Trial Outcomes & Findings for Lisdexamfetamine Dimesylate (LDX) Pilot Cognition Study to Evaluate the Utility of a Standardized Battery of Tests in Adults With Attention-Deficit Hyperactivity Disorder (ADHD) (NCT NCT01010750)
NCT ID: NCT01010750
Last Updated: 2021-06-14
Results Overview
The Power of Attention score reflects the ability to focus attention, and is calculated as the sum of the reaction time, measured in milliseconds, from 3 attention tests (Simple Reaction Time, Choice Reaction Time, and Digit Vigilance Speed). Faster performance (lower times) reflects more intense concentration. A decrease in the Power of Attention score indicates improvement.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
pre-dose and at 1, 2, 3, 4, 5, 8, 12, 14 and 16 hours post-dose on Day 7
Results posted on
2021-06-14
Participant Flow
Each of the 3 treatment regimens was administered daily for 7 days (a total of 21 days of treatment). There was no washout between regimens.
Participant milestones
| Measure |
LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo
Lisdexamfetamine Dimesylate (LDX) 50 mg + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo first, then MAS-IR 20 mg + LDX placebo, then LDX placebo + MAS-IR placebo
|
LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg
LDX 50 mg + MAS-IR placebo first, then LDX placebo + MAS-IR placebo, then MAS-IR 20 mg + LDX placebo
|
Placebo First, Then LDX 50 mg, Then MAS-IR 20 mg
LDX placebo + MAS-IR placebo first, then LDX 50 mg + MAS-IR placebo, then MAS-IR 20 mg + LDX placebo
|
Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg
LDX placebo + MAS-IR placebo first, then MAS-IR 20 mg + LDX placebo, then LDX 50 mg + MAS-IR placebo
|
MAS-IR 20 mg First, Then LDX 50 mg, Then Placebo
MAS-IR 20 mg + LDX placebo first, then LDX 50 mg + MAS-IR placebo, then LDX placebo + MAS-IR placebo
|
MAS-IR 20 mg First, Then Placebo, Then LDX 50 mg
MAS-IR 20 mg + LDX placebo first, then LDX placebo + MAS-IR placebo, then LDX 50 mg + MAS-IR placebo
|
|---|---|---|---|---|---|---|
|
First Intervention
STARTED
|
3
|
4
|
3
|
3
|
2
|
3
|
|
First Intervention
COMPLETED
|
3
|
4
|
3
|
3
|
2
|
3
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention
STARTED
|
3
|
4
|
3
|
3
|
2
|
3
|
|
Second Intervention
COMPLETED
|
3
|
3
|
3
|
3
|
2
|
3
|
|
Second Intervention
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Third Intervention
STARTED
|
3
|
3
|
3
|
3
|
2
|
3
|
|
Third Intervention
COMPLETED
|
3
|
3
|
3
|
3
|
2
|
3
|
|
Third Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo
Lisdexamfetamine Dimesylate (LDX) 50 mg + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo first, then MAS-IR 20 mg + LDX placebo, then LDX placebo + MAS-IR placebo
|
LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg
LDX 50 mg + MAS-IR placebo first, then LDX placebo + MAS-IR placebo, then MAS-IR 20 mg + LDX placebo
|
Placebo First, Then LDX 50 mg, Then MAS-IR 20 mg
LDX placebo + MAS-IR placebo first, then LDX 50 mg + MAS-IR placebo, then MAS-IR 20 mg + LDX placebo
|
Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg
LDX placebo + MAS-IR placebo first, then MAS-IR 20 mg + LDX placebo, then LDX 50 mg + MAS-IR placebo
|
MAS-IR 20 mg First, Then LDX 50 mg, Then Placebo
MAS-IR 20 mg + LDX placebo first, then LDX 50 mg + MAS-IR placebo, then LDX placebo + MAS-IR placebo
|
MAS-IR 20 mg First, Then Placebo, Then LDX 50 mg
MAS-IR 20 mg + LDX placebo first, then LDX placebo + MAS-IR placebo, then LDX 50 mg + MAS-IR placebo
|
|---|---|---|---|---|---|---|
|
Second Intervention
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Lisdexamfetamine Dimesylate (LDX) Pilot Cognition Study to Evaluate the Utility of a Standardized Battery of Tests in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
Baseline characteristics by cohort
| Measure |
LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo
n=3 Participants
|
LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg
n=4 Participants
|
Placebo First, Them LDX 50 mg, Then MAS-IR 20 mg
n=3 Participants
|
Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg
n=3 Participants
|
MAS-IR 20 mg First, Then LDX 50 mg, Then Placebo
n=2 Participants
|
MAS-IR 20 mg First, Then Placebo, Then LDX 50 mg
n=3 Participants
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
25.0 years
STANDARD_DEVIATION 1.00 • n=99 Participants
|
24.8 years
STANDARD_DEVIATION 6.70 • n=107 Participants
|
30.3 years
STANDARD_DEVIATION 6.11 • n=206 Participants
|
31.3 years
STANDARD_DEVIATION 11.37 • n=7 Participants
|
53.0 years
STANDARD_DEVIATION 0.00 • n=31 Participants
|
30.0 years
STANDARD_DEVIATION 11.36 • n=30 Participants
|
30.8 years
STANDARD_DEVIATION 10.75 • n=3 Participants
|
|
Age, Customized
<18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Age, Customized
Between 18 and 55 years
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
18 Participants
n=3 Participants
|
|
Age, Customized
>=56 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
11 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
18 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: pre-dose and at 1, 2, 3, 4, 5, 8, 12, 14 and 16 hours post-dose on Day 7Population: The Pharmacodynamic Set (PD) is all subjects in the Safety Set who had at least 1 post-dose assessment of the pharmacodynamic variables. The Safety Set contains all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
The Power of Attention score reflects the ability to focus attention, and is calculated as the sum of the reaction time, measured in milliseconds, from 3 attention tests (Simple Reaction Time, Choice Reaction Time, and Digit Vigilance Speed). Faster performance (lower times) reflects more intense concentration. A decrease in the Power of Attention score indicates improvement.
Outcome measures
| Measure |
LDX 50 mg
n=18 Participants
|
MAS-IR 20 mg
n=17 Participants
|
Placebo
n=17 Participants
|
|---|---|---|---|
|
Power of Attention Score
3 hours post-dose
|
1219.1 milliseconds
Standard Error 33.428
|
1229.6 milliseconds
Standard Error 37.865
|
1301.0 milliseconds
Standard Error 40.864
|
|
Power of Attention Score
12 hours post-dose
|
1232.4 milliseconds
Standard Error 48.183
|
1239.3 milliseconds
Standard Error 38.465
|
1262.1 milliseconds
Standard Error 40.795
|
|
Power of Attention Score
half an hour prior to dosing
|
1260.7 milliseconds
Standard Error 34.000
|
1324.1 milliseconds
Standard Error 47.142
|
1272.8 milliseconds
Standard Error 33.729
|
|
Power of Attention Score
1 hour post-dose
|
1244.6 milliseconds
Standard Error 32.887
|
1307.4 milliseconds
Standard Error 42.908
|
1253.1 milliseconds
Standard Error 24.174
|
|
Power of Attention Score
2 hours post-dose
|
1315.5 milliseconds
Standard Error 67.246
|
1255.0 milliseconds
Standard Error 33.905
|
1296.2 milliseconds
Standard Error 39.808
|
|
Power of Attention Score
4 hours post-dose
|
1225.9 milliseconds
Standard Error 40.192
|
1236.5 milliseconds
Standard Error 36.839
|
1275.4 milliseconds
Standard Error 35.302
|
|
Power of Attention Score
5 hours post-dose
|
1179.6 milliseconds
Standard Error 35.022
|
1251.4 milliseconds
Standard Error 42.607
|
1330.3 milliseconds
Standard Error 49.623
|
|
Power of Attention Score
8 hours post-dose
|
1212.0 milliseconds
Standard Error 36.113
|
1259.3 milliseconds
Standard Error 35.883
|
1304.5 milliseconds
Standard Error 43.802
|
|
Power of Attention Score
14 hours post-dose
|
1199.3 milliseconds
Standard Error 35.947
|
1270.1 milliseconds
Standard Error 39.539
|
1270.5 milliseconds
Standard Error 44.814
|
|
Power of Attention Score
16 hours post-dose
|
1202.6 milliseconds
Standard Error 37.135
|
1255.9 milliseconds
Standard Error 36.378
|
1270.3 milliseconds
Standard Error 48.581
|
SECONDARY outcome
Timeframe: 2 and 14 hours post-dose on Day 7Population: PD
Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 \* (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.
Outcome measures
| Measure |
LDX 50 mg
n=18 Participants
|
MAS-IR 20 mg
n=17 Participants
|
Placebo
n=17 Participants
|
|---|---|---|---|
|
Conners Adult ADHD Rating Scales-Self Report: Short Version (CAARS-S:S) Subscale Total Score (T-Score): Inattention/Memory Problems
2 hours post-dose
|
66.16 Units on a scale
Standard Error 2.927
|
63.39 Units on a scale
Standard Error 3.319
|
64.92 Units on a scale
Standard Error 2.775
|
|
Conners Adult ADHD Rating Scales-Self Report: Short Version (CAARS-S:S) Subscale Total Score (T-Score): Inattention/Memory Problems
14 hours post-dose
|
65.78 Units on a scale
Standard Error 3.029
|
64.45 Units on a scale
Standard Error 2.483
|
66.33 Units on a scale
Standard Error 2.398
|
SECONDARY outcome
Timeframe: 2 and 14 hours post-dose on Day 7Population: PD
Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 \* (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.
Outcome measures
| Measure |
LDX 50 mg
n=18 Participants
|
MAS-IR 20 mg
n=17 Participants
|
Placebo
n=17 Participants
|
|---|---|---|---|
|
CAARS-S:S Subscale T-Score: Hyperactivity/Restlessness
2 hours post-dose
|
64.21 Units on a scale
Standard Error 2.996
|
63.62 Units on a scale
Standard Error 3.372
|
63.28 Units on a scale
Standard Error 3.063
|
|
CAARS-S:S Subscale T-Score: Hyperactivity/Restlessness
14 hours post-dose
|
65.08 Units on a scale
Standard Error 2.837
|
63.41 Units on a scale
Standard Error 2.763
|
65.74 Units on a scale
Standard Error 2.597
|
SECONDARY outcome
Timeframe: 2 and 14 hours post-dose on Day 7Population: PD
Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 \* (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.
Outcome measures
| Measure |
LDX 50 mg
n=18 Participants
|
MAS-IR 20 mg
n=17 Participants
|
Placebo
n=17 Participants
|
|---|---|---|---|
|
CAARS-S:S Subscale T-Score: Impulsivity/Emotional Liability
2 hours post-dose
|
55.46 Units on a scale
Standard Error 2.931
|
54.58 Units on a scale
Standard Error 3.470
|
54.66 Units on a scale
Standard Error 3.421
|
|
CAARS-S:S Subscale T-Score: Impulsivity/Emotional Liability
14 hours post-dose
|
57.82 Units on a scale
Standard Error 3.479
|
51.53 Units on a scale
Standard Error 2.802
|
55.78 Units on a scale
Standard Error 2.773
|
SECONDARY outcome
Timeframe: 2 and 14 hours post-dose on Day 7Population: PD
Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 \* (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.
Outcome measures
| Measure |
LDX 50 mg
n=18 Participants
|
MAS-IR 20 mg
n=17 Participants
|
Placebo
n=17 Participants
|
|---|---|---|---|
|
CAARS-S:S Subscale T-Score: Problems With Self-Concept
2 hours post-dose
|
58.71 Units on a scale
Standard Error 3.533
|
59.78 Units on a scale
Standard Error 3.390
|
58.40 Units on a scale
Standard Error 3.279
|
|
CAARS-S:S Subscale T-Score: Problems With Self-Concept
14 hours post-dose
|
59.68 Units on a scale
Standard Error 3.841
|
59.54 Units on a scale
Standard Error 3.574
|
59.68 Units on a scale
Standard Error 3.055
|
SECONDARY outcome
Timeframe: 2 and 14 hours post-dose on Day 7Population: PD
Consists of 12 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 \* (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.
Outcome measures
| Measure |
LDX 50 mg
n=18 Participants
|
MAS-IR 20 mg
n=17 Participants
|
Placebo
n=17 Participants
|
|---|---|---|---|
|
CAARS-S:S Subscale T-Score: Attention Deficit Hyperactivity Disorder (ADHD) Index
2 hours post-dose
|
64.82 Units on a scale
Standard Error 3.147
|
63.90 Units on a scale
Standard Error 3.766
|
64.59 Units on a scale
Standard Error 3.681
|
|
CAARS-S:S Subscale T-Score: Attention Deficit Hyperactivity Disorder (ADHD) Index
14 hours post-dose
|
66.56 Units on a scale
Standard Error 3.714
|
63.09 Units on a scale
Standard Error 2.945
|
64.85 Units on a scale
Standard Error 3.118
|
Adverse Events
LDX 50 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
MAS-IR 20 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LDX 50 mg
n=18 participants at risk
|
MAS-IR 20 mg
n=17 participants at risk
|
Placebo
n=17 participants at risk
|
|---|---|---|---|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • Number of events 1
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
5.9%
1/17 • Number of events 1
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
5.9%
1/17 • Number of events 1
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Number of events 1
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
5.9%
1/17 • Number of events 1
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
17.6%
3/17 • Number of events 3
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
Nervous system disorders
Paraesthesia
|
5.6%
1/18 • Number of events 1
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
0.00%
0/17
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
0.00%
0/17
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
Nervous system disorders
Sedation
|
0.00%
0/18
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
5.9%
1/17 • Number of events 1
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
0.00%
0/17
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
Psychiatric disorders
Bruxism
|
5.6%
1/18 • Number of events 1
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
0.00%
0/17
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
0.00%
0/17
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
Psychiatric disorders
Insomnia
|
5.6%
1/18 • Number of events 1
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
5.9%
1/17 • Number of events 1
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
0.00%
0/17
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/18
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
5.9%
1/17 • Number of events 1
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
0.00%
0/17
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
Psychiatric disorders
Obsessive-Compulsive Disorder
|
5.6%
1/18 • Number of events 1
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
0.00%
0/17
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
0.00%
0/17
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
Renal and urinary disorders
Dysuria
|
5.6%
1/18 • Number of events 1
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
0.00%
0/17
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
0.00%
0/17
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
Renal and urinary disorders
Micturition Disorder
|
5.6%
1/18 • Number of events 1
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
0.00%
0/17
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
5.9%
1/17 • Number of events 1
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.6%
1/18 • Number of events 1
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
11.8%
2/17 • Number of events 2
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
0.00%
0/17
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
Cardiac disorders
Palpitations
|
5.6%
1/18 • Number of events 1
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
0.00%
0/17
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
0.00%
0/17
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/18
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
5.9%
1/17 • Number of events 1
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
0.00%
0/17
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/18
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
0.00%
0/17
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
5.9%
1/17 • Number of events 1
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Dry Mouth
|
33.3%
6/18 • Number of events 8
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
23.5%
4/17 • Number of events 6
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
17.6%
3/17 • Number of events 3
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18 • Number of events 1
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
5.9%
1/17 • Number of events 1
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
0.00%
0/17
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
General disorders
Chest Pain
|
0.00%
0/18
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
0.00%
0/17
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
5.9%
1/17 • Number of events 1
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
General disorders
Fatigue
|
5.6%
1/18 • Number of events 1
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
0.00%
0/17
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
0.00%
0/17
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
General disorders
Feeling Jittery
|
5.6%
1/18 • Number of events 1
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
11.8%
2/17 • Number of events 3
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
0.00%
0/17
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
General disorders
Irritability
|
5.6%
1/18 • Number of events 1
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
0.00%
0/17
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
0.00%
0/17
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
Investigations
Heart Rate Increased
|
11.1%
2/18 • Number of events 2
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
0.00%
0/17
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
0.00%
0/17
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
16.7%
3/18 • Number of events 3
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
23.5%
4/17 • Number of events 5
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
5.9%
1/17 • Number of events 1
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Sensation of Heaviness
|
0.00%
0/18
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
5.9%
1/17 • Number of events 1
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
0.00%
0/17
Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER