida, United States, 32504
Clinical Research Site Recruiting
Sunrise, Florida, United States, 33351
Clinical Research Site Recruiting
Winter Park, Florida, United States, 32789
United States, Georgia
Clinical Research Site Recruiting
Stockbridge, Georgia, United States, 30281
United States, Indiana
Clinical Research Site Recruiting
Avon, Indiana, United States, 46123
United States, Massachusetts
Clinical Research Site Recruiting
Boston, Massachusetts, United States, 02131
Clinical Research Site Active, not recruiting
North Dartmouth, Massachusetts, United States, 02747
United States, Nevada
Clinical Research Site Recruiting
Las Vegas, Nevada, United States, 89102
United States, New Mexico
Clinical Research Site Recruiting
Albuquerque, New Mexico, United States, 87102
United States, New York
Clinical Research Site Recruiting
Bronx, New York, United States, 10466
Clinical Research Site Recruiting
Williamsville, New York, United States, 14221
United States, North Carolina
Clinical Research Site Recruiting
High Point, North Carolina, United States, 27262
United States, Pennsylvania
Clinical Research Site Recruiting
Philadelphia, Pennsylvania, United States, 19114
United States, South Carolina
Clinical Research Site Recruiting
Charleston, South Carolina, United States, 29406
United States, Tennessee
Clinical Research Site Recruiting
Knoxville, Tennessee, United States, 37909
Clinical Research Site Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Clinical Research Site Recruiting
Cypress, Texas, United States, 77429
Clinical Research Site Recruiting
Sugar Land, Texas, United States, 77478
United States, Utah
Clinical Research Site Recruiting
Salt Lake City, Utah, United States, 84107
United States, Virginia
Clinical Research Site Recruiting
Charlottesville, Virginia, United States, 22911
Clinical Research Site Recruiting
McLean, Virginia, United States, 22101
Sponsors and Collaborators
Axsome Therapeutics, Inc.
More Information
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Additional Information:

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Responsible Party: Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05550207    
Other Study ID Numbers: AXS-07-304
First Posted: September 22, 2022    Key Record Dates
Last Update Posted: April 26, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Oral CGRP inhibitor
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