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

Primary Purpose

Migraine

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AXS-07 (MoSEIC meloxicam and rizatriptan)
Placebo
Sponsored by
Axsome Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine, AXS-07, Meloxicam, Rizatriptan

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical Research Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AXS-07

Placebo

Arm Description

Taken once upon migraine

Taken once upon migraine

Outcomes

Primary Outcome Measures

Percentage of subjects reporting headache pain freedom
Absence of headache pain
Percentage of subjects with absence of Most Bothersome Symptom
Absence of Most Bothersome Symptom, defined at the onset of migraine

Secondary Outcome Measures

Full Information

First Posted
November 12, 2019
Last Updated
April 28, 2021
Sponsor
Axsome Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04163185
Brief Title
Initiating Early Control of Migraine Pain and Associated Symptoms
Acronym
INTERCEPT
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 8, 2019 (Actual)
Primary Completion Date
March 23, 2020 (Actual)
Study Completion Date
March 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Axsome Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, AXS-07, Meloxicam, Rizatriptan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
302 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AXS-07
Arm Type
Experimental
Arm Description
Taken once upon migraine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Taken once upon migraine
Intervention Type
Drug
Intervention Name(s)
AXS-07 (MoSEIC meloxicam and rizatriptan)
Intervention Description
AXS-07 tablet taken once upon the earliest onset of migraine pain.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet taken once upon the earliest onset of migraine pain.
Primary Outcome Measure Information:
Title
Percentage of subjects reporting headache pain freedom
Description
Absence of headache pain
Time Frame
Hour 2
Title
Percentage of subjects with absence of Most Bothersome Symptom
Description
Absence of Most Bothersome Symptom, defined at the onset of migraine
Time Frame
Hour 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Clinical Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Clinical Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Clinical Research Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Clinical Research Site
City
Colton
State/Province
California
ZIP/Postal Code
92399
Country
United States
Facility Name
Clinical Research Site
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Clinical Research Site
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Clinical Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Clinical Research Site
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Clinical Research Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Clinical Research Site
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Clinical Research Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Clinical Research Site
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Clinical Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Clinical Research Site
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Facility Name
Clinical Research Site
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33467
Country
United States
Facility Name
Clinical Research Site
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Clinical Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Clinical Research Site
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Clinical Research Site
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Clinical Research Site
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Clinical Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
Clinical Research Site
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Clinical Research Site
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Clinical Research Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Clinical Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Clinical Research Site
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Facility Name
Clinical Research Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Clinical Research Site
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65810
Country
United States
Facility Name
Clinical Research Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Clinical Research Site
City
Manlius
State/Province
New York
ZIP/Postal Code
13104
Country
United States
Facility Name
Clinical Research Site
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Clinical Research Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Clinical Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Facility Name
Clinical Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Clinical Research Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Clinical Research Site
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Clinical Research Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Clinical Research Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Clinical Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Clinical Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Clinical Research Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://axsome.com
Description
Axsome Website

Learn more about this trial

Initiating Early Control of Migraine Pain and Associated Symptoms

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