Trial Outcomes & Findings for A Study of CLE-100 (Oral Esketamine) in Addition to Standard Antidepressant Drug for Major Depressive Disorder - CLEO Study (NCT NCT04103892)
NCT ID: NCT04103892
Last Updated: 2025-10-14
Results Overview
The MADRS is a validated clinician-administered measurement of depression severity commonly used in clinical trials of depression treatments to select subjects and assess efficacy. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
146 participants
Primary outcome timeframe
29 days
Results posted on
2025-10-14
Participant Flow
Participant milestones
| Measure |
Part A - CLE-100 (Oral Esketamine)
Part A: 1 oral tablet of CLE-100 once daily for 1 week.
CLE-100: 1 tablet of CLE-100 administered once daily
|
Part A - Placebo
Part A: 1 oral tablet of Placebo once daily for 1 week.
placebo: 1 tablet of placebo administered once daily
|
Part B - CLE-100 (Oral Esketamine)
Part B: 1 oral tablet of CLE-100 once daily for 4 weeks.
CLE-100: 1 tablet of CLE-100 administered once daily
|
Part B - Placebo
Part B: 1 oral tablet of Placebo once daily for 4 weeks.
placebo: 1 tablet of placebo administered once daily
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
3
|
72
|
58
|
|
Overall Study
COMPLETED
|
12
|
3
|
66
|
48
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
6
|
10
|
Reasons for withdrawal
| Measure |
Part A - CLE-100 (Oral Esketamine)
Part A: 1 oral tablet of CLE-100 once daily for 1 week.
CLE-100: 1 tablet of CLE-100 administered once daily
|
Part A - Placebo
Part A: 1 oral tablet of Placebo once daily for 1 week.
placebo: 1 tablet of placebo administered once daily
|
Part B - CLE-100 (Oral Esketamine)
Part B: 1 oral tablet of CLE-100 once daily for 4 weeks.
CLE-100: 1 tablet of CLE-100 administered once daily
|
Part B - Placebo
Part B: 1 oral tablet of Placebo once daily for 4 weeks.
placebo: 1 tablet of placebo administered once daily
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
2
|
5
|
|
Overall Study
Requirement of prohibited concomitant medication
|
0
|
0
|
1
|
1
|
Baseline Characteristics
A Study of CLE-100 (Oral Esketamine) in Addition to Standard Antidepressant Drug for Major Depressive Disorder - CLEO Study
Baseline characteristics by cohort
| Measure |
Part A - CLE-100 (Oral Esketamine)
n=13 Participants
Part A: 1 oral tablet of CLE-100 once daily for 1 week.
CLE-100: 1 tablet of CLE-100 administered once daily
|
Part A - Placebo
n=3 Participants
Part A: 1 oral tablet of Placebo once daily for 1 week.
placebo: 1 tablet of placebo administered once daily
|
Part B - CLE-100 (Oral Esketamine)
n=72 Participants
Part B: 1 oral tablet of CLE-100 once daily for 4 weeks.
CLE-100: 1 tablet of CLE-100 administered once daily
|
Part B - Placebo
n=58 Participants
Part B: 1 oral tablet of Placebo once daily for 4 weeks.
placebo: 1 tablet of placebo administered once daily
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
50.23 years
STANDARD_DEVIATION 9.99 • n=5 Participants
|
49.00 years
STANDARD_DEVIATION 7.55 • n=7 Participants
|
42.79 years
STANDARD_DEVIATION 13.24 • n=5 Participants
|
46.19 years
STANDARD_DEVIATION 13.14 • n=4 Participants
|
44.93 years
STANDARD_DEVIATION 12.98 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
101 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
104 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
103 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
Puerto Rico
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
3 participants
n=7 Participants
|
70 participants
n=5 Participants
|
58 participants
n=4 Participants
|
144 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 29 daysPopulation: The Full Analysis Set (FAS), which is a subset of the ITT Analysis Set, includes all data collected while on study drug for all randomized subjects who received at least 1 dose of study drug during Part B and have both Baseline and at least 1 post-baseline MADRS total score. This Analysis Set serves as the principal analysis set for inference.
The MADRS is a validated clinician-administered measurement of depression severity commonly used in clinical trials of depression treatments to select subjects and assess efficacy. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.
Outcome measures
| Measure |
Part B - CLE-100 (Oral Esketamine)
n=70 Participants
Part B: 1 oral tablet of CLE-100 once daily for 4 weeks.
CLE-100: 1 tablet of CLE-100 administered once daily
|
Part B - Placebo
n=55 Participants
Part B: 1 oral tablet of Placebo once daily for 4 weeks.
placebo: 1 tablet of placebo administered once daily
|
|---|---|---|
|
Part B - Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score
|
-10.72 units on a scale
Standard Error 1.13
|
-9.46 units on a scale
Standard Error 1.31
|
POST_HOC outcome
Timeframe: 29 daysPopulation: 2022 cohort (corresponding to a post-acute phase of the COVID-19 pandemic) of the Full Analysis Set (FAS) includes all data collected while on study drug for all randomized subjects in 2022 who received at least 1 dose of study drug during Part B and have both Baseline and at least 1 post-baseline MADRS total score. This Analysis Set serves as the principal analysis set for inference.
The MADRS is a validated clinician-administered measurement of depression severity commonly used in clinical trials of depression treatments to select subjects and assess efficacy. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.
Outcome measures
| Measure |
Part B - CLE-100 (Oral Esketamine)
n=35 Participants
Part B: 1 oral tablet of CLE-100 once daily for 4 weeks.
CLE-100: 1 tablet of CLE-100 administered once daily
|
Part B - Placebo
n=30 Participants
Part B: 1 oral tablet of Placebo once daily for 4 weeks.
placebo: 1 tablet of placebo administered once daily
|
|---|---|---|
|
Part B - Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score in 2022 Cohort (Corresponding to a Post-acute Phase of the COVID-19 Pandemic)
|
-12.96 units on a scale
Standard Error 1.60
|
-7.68 units on a scale
Standard Error 1.84
|
Adverse Events
Part A - CLE-100 (Oral Esketamine)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A - Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B - CLE-100 (Oral Esketamine)
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Part B - Placebo
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A - CLE-100 (Oral Esketamine)
n=13 participants at risk
Part A: 1 oral tablet of CLE-100 once daily for 1 week.
CLE-100: 1 tablet of CLE-100 administered once daily
|
Part A - Placebo
n=3 participants at risk
Part A: 1 oral tablet of Placebo once daily for 1 week.
placebo: 1 tablet of placebo administered once daily
|
Part B - CLE-100 (Oral Esketamine)
n=72 participants at risk
Part B: 1 oral tablet of CLE-100 once daily for 4 weeks.
CLE-100: 1 tablet of CLE-100 administered once daily
|
Part B - Placebo
n=57 participants at risk
Part B: 1 oral tablet of Placebo once daily for 4 weeks.
placebo: 1 tablet of placebo administered once daily
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Eye disorders
Vision blurred
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
2.8%
2/72 • Number of events 4 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Eye disorders
Visual impairment
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
33.3%
1/3 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/72 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
8.3%
6/72 • Number of events 10 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
4.2%
3/72 • Number of events 4 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
1.8%
1/57 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/72 • Part A: 2 weeks; Part B: 6 weeks
|
1.8%
1/57 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
|
General disorders
Fatigue
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
1.8%
1/57 • Number of events 2 • Part A: 2 weeks; Part B: 6 weeks
|
|
General disorders
Feeling abnormal
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
General disorders
Feeling cold
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Infections and infestations
COVID-19
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
5.3%
3/57 • Number of events 3 • Part A: 2 weeks; Part B: 6 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
2.8%
2/72 • Number of events 2 • Part A: 2 weeks; Part B: 6 weeks
|
1.8%
1/57 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
2.8%
2/72 • Number of events 2 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
1.8%
1/57 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
|
Infections and infestations
Laryngitis
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/72 • Part A: 2 weeks; Part B: 6 weeks
|
1.8%
1/57 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
1/13 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/72 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
7.7%
1/13 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/72 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
1.8%
1/57 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 2 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/72 • Part A: 2 weeks; Part B: 6 weeks
|
1.8%
1/57 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
|
Investigations
Weight increased
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/72 • Part A: 2 weeks; Part B: 6 weeks
|
1.8%
1/57 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/72 • Part A: 2 weeks; Part B: 6 weeks
|
3.5%
2/57 • Number of events 2 • Part A: 2 weeks; Part B: 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
1.8%
1/57 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/72 • Part A: 2 weeks; Part B: 6 weeks
|
1.8%
1/57 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
12.5%
9/72 • Number of events 11 • Part A: 2 weeks; Part B: 6 weeks
|
8.8%
5/57 • Number of events 5 • Part A: 2 weeks; Part B: 6 weeks
|
|
Nervous system disorders
Dizziness
|
30.8%
4/13 • Number of events 4 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
13.9%
10/72 • Number of events 17 • Part A: 2 weeks; Part B: 6 weeks
|
1.8%
1/57 • Number of events 2 • Part A: 2 weeks; Part B: 6 weeks
|
|
Nervous system disorders
Somnolence
|
15.4%
2/13 • Number of events 2 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
11.1%
8/72 • Number of events 9 • Part A: 2 weeks; Part B: 6 weeks
|
1.8%
1/57 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
|
Nervous system disorders
Sedation
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/72 • Part A: 2 weeks; Part B: 6 weeks
|
3.5%
2/57 • Number of events 4 • Part A: 2 weeks; Part B: 6 weeks
|
|
Nervous system disorders
Lethargy
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 6 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Nervous system disorders
Ataxia
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/72 • Part A: 2 weeks; Part B: 6 weeks
|
1.8%
1/57 • Number of events 2 • Part A: 2 weeks; Part B: 6 weeks
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/72 • Part A: 2 weeks; Part B: 6 weeks
|
7.0%
4/57 • Number of events 4 • Part A: 2 weeks; Part B: 6 weeks
|
|
Psychiatric disorders
Dissociation
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
2.8%
2/72 • Number of events 3 • Part A: 2 weeks; Part B: 6 weeks
|
1.8%
1/57 • Number of events 3 • Part A: 2 weeks; Part B: 6 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
4.2%
3/72 • Number of events 4 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
3.5%
2/57 • Number of events 2 • Part A: 2 weeks; Part B: 6 weeks
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
1.8%
1/57 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
|
Psychiatric disorders
Anger
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Psychiatric disorders
Bradyphrenia
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Psychiatric disorders
Enuresis
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/72 • Part A: 2 weeks; Part B: 6 weeks
|
1.8%
1/57 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/72 • Part A: 2 weeks; Part B: 6 weeks
|
1.8%
1/57 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
2.8%
2/72 • Number of events 2 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/72 • Part A: 2 weeks; Part B: 6 weeks
|
1.8%
1/57 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/72 • Part A: 2 weeks; Part B: 6 weeks
|
1.8%
1/57 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/57 • Part A: 2 weeks; Part B: 6 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/13 • Part A: 2 weeks; Part B: 6 weeks
|
0.00%
0/3 • Part A: 2 weeks; Part B: 6 weeks
|
1.4%
1/72 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
1.8%
1/57 • Number of events 1 • Part A: 2 weeks; Part B: 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After the multicenter publication or 18 months after completion of the Study, whichever occurs first, Institution may itself publish the results of its data from the Study. Institution and Principal Investigator shall provide Sponsor with an advance copy of any proposed publication or oral presentation at least 60 days prior to the planned date of submission or presentation and Sponsor shall have 60 days to review the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER