Trial record 1 of 1 for:
AXS-07 + intercept
Initiating Early Control of Migraine Pain and Associated Symptoms (INTERCEPT)
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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 |
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Recruitment Status :
Completed
First Posted : November 14, 2019
Last Update Posted : April 30, 2021
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Sponsor:
Axsome Therapeutics, Inc.
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.
- Study Details
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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 |
| 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 |
|---|---|
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Experimental: AXS-07
Taken once upon migraine
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Drug: AXS-07 (MoSEIC meloxicam and rizatriptan)
AXS-07 tablet taken once upon the earliest onset of migraine pain. |
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Placebo Comparator: Placebo
Taken once upon migraine
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Drug: Placebo
Placebo tablet taken once upon the earliest onset of migraine pain. |
Primary Outcome Measures :
- Percentage of subjects reporting headache pain freedom [ Time Frame: Hour 2 ]Absence of headache pain
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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
| 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:
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Axsome Therapeutics, Inc.:
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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 |