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

• Sponsor: Axsome Therapeutics, Inc. (Industry)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04947553
• Collaborator: (none)
• Enrollment: 260
• Locations: 19
• Arm: 1
• Anticipated Duration (Months): 23.5
• Patients Per Site: 13.7
• Patients Per Site Per Month: 0.6

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Agitation in Patients With Dementia of the Alzheimer's Type; Alzheimer Disease; Agitation, Psychomotor	Drug: AXS-05 (dextromethorphan-bupropion)	Phase 3

Detailed Description

Eligible subjects may enroll into this open label study upon their final study visit of Study AXS-05-AD-302, either following study completion or at the time of relapse of agitation symptoms.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 260 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 17, 2021
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AXS-05 (dextromethorphan-bupropion) Up to 24 weeks	Drug: AXS-05 (dextromethorphan-bupropion); AXS-05 tablets, taken twice daily

Outcome Measures

Primary Outcome Measures

1. Long-term Safety [up to 24 weeks]

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

Other Outcome Measures

1. Cohen-Mansfield Agitation Inventory (CMAI) [up to 24 weeks]

   Change from Baseline to Week 24 in the CMAI

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participation in Study AXS-05-AD-302.

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Site	Lafayette	California	United States	94549
2	Clinical Research Site	Santa Ana	California	United States	92705
3	Clinical Research Site	Coral Springs	Florida	United States	33067
4	Clinical Research Site	Hialeah	Florida	United States	33012
5	Clinical Research Site	Kissimmee	Florida	United States	34741
6	Clinical Research Site	Lake City	Florida	United States	32055
7	Clinical Research Site	Miami	Florida	United States	33155
8	Clinical Research Site	Miami	Florida	United States	33175
9	Clinical Research Site	Orlando	Florida	United States	32807
10	Clinical Research Site	Sunrise	Florida	United States	33351
11	Clinical Research Site	Trinity	Florida	United States	34655
12	Clinical Research Site	Toms River	New Jersey	United States	08755
13	Clinical Research Site	Brooklyn	New York	United States	11229
14	Clinical Research Site	New Windsor	New York	United States	12553
15	Clinical Research Site	Hickory	North Carolina	United States	28601
16	Clinical Research Site	Austin	Texas	United States	78737
17	Clinical Research Site	Cypress	Texas	United States	77429
18	Clinical Research Site	McKinney	Texas	United States	75071
19	Clinical Research Site	Mesquite	Texas	United States	75149

Sponsors and Collaborators

• Axsome Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Axsome Therapeutics Website

Publications

None provided.

• Responsible Party: Axsome Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT04947553
• Other Study ID Numbers: AXS-05-AD-303
• First Posted: Jul 1, 2021
• Last Update Posted: May 12, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Axsome Therapeutics, Inc.: AD agitation; AXS-05; NMDA receptor antagonist; dextromethorphan; bupropion; Axsome
• Additional relevant MeSH terms: Alzheimer Disease; Dementia; Psychomotor Agitation; Dextromethorphan; Bupropion

Study Results

No Results Posted as of May 12, 2022