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Open-Label Long-Term Safety Study of AXS-07 for the Acute Treatment of Migraine

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04068051
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

Study Description
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Brief Summary:
Study to evaluate the long-term safety of chronic intermittent use of AXS-07 and to assess the effect of AXS-07 on migraine symptoms following repeated treatment of migraine attacks.

Condition or disease Intervention/treatment Phase
Migraine Drug: AXS-07 Phase 3

Detailed Description:
This study is a Phase 3, multicenter, open-label, trial to evaluate the long-term safety and efficacy of intermittent chronic dosing with AXS-07 in subjects with migraine attacks. Eligible subjects will take AXS-07 following the onset of a migraine. Subjects will be treated for up to 12 months.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Long-Term Study to Assess the Safety and Efficacy of AXS-07 (MoSEIC Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults
Actual Study Start Date : July 6, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: AXS-07 Drug: AXS-07
AXS-07 (MoSEIC meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence and severity of adverse events [ Time Frame: Following dosing with AXS-07 over the course of up to one year ]
    Safety


Secondary Outcome Measures :
  1. Proportion of subjects with headache pain freedom [ Time Frame: Hour 2 following dose administration ]
    Absence of headache pain

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

  3. Proportion of subjects with headache pain relief [ Time Frame: Hour 2 following dose administration ]
    Mild or no headache pain

  4. Proportion 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


Eligibility Criteria
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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

Inclusion Criteria:

  • Has participated in a prior study with AXS-07 for the treatment of migraine

Exclusion Criteria:

  • Has previously received any investigational drug or device or investigational therapy within 30 days before Screening, other than AXS-07
  • Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
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): NCT04068051


Contacts
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Contact: Study Director 2123323241 ajones@axsome.com

Locations
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United States, Florida
Clinical Research Site Recruiting
Jacksonville, Florida, United States, 32256
Contact: Study Coordinator         
Sponsors and Collaborators
Axsome Therapeutics, Inc.
More Information
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Responsible Party: Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04068051    
Other Study ID Numbers: AXS-07-302
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: July 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.:
Axsome
AXS-07
MoSEIC 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