Trial Outcomes & Findings for Open-Label Safety Study of AXS-05 in Subjects With Depression (NCT NCT04039022)
NCT ID: NCT04039022
Last Updated: 2022-10-12
Results Overview
Types and rates of adverse events
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
876 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2022-10-12
Participant Flow
Participant milestones
| Measure |
AXS-05
AXS-05: Oral tablets, taken twice daily for up to 12 months.
|
|---|---|
|
Overall Study
STARTED
|
876
|
|
Overall Study
COMPLETED
|
53
|
|
Overall Study
NOT COMPLETED
|
823
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open-Label Safety Study of AXS-05 in Subjects With Depression
Baseline characteristics by cohort
| Measure |
AXS-05
n=876 Participants
AXS-05: Oral tablets, taken twice daily for up to 12 months.
|
|---|---|
|
Age, Continuous
|
42.5 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
560 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
316 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
301 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
509 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: Primary Safety Population (subjects who continued beyond Week 6 of the trial)
Types and rates of adverse events
Outcome measures
| Measure |
AXS-05
n=707 Participants
AXS-05: Oral tablets, taken twice daily for up to 12 months.
|
|---|---|
|
Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05
|
505 Participants
|
Adverse Events
AXS-05
Serious events: 21 serious events
Other events: 609 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
AXS-05
n=876 participants at risk
AXS-05: Oral tablets, taken twice daily for up to 12 months.
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.11%
1/876 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Cardiac disorders
Coronary artery disease
|
0.11%
1/876 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.11%
1/876 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Eye disorders
Eye inflammation
|
0.11%
1/876 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Gastrointestinal disorders
Nausea
|
0.11%
1/876 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
General disorders
Chest pain
|
0.11%
1/876 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
General disorders
Death
|
0.11%
1/876 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.11%
1/876 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Infections and infestations
Cellulitis
|
0.11%
1/876 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Infections and infestations
Diverticulitis
|
0.11%
1/876 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Injury, poisoning and procedural complications
Fall
|
0.11%
1/876 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.11%
1/876 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.11%
1/876 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.11%
1/876 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.11%
1/876 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Nervous system disorders
Seizure
|
0.11%
1/876 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Psychiatric disorders
Depression
|
0.11%
1/876 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Psychiatric disorders
Mental disorder
|
0.11%
1/876 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Psychiatric disorders
Suicidal ideation
|
0.11%
1/876 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.11%
1/876 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Vascular disorders
Aortic dissection
|
0.11%
1/876 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Vascular disorders
Peripheral artery occlusion
|
0.11%
1/876 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
Other adverse events
| Measure |
AXS-05
n=876 participants at risk
AXS-05: Oral tablets, taken twice daily for up to 12 months.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
3.3%
29/876 • Number of events 29 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Gastrointestinal disorders
Diarrhea
|
3.8%
33/876 • Number of events 37 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Nervous system disorders
Dizziness
|
12.7%
111/876 • Number of events 117 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Gastrointestinal disorders
Nausea
|
11.9%
104/876 • Number of events 110 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Nervous system disorders
Headache
|
8.8%
77/876 • Number of events 84 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Gastrointestinal disorders
Dry mouth
|
7.1%
62/876 • Number of events 64 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.1%
53/876 • Number of events 53 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Infections and infestations
Nasopharyngitis
|
4.5%
39/876 • Number of events 41 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Infections and infestations
Upper respiratory tract infection
|
4.0%
35/876 • Number of events 42 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Nervous system disorders
Somnolence
|
3.4%
30/876 • Number of events 33 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Psychiatric disorders
Anxiety
|
3.9%
34/876 • Number of events 36 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
|
Psychiatric disorders
Insomnia
|
3.5%
31/876 • Number of events 33 • Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
|
Additional Information
Caroline Streicher, Senior Director, Clinical Operations
Axsome Therapeutics, Inc.
Phone: 212-332-5061
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place