Trial Outcomes & Findings for SXC-2023 Cocaine Interaction Study (NCT NCT06343532)
NCT ID: NCT06343532
Last Updated: 2026-04-24
Results Overview
Assessing the number of treatment emergent adverse events using the most recent version of the Medical Dictionary of Regulatory Activities (MedDRA) preferred terms. Adverse events were either reported by the participants or determined by clinically significant abnormal findings on: i. Physical examination ii. Measurement of vital signs (heart rate, blood pressure) iii. Clinical laboratory findings
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
19 participants
Primary outcome timeframe
Study Days -2,1,2,8,9,11
Results posted on
2026-04-24
Participant Flow
Participants were recruited in the Kansas City Area. The first participant was enrolled on 10/08, 2024, and the last participant's End of Study (EOS) date was 12/30/2024
76 participants were screened, and 19 were randomized to SXC-2023 (n=10) or placebo (n=9) treatment. 9 participants completed active treatment and 8 participants completed placebo treatment.
Participant milestones
| Measure |
SXC-2023
SXC-2023: 800mg once a day for 7 days
|
SXC-2023 Placebo
Placebo: 800mg once a day for 7 days
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
|
Overall Study
COMPLETED
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
SXC-2023
SXC-2023: 800mg once a day for 7 days
|
SXC-2023 Placebo
Placebo: 800mg once a day for 7 days
|
|---|---|---|
|
Overall Study
family emergency
|
0
|
1
|
|
Overall Study
failed to meet blood pressure criteria before cocaine infusion
|
1
|
0
|
Baseline Characteristics
SXC-2023 Cocaine Interaction Study
Baseline characteristics by cohort
| Measure |
SXC-2023
n=10 Participants
SXC-2023: 800mg once a day for 7 days
|
SXC-2023 Placebo
n=9 Participants
Placebo: 800mg once a day for 7 days
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.0 year
STANDARD_DEVIATION 8.21 • n=2 Participants
|
34.6 year
STANDARD_DEVIATION 5.46 • n=1 Participants
|
34.8 year
STANDARD_DEVIATION 6.85 • n=3 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=2 Participants
|
2 Participants
n=1 Participants
|
3 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=2 Participants
|
7 Participants
n=1 Participants
|
16 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=2 Participants
|
7 Participants
n=1 Participants
|
14 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=2 Participants
|
2 Participants
n=1 Participants
|
5 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=2 Participants
|
9 Participants
n=1 Participants
|
18 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=2 Participants
|
9 Participants
n=1 Participants
|
19 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Study Days -2,1,2,8,9,11Assessing the number of treatment emergent adverse events using the most recent version of the Medical Dictionary of Regulatory Activities (MedDRA) preferred terms. Adverse events were either reported by the participants or determined by clinically significant abnormal findings on: i. Physical examination ii. Measurement of vital signs (heart rate, blood pressure) iii. Clinical laboratory findings
Outcome measures
| Measure |
SXC-2023
n=10 Participants
SXC-2023: 800mg once a day for 7 days
|
SXC-2023 Placebo
n=9 Participants
Placebo: 800mg once a day for 7 days
|
|---|---|---|
|
Total Number of Treatment-Emergent Adverse Events (Safety and Tolerability) of Oral SXC-2023 Co-administered With Intravenous Cocaine
|
99 events
|
132 events
|
PRIMARY outcome
Timeframe: Study Day 8, 30 min pre till 5 hours post cocaine infusionMaximum heart rate (bpm) after cocaine infusion 20 mg i.v.
Outcome measures
| Measure |
SXC-2023
n=9 Participants
SXC-2023: 800mg once a day for 7 days
|
SXC-2023 Placebo
n=8 Participants
Placebo: 800mg once a day for 7 days
|
|---|---|---|
|
Maximum Pulse (After 20 mg i.v. Cocaine)
|
92.2 BPM
Interval 85.2 to 99.2
|
100.6 BPM
Interval 93.1 to 108.0
|
PRIMARY outcome
Timeframe: Study Day 9, 30 min pre till 5 hours post cocaine infusionMaximum heart rate (bpm) after cocaine infusion 40 mg i.v.
Outcome measures
| Measure |
SXC-2023
n=9 Participants
SXC-2023: 800mg once a day for 7 days
|
SXC-2023 Placebo
n=8 Participants
Placebo: 800mg once a day for 7 days
|
|---|---|---|
|
Maximum Pulse (After 40 mg i.v. Cocaine)
|
105.8 BPM
Interval 99.3 to 112.3
|
112.8 BPM
Interval 105.9 to 119.6
|
PRIMARY outcome
Timeframe: Study Day 8, 30 min pre till 5 hours post cocaine infusionMaximum Systolic Blood Pressure (mmHg) after cocaine infusion 20 mg i.v.
Outcome measures
| Measure |
SXC-2023
n=9 Participants
SXC-2023: 800mg once a day for 7 days
|
SXC-2023 Placebo
n=8 Participants
Placebo: 800mg once a day for 7 days
|
|---|---|---|
|
Maximum Systolic Blood Pressure (After 20 mg i.v. Cocaine)
|
130.7 mmHg
Interval 127.8 to 133.7
|
132.9 mmHg
Interval 129.8 to 136.0
|
PRIMARY outcome
Timeframe: Study Day 9, 30 min pre till 5 hours post cocaine infusionMaximum Systolic Blood Pressure (mmHg) after cocaine infusion 40 mg i.v.
Outcome measures
| Measure |
SXC-2023
n=9 Participants
SXC-2023: 800mg once a day for 7 days
|
SXC-2023 Placebo
n=8 Participants
Placebo: 800mg once a day for 7 days
|
|---|---|---|
|
Maximum Systolic Blood Pressure (After 40 mg i.v. Cocaine)
|
138.3 mmHg
Interval 131.1 to 145.5
|
139.9 mmHg
Interval 132.3 to 147.6
|
PRIMARY outcome
Timeframe: Study Day 8, 30 min pre till 5 hours post cocaine infusionMaximum Diastolic Blood Pressure (mmHg) after cocaine infusion 20 mg i.v.
Outcome measures
| Measure |
SXC-2023
n=9 Participants
SXC-2023: 800mg once a day for 7 days
|
SXC-2023 Placebo
n=8 Participants
Placebo: 800mg once a day for 7 days
|
|---|---|---|
|
Maximum Diastolic Blood Pressure (After 20 mg i.v. Cocaine)
|
82.6 mmHg
Interval 78.7 to 86.5
|
83.6 mmHg
Interval 79.4 to 87.7
|
PRIMARY outcome
Timeframe: Study Day 9, 30 min pre till 5 hours post cocaine infusionMaximum Diastolic Blood Pressure (mmHg) after cocaine infusion 40 mg i.v.
Outcome measures
| Measure |
SXC-2023
n=9 Participants
SXC-2023: 800mg once a day for 7 days
|
SXC-2023 Placebo
n=8 Participants
Placebo: 800mg once a day for 7 days
|
|---|---|---|
|
Maximum Diastolic Blood Pressure (After 40 mg i.v. Cocaine)
|
85.7 mmHg
Interval 81.7 to 89.7
|
87.8 mmHg
Interval 83.6 to 92.0
|
Adverse Events
SXC-2023
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
SXC-2023 Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SXC-2023
n=10 participants at risk
SXC-2023: 800mg once a day for 7 days
|
SXC-2023 Placebo
n=9 participants at risk
Placebo: 800mg once a day for 7 days
|
|---|---|---|
|
Cardiac disorders
palpitations
|
50.0%
5/10 • Number of events 10 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
44.4%
4/9 • Number of events 7 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
|
Eye disorders
Lacrimation increased
|
10.0%
1/10 • Number of events 4 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
11.1%
1/9 • Number of events 2 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
|
Eye disorders
Photophobia
|
10.0%
1/10 • Number of events 3 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
0.00%
0/9 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
|
Eye disorders
Vision blurred
|
10.0%
1/10 • Number of events 2 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
11.1%
1/9 • Number of events 1 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
|
Eye disorders
Visual impairment
|
10.0%
1/10 • Number of events 1 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
0.00%
0/9 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/10 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
11.1%
1/9 • Number of events 5 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/10 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
11.1%
1/9 • Number of events 5 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
|
Gastrointestinal disorders
Dry mouth
|
30.0%
3/10 • Number of events 4 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
22.2%
2/9 • Number of events 3 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Number of events 2 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
55.6%
5/9 • Number of events 11 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
|
General disorders
Feeling abnormal
|
20.0%
2/10 • Number of events 2 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
33.3%
3/9 • Number of events 4 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
|
General disorders
Feeling hot
|
40.0%
4/10 • Number of events 4 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
100.0%
9/9 • Number of events 24 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
|
General disorders
Feeling jittery
|
10.0%
1/10 • Number of events 1 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
22.2%
2/9 • Number of events 2 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
|
General disorders
Feeling of body temperature change
|
10.0%
1/10 • Number of events 1 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
0.00%
0/9 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
|
General disorders
Feeling of relaxation
|
10.0%
1/10 • Number of events 2 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
22.2%
2/9 • Number of events 2 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
10.0%
1/10 • Number of events 2 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
0.00%
0/9 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Number of events 2 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
33.3%
3/9 • Number of events 5 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/10 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
11.1%
1/9 • Number of events 1 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
11.1%
1/9 • Number of events 3 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
|
Nervous system disorders
Paresthesia
|
20.0%
2/10 • Number of events 6 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
22.2%
2/9 • Number of events 2 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
44.4%
4/9 • Number of events 4 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
|
Psychiatric disorders
Bruxism
|
0.00%
0/10 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
33.3%
3/9 • Number of events 9 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
|
Psychiatric disorders
Euphoric mood
|
80.0%
8/10 • Number of events 29 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
66.7%
6/9 • Number of events 23 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
|
Psychiatric disorders
Hypervigilance
|
20.0%
2/10 • Number of events 6 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
11.1%
1/9 • Number of events 1 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
|
Psychiatric disorders
Illusion
|
10.0%
1/10 • Number of events 1 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
0.00%
0/9 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
70.0%
7/10 • Number of events 17 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
77.8%
7/9 • Number of events 18 • from enrollment until follow-up visit (3weeks)
In accordance with FDA reporting requirements, all AEs occurring during the course of the clinical trial were collected, documented, and reported on an Adverse Event Case Report Forms (CRF). The reports included the severity of the event (mild, moderate, severe), and relationship of the AE/SAE to the investigational product in terms of Exposure, Timing of its administration,
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place