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Open-Label Safety Study of AXS-05 in Subjects With Alzheimer's Disease Agitation

Primary Purpose

Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation, Psychomotor

Status
Enrolling by invitation
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AXS-05 (dextromethorphan-bupropion)
Sponsored by
Axsome Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Agitation in Patients With Dementia of the Alzheimer's Type focused on measuring AD agitation, AXS-05, NMDA receptor antagonist, dextromethorphan, bupropion, Axsome

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participation in Study AXS-05-AD-302 or Study AXS-05-AD-304.
  • Caregiver is willing to communicate with site personnel, comply with all required study procedures, and oversee administration and compliance with the subject's study treatment.

Exclusion Criteria:

  • Caregiver is unwilling or unable, in the opinion of the investigator, to comply with study instructions.
  • Subject is hospitalized in a mental health facility (e.g., psychiatric hospital or ward), living in a nursing home, or living alone.
  • Any concurrent medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or endanger the subject's well-being.
  • Initiation of a new medication since enrolling in AXS-05-AD-302 which may pose a safety risk when taken concurrently with AXS-05.

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AXS-05 (dextromethorphan-bupropion)

Arm Description

Up to 24 weeks

Outcomes

Primary Outcome Measures

Long-term Safety
Incidence of treatment-emergent adverse events following dosing with AXS-05.

Secondary Outcome Measures

Full Information

First Posted
June 24, 2021
Last Updated
March 3, 2023
Sponsor
Axsome Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04947553
Brief Title
Open-Label Safety Study of AXS-05 in Subjects With Alzheimer's Disease Agitation
Official Title
An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Dementia of the Alzheimer's Type
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 17, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

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
This is a multi-center, open-label trial to evaluate the long-term safety and efficacy of AXS-05 in subjects with agitation associated with Alzheimer's disease (AD).
Detailed Description
Eligible subjects may enroll into this open label study upon completing their final study visit of Study AXS-05-AD-302 or AXS-05-AD-304.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation, Psychomotor
Keywords
AD agitation, AXS-05, NMDA receptor antagonist, dextromethorphan, bupropion, Axsome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AXS-05 (dextromethorphan-bupropion)
Arm Type
Experimental
Arm Description
Up to 24 weeks
Intervention Type
Drug
Intervention Name(s)
AXS-05 (dextromethorphan-bupropion)
Intervention Description
AXS-05 tablets, taken twice daily
Primary Outcome Measure Information:
Title
Long-term Safety
Description
Incidence of treatment-emergent adverse events following dosing with AXS-05.
Time Frame
up to 24 weeks
Other Pre-specified Outcome Measures:
Title
Cohen-Mansfield Agitation Inventory (CMAI)
Description
Change from Baseline to Week 24 in the CMAI
Time Frame
up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participation in Study AXS-05-AD-302 or Study AXS-05-AD-304. Caregiver is willing to communicate with site personnel, comply with all required study procedures, and oversee administration and compliance with the subject's study treatment. Exclusion Criteria: Caregiver is unwilling or unable, in the opinion of the investigator, to comply with study instructions. Subject is hospitalized in a mental health facility (e.g., psychiatric hospital or ward), living in a nursing home, or living alone. Any concurrent medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or endanger the subject's well-being. Initiation of a new medication since enrolling in AXS-05-AD-302 which may pose a safety risk when taken concurrently with AXS-05.
Facility Information:
Facility Name
Clinical Research Site
City
Peoria
State/Province
Arizona
ZIP/Postal Code
83581
Country
United States
Facility Name
Clinical Research Site
City
Lafayette
State/Province
California
ZIP/Postal Code
94549
Country
United States
Facility Name
Clinical Research Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
Clinical Research Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Clinical Research Site
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Clinical Research Site
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Facility Name
Clinical Research Site
City
Greenacres City
State/Province
Florida
ZIP/Postal Code
33467
Country
United States
Facility Name
Clinical Research Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Clinical Research Site
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
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
Miami Gardens
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Clinical Research Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Clinical Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Clinical Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Clinical Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Clinical Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32807
Country
United States
Facility Name
Clinical Research Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
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
Trinity
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Clinical Research Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Clinical Research Site
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Clinical Research Site
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63005
Country
United States
Facility Name
Clinical Research Site
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Clinical Research Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Facility Name
Clinical Research Site
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Clinical Research Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Clinical Research Site
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Clinical Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78737
Country
United States
Facility Name
Clinical Research Site
City
Cypress
State/Province
Texas
ZIP/Postal Code
77429
Country
United States
Facility Name
Clinical Research Site
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Facility Name
Clinical Research Site
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Facility Name
Clinical Research Site
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1Z9
Country
Canada

12. IPD Sharing Statement

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

Learn more about this trial

Open-Label Safety Study of AXS-05 in Subjects With Alzheimer's Disease Agitation

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