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Trial record 3 of 12 for:    Axsome

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.

Tracking Information
First Submitted Date  ICMJE July 27, 2019
First Posted Date  ICMJE August 28, 2019
Last Update Posted Date August 28, 2019
Actual Study Start Date  ICMJE July 6, 2019
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2019)
Incidence and severity of adverse events [ Time Frame: Following dosing with AXS-07 over the course of up to one year ]
Safety
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2019)
  • Proportion of subjects with headache pain freedom [ Time Frame: Hour 2 following dose administration ]
    Absence of headache pain
  • 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
  • Proportion of subjects with headache pain relief [ Time Frame: Hour 2 following dose administration ]
    Mild or no headache pain
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-Label Long-Term Safety Study of AXS-07 for the Acute Treatment of Migraine
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE Drug: AXS-07
AXS-07 (MoSEIC meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine.
Study Arms  ICMJE Experimental: AXS-07
Intervention: Drug: AXS-07
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 22, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Director 2123323241 ajones@axsome.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04068051
Other Study ID Numbers  ICMJE AXS-07-302
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Axsome Therapeutics, Inc.
Study Sponsor  ICMJE Axsome Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Axsome Therapeutics, Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP