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Initiating Early Control of Migraine Pain and Associated Symptoms (INTERCEPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04163185
Recruitment Status : Completed
First Posted : November 14, 2019
Last Update Posted : April 30, 2021
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 placebo.

This is a randomized, double-blind, single-dose, placebo-controlled trial. Subjects who successfully complete the screening period and continue to meet all entry criteria will be randomly assigned to take one dose of either AXS-07 or placebo upon the earliest onset of migraine pain.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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
Actual Study Start Date : October 8, 2019
Actual Primary Completion Date : March 23, 2020
Actual Study Completion Date : March 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

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

Placebo Comparator: Placebo
Taken once upon migraine
Drug: Placebo
Placebo tablet taken once upon the earliest onset of migraine pain.




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

  2. Percentage of subjects with absence of Most Bothersome Symptom [ Time Frame: Hour 2 ]
    Absence of Most Bothersome Symptom, defined at the onset of migraine



Information from the National Library of Medicine

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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.

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): NCT04163185


Locations
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United States, Alabama
Clinical Research Site
Birmingham, Alabama, United States, 35205
Clinical Research Site
Birmingham, Alabama, United States, 35216
Clinical Research Site
Mobile, Alabama, United States, 36608
United States, California
Clinical Research Site
Colton, California, United States, 92399
Clinical Research Site
Encino, California, United States, 91316
Clinical Research Site
Los Alamitos, California, United States, 90720
Clinical Research Site
Los Angeles, California, United States, 90017
Clinical Research Site
Redlands, California, United States, 92374
Clinical Research Site
Santa Monica, California, United States, 90404
Clinical Research Site
Spring Valley, California, United States, 91978
Clinical Research Site
Walnut Creek, California, United States, 94598
United States, Florida
Clinical Research Site
Hallandale Beach, Florida, United States, 33009
Clinical Research Site
Jacksonville, Florida, United States, 32256
Clinical Research Site
Lake City, Florida, United States, 32055
Clinical Research Site
Lake Worth, Florida, United States, 33467
Clinical Research Site
Ocoee, Florida, United States, 34761
Clinical Research Site
Orlando, Florida, United States, 32801
Clinical Research Site
Ormond Beach, Florida, United States, 32174
Clinical Research Site
South Miami, Florida, United States, 33143
Clinical Research Site
Sunrise, Florida, United States, 33351
Clinical Research Site
Tampa, Florida, United States, 33634
United States, Georgia
Clinical Research Site
Stockbridge, Georgia, United States, 30281
United States, Illinois
Clinical Research Site
Evanston, Illinois, United States, 60201
United States, Kentucky
Clinical Research Site
Louisville, Kentucky, United States, 40213
United States, Massachusetts
Clinical Research Site
Boston, Massachusetts, United States, 02131
Clinical Research Site
Waltham, Massachusetts, United States, 02451
United States, Michigan
Clinical Research Site
Ann Arbor, Michigan, United States, 48104
United States, Missouri
Clinical Research Site
Springfield, Missouri, United States, 65810
United States, New Mexico
Clinical Research Site
Albuquerque, New Mexico, United States, 87102
United States, New York
Clinical Research Site
Manlius, New York, United States, 13104
Clinical Research Site
Williamsville, New York, United States, 14221
United States, North Carolina
Clinical Research Site
High Point, North Carolina, United States, 27262
United States, Oklahoma
Clinical Research Site
Oklahoma City, Oklahoma, United States, 73106
United States, Pennsylvania
Clinical Research Site
Philadelphia, Pennsylvania, United States, 19114
United States, South Carolina
Clinical Research Site
Charleston, South Carolina, United States, 29406
Clinical Research Site
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Clinical Research Site
Memphis, Tennessee, United States, 38119
Clinical Research Site
Nashville, Tennessee, United States, 37203
United States, Texas
Clinical Research Site
Austin, Texas, United States, 78731
United States, Utah
Clinical Research Site
Salt Lake City, Utah, United States, 84107
United States, Virginia
Clinical Research Site
Charlottesville, Virginia, United States, 22911
Sponsors and Collaborators
Axsome Therapeutics, Inc.
Additional Information:
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Responsible Party: Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04163185    
Other Study ID Numbers: AXS-07-303
First Posted: November 14, 2019    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021
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
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