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Maximizing Outcomes in Treating Acute Migraine (MOMENTUM)

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: NCT03896009
Recruitment Status : Completed
First Posted : March 29, 2019
Last Update Posted : April 26, 2021
Sponsor:
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE March 15, 2019
First Posted Date  ICMJE March 29, 2019
Last Update Posted Date April 26, 2021
Actual Study Start Date  ICMJE March 4, 2019
Actual Primary Completion Date December 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
  • Percentage of subjects reporting headache pain freedom [ Time Frame: Hour 2 following dose administration ]
    Absence of headache pain
  • Percentage of subjects with absence of Most Bothersome Symptom [ Time Frame: Hour 2 following dose administration ]
    Absence of most bothersome symptom, defined at the onset of migraine
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
  • Percentage 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
  • Percentage of subjects reporting headache pain relief [ Time Frame: Hour 2 following dose administration ]
    Mild or no 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 Maximizing Outcomes in Treating Acute Migraine
Official Title  ICMJE MOMENTUM: 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
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 meloxicam, rizatriptan, and placebo for the treatment of a migraine attack.

This is a randomized, double-blind, 4-arm, parallel group, single-dose, placebo-controlled trial. Subjects who successfully complete screening and continue to meet all entry criteria will be randomly assigned to take one dose of either AXS-07, meloxicam, rizatriptan, or placebo upon the occurrence of a qualifying migraine.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE
  • Drug: AXS-07 (MoSEIC meloxicam and rizatriptan)
    AXS-07 taken once upon onset of a qualifying migraine.
  • Drug: Meloxicam
    Meloxicam taken once upon onset of a qualifying migraine.
  • Drug: Rizatriptan
    Rizatriptan taken once upon onset of a qualifying migraine.
  • Drug: Placebo
    Placebo taken once upon onset of a qualifying migraine.
Study Arms  ICMJE
  • Experimental: AXS-07
    Taken once upon a qualifying migraine
    Intervention: Drug: AXS-07 (MoSEIC meloxicam and rizatriptan)
  • Active Comparator: Meloxicam
    Taken once upon a qualifying migraine
    Intervention: Drug: Meloxicam
  • Active Comparator: Rizatriptan
    Taken once upon a qualifying migraine
    Intervention: Drug: Rizatriptan
  • Placebo Comparator: Placebo
    Taken once upon a qualifying migraine
    Intervention: Drug: Placebo
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 Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2020)
1594
Original Estimated Enrollment  ICMJE
 (submitted: March 28, 2019)
875
Actual Study Completion Date  ICMJE December 10, 2019
Actual Primary Completion Date December 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Has an established diagnosis of migraine with or without aura.
  • Has experienced an inadequate response to prior acute treatments.

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.
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03896009
Other Study ID Numbers  ICMJE AXS-07-301
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 April 2021

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