Trial Outcomes & Findings for An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study (NCT NCT06736509)
NCT ID: NCT06736509
Last Updated: 2026-06-25
Results Overview
Incidence of treatment-emergent adverse events following dosing with AXS-05
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
139 participants
Primary outcome timeframe
Up to 25 weeks
Results posted on
2026-06-25
Participant Flow
Participant milestones
| Measure |
Open-Label
Experimental: AXS-05 (dextromethorphan-bupropion) up to 25 weeks
AXS-05 (dextromethorphan-bupropion): AXS-05 tablets, taken twice daily
|
|---|---|
|
Overall Study
STARTED
|
139
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
139
|
Reasons for withdrawal
| Measure |
Open-Label
Experimental: AXS-05 (dextromethorphan-bupropion) up to 25 weeks
AXS-05 (dextromethorphan-bupropion): AXS-05 tablets, taken twice daily
|
|---|---|
|
Overall Study
Study Terminated by Sponsor
|
137
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Other
|
1
|
Baseline Characteristics
An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study
Baseline characteristics by cohort
| Measure |
Open-Label
n=139 Participants
Experimental: AXS-05 (dextromethorphan-bupropion) up to 25 weeks
AXS-05 (dextromethorphan-bupropion): AXS-05 tablets, taken twice daily
|
|---|---|
|
Age, Continuous
|
74.3 years
STANDARD_DEVIATION 5.31 • n=20 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
14 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
White
|
124 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Up to 25 weeksIncidence of treatment-emergent adverse events following dosing with AXS-05
Outcome measures
| Measure |
Open-Label
n=139 Participants
Experimental: AXS-05 (dextromethorphan-bupropion) up to 25 weeks
AXS-05 (dextromethorphan-bupropion): AXS-05 tablets, taken twice daily
|
|---|---|
|
Long-Term Safety
Subjects with TEAEs that resulted in death
|
0 Participants
|
|
Long-Term Safety
Subjects with no TEAEs
|
116 Participants
|
|
Long-Term Safety
Subjects with any TEAEs
|
16 Participants
|
|
Long-Term Safety
Subjects with TEAEs that led to study discontinuation
|
0 Participants
|
|
Long-Term Safety
Subjects with suspected to be drug-related TEAEs
|
7 Participants
|
|
Long-Term Safety
Subjects with serious TEAEs
|
0 Participants
|
|
Long-Term Safety
Subjects with TEAEs that led to drug withdrawal
|
0 Participants
|
Adverse Events
Open-Label
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Open-Label
n=139 participants at risk
Experimental: AXS-05 (dextromethorphan-bupropion) up to 25 weeks
AXS-05 (dextromethorphan-bupropion): AXS-05 tablets, taken twice daily
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
3/139 • Number of events 7 • Treatment emergent adverse events (TEAEs) were collected after administration of study drug through 7 days after the last dose (up to 25 weeks).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.9%
4/139 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected after administration of study drug through 7 days after the last dose (up to 25 weeks).
|
|
Nervous system disorders
Headache
|
2.9%
4/139 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected after administration of study drug through 7 days after the last dose (up to 25 weeks).
|
|
Infections and infestations
Influenza
|
1.4%
2/139 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected after administration of study drug through 7 days after the last dose (up to 25 weeks).
|
|
Nervous system disorders
Somnolence
|
1.4%
2/139 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected after administration of study drug through 7 days after the last dose (up to 25 weeks).
|
|
Nervous system disorders
Tremor
|
1.4%
2/139 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected after administration of study drug through 7 days after the last dose (up to 25 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place