Trial Outcomes & Findings for A Study of the Safety and Tolerability of AZD5213 Effect on Sleep for Patients With Alzheimer's/Cognitive Impairment (NCT NCT01548287)
NCT ID: NCT01548287
Last Updated: 2017-02-07
Results Overview
Total sleep time (TST) is defined as the total time in minutes, that subjects were determined to be in a sleep state by polysomnography (PSG) measurement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
164 participants
Primary outcome timeframe
Baseline and Week 4.
Results posted on
2017-02-07
Participant Flow
164 subjects signed informed consent and 83 failed to qualify at the first screening visit for participation in the study.
Participant milestones
| Measure |
AZD5213 Dose A
AZD5213 AZD 0.5 mg daily
|
AZD5213 Dose B
AZD 5213 2.0 mg daily
|
AZD5213 Dose C
AZD5213 6.0 mg daily
|
Placebo
Placebo daily
|
Screening Only
Screening period only, not randomized
|
|---|---|---|---|---|---|
|
Screening
STARTED
|
19
|
22
|
20
|
20
|
83
|
|
Screening
COMPLETED
|
19
|
22
|
20
|
20
|
0
|
|
Screening
NOT COMPLETED
|
0
|
0
|
0
|
0
|
83
|
|
Randomized Period
STARTED
|
19
|
22
|
20
|
20
|
0
|
|
Randomized Period
COMPLETED
|
19
|
20
|
13
|
20
|
0
|
|
Randomized Period
NOT COMPLETED
|
0
|
2
|
7
|
0
|
0
|
Reasons for withdrawal
| Measure |
AZD5213 Dose A
AZD5213 AZD 0.5 mg daily
|
AZD5213 Dose B
AZD 5213 2.0 mg daily
|
AZD5213 Dose C
AZD5213 6.0 mg daily
|
Placebo
Placebo daily
|
Screening Only
Screening period only, not randomized
|
|---|---|---|---|---|---|
|
Screening
No reason provided
|
0
|
0
|
0
|
0
|
9
|
|
Screening
Did not meet eligibility criteria
|
0
|
0
|
0
|
0
|
74
|
|
Randomized Period
Did not meet inclusion criteria
|
0
|
0
|
2
|
0
|
0
|
|
Randomized Period
Adverse Event
|
0
|
2
|
5
|
0
|
0
|
Baseline Characteristics
A Study of the Safety and Tolerability of AZD5213 Effect on Sleep for Patients With Alzheimer's/Cognitive Impairment
Baseline characteristics by cohort
| Measure |
AZD5213 Dose A
n=19 Participants
AZD5213 AZD 0.5 mg daily
|
AZD5213 Dose B
n=22 Participants
AZD 5213 2.0 mg daily
|
AZD5213 Dose C
n=20 Participants
AZD5213 6.0 mg daily
|
Placebo
n=20 Participants
Placebo daily
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
66.1 years
STANDARD_DEVIATION 8.02 • n=5 Participants
|
65.1 years
STANDARD_DEVIATION 8.04 • n=7 Participants
|
69.3 years
STANDARD_DEVIATION 10.32 • n=5 Participants
|
64.2 years
STANDARD_DEVIATION 7.62 • n=4 Participants
|
66.1 years
STANDARD_DEVIATION 8.62 • n=21 Participants
|
|
Gender
Female
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Gender
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Mini-Mental State Examination
|
27.2 Scores on scale
STANDARD_DEVIATION 1.38 • n=5 Participants
|
27.0 Scores on scale
STANDARD_DEVIATION 2.01 • n=7 Participants
|
26.1 Scores on scale
STANDARD_DEVIATION 1.62 • n=5 Participants
|
27.0 Scores on scale
STANDARD_DEVIATION 1.88 • n=4 Participants
|
26.8 Scores on scale
STANDARD_DEVIATION 1.77 • n=21 Participants
|
|
Alzheimers disease (AD)/Mild cognitive impairment (MCI)
AD
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Alzheimers disease (AD)/Mild cognitive impairment (MCI)
MCI
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
|
Concomitant donepezil administration
Yes
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Concomitant donepezil administration
No
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
72 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 4.Population: Primary analysis set
Total sleep time (TST) is defined as the total time in minutes, that subjects were determined to be in a sleep state by polysomnography (PSG) measurement.
Outcome measures
| Measure |
AZD5213 Dose A
n=19 Participants
AZD5213 AZD 0.5 mg daily
|
AZD5213 Dose B
n=20 Participants
AZD 5213 2.0 mg daily
|
AZD5213 Dose C
n=13 Participants
AZD5213 6.0 mg daily
|
Placebo
n=20 Participants
Placebo daily
|
|---|---|---|---|---|
|
Change From Baseline in Total Sleep Time (TST) After 4 Weeks of Treatment, Based on PSG Measurement.
|
6.43 Minutes
Interval -12.74 to 25.61
|
-12.53 Minutes
Interval -31.32 to 6.27
|
-19.41 Minutes
Interval -41.91 to 3.08
|
14.48 Minutes
Interval -4.31 to 33.27
|
SECONDARY outcome
Timeframe: Baseline and Week 4.Population: Primary analysis set
Outcome measures
| Measure |
AZD5213 Dose A
n=19 Participants
AZD5213 AZD 0.5 mg daily
|
AZD5213 Dose B
n=20 Participants
AZD 5213 2.0 mg daily
|
AZD5213 Dose C
n=13 Participants
AZD5213 6.0 mg daily
|
Placebo
n=20 Participants
Placebo daily
|
|---|---|---|---|---|
|
Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on PSG Measurements.
|
0.08 % change
Interval -3.15 to 3.32
|
-1.51 % change
Interval -4.68 to 1.66
|
-2.82 % change
Interval -6.61 to 0.97
|
0.96 % change
Interval -2.2 to 4.13
|
SECONDARY outcome
Timeframe: Baseline and Week 4.Population: Primary analysis set
Outcome measures
| Measure |
AZD5213 Dose A
n=19 Participants
AZD5213 AZD 0.5 mg daily
|
AZD5213 Dose B
n=20 Participants
AZD 5213 2.0 mg daily
|
AZD5213 Dose C
n=13 Participants
AZD5213 6.0 mg daily
|
Placebo
n=20 Participants
Placebo daily
|
|---|---|---|---|---|
|
Change From Baseline in Latency to Persistent Sleep After 4 Weeks of Treatment, Based on PSG Measurements.
|
-2.23 Rank transformed duration (minutes)
Interval -18.44 to 13.98
|
14.48 Rank transformed duration (minutes)
Interval -1.34 to 30.31
|
-5.84 Rank transformed duration (minutes)
Interval -24.91 to 13.23
|
-5.68 Rank transformed duration (minutes)
Interval -21.54 to 10.18
|
SECONDARY outcome
Timeframe: Baseline and Week 4.Population: Subset of Primary Analysis Set with valid actigraphy data
Change from baseline in night total sleep time after 4 weeks of treatment: assessed if valid baseline and week 4 actigraphy data
Outcome measures
| Measure |
AZD5213 Dose A
n=17 Participants
AZD5213 AZD 0.5 mg daily
|
AZD5213 Dose B
n=19 Participants
AZD 5213 2.0 mg daily
|
AZD5213 Dose C
n=11 Participants
AZD5213 6.0 mg daily
|
Placebo
n=17 Participants
Placebo daily
|
|---|---|---|---|---|
|
Change From Baseline in Night Total Sleep Time After 4 Weeks of Treatment, Based on Actigraphy Recording.
|
7.07 Minutes
Interval -14.88 to 29.02
|
-12.42 Minutes
Interval -34.92 to 10.07
|
-18.97 Minutes
Interval -45.96 to 8.02
|
-7.51 Minutes
Interval -29.47 to 14.44
|
SECONDARY outcome
Timeframe: Baseline and Week 4.Population: Subset of Primary Analysis Set with valid actigraphy data
Change from baseline in latency of persistent sleep after 4 weeks of treatment, based on participants with valid baseline and week 4 actigraphy data
Outcome measures
| Measure |
AZD5213 Dose A
n=17 Participants
AZD5213 AZD 0.5 mg daily
|
AZD5213 Dose B
n=19 Participants
AZD 5213 2.0 mg daily
|
AZD5213 Dose C
n=11 Participants
AZD5213 6.0 mg daily
|
Placebo
n=17 Participants
Placebo daily
|
|---|---|---|---|---|
|
Change From Baseline in Latency of Persistent Sleep After 4 Weeks of Treatment, Based on Actigraphy Recording.
|
1.77 Minutes
Interval -5.41 to 8.96
|
9.84 Minutes
Interval 2.86 to 16.81
|
-6.85 Minutes
Interval -15.5 to 1.81
|
2.70 Minutes
Interval -4.65 to 10.06
|
SECONDARY outcome
Timeframe: Baseline and Week 4.Population: Subset of Primary Analysis Population with valid actigraphy data
Change from baseline in sleep efficiency after 4 weeks of treatment, based on participants with valid baseline and week 4 actigraphy data
Outcome measures
| Measure |
AZD5213 Dose A
n=17 Participants
AZD5213 AZD 0.5 mg daily
|
AZD5213 Dose B
n=19 Participants
AZD 5213 2.0 mg daily
|
AZD5213 Dose C
n=11 Participants
AZD5213 6.0 mg daily
|
Placebo
n=17 Participants
Placebo daily
|
|---|---|---|---|---|
|
Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on Actigraphy Recording.
|
-0.05 % (efficiency=% of time asleep)
Interval -3.65 to 3.55
|
-3.20 % (efficiency=% of time asleep)
Interval -6.69 to 0.3
|
-1.92 % (efficiency=% of time asleep)
Interval -6.2 to 2.35
|
-1.83 % (efficiency=% of time asleep)
Interval -5.46 to 1.8
|
Adverse Events
AZD5213 Dose A
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
AZD5213 Dose B
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
AZD5213 Dose C
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD5213 Dose A
n=19 participants at risk
AZD5213 AZD 0.5 mg daily
|
AZD5213 Dose B
n=22 participants at risk
AZD 5213 2.0 mg daily
|
AZD5213 Dose C
n=20 participants at risk
AZD5213 6.0 mg daily
|
Placebo
n=20 participants at risk
Placebo daily
|
|---|---|---|---|---|
|
Nervous system disorders
Transient ischemic attack
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
Other adverse events
| Measure |
AZD5213 Dose A
n=19 participants at risk
AZD5213 AZD 0.5 mg daily
|
AZD5213 Dose B
n=22 participants at risk
AZD 5213 2.0 mg daily
|
AZD5213 Dose C
n=20 participants at risk
AZD5213 6.0 mg daily
|
Placebo
n=20 participants at risk
Placebo daily
|
|---|---|---|---|---|
|
Psychiatric disorders
Insomnia
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
18.2%
4/22 • Number of events 4 • From first dose of study drug through the follow-up (up to 38 days total)
|
40.0%
8/20 • Number of events 9 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Nervous system disorders
Headache
|
5.3%
1/19 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
18.2%
4/22 • Number of events 4 • From first dose of study drug through the follow-up (up to 38 days total)
|
25.0%
5/20 • Number of events 6 • From first dose of study drug through the follow-up (up to 38 days total)
|
10.0%
2/20 • Number of events 2 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
4.5%
1/22 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
10.0%
2/20 • Number of events 2 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
9.1%
2/22 • Number of events 3 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
15.0%
3/20 • Number of events 3 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
4.5%
1/22 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Gastrointestinal disorders
Dyspesia
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
10.0%
2/20 • Number of events 2 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Injury, poisoning and procedural complications
Fall
|
5.3%
1/19 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
4.5%
1/22 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Vascular disorders
Hot flush
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
4.5%
1/22 • Number of events 2 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Psychiatric disorders
Libido increased
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
4.5%
1/22 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
10.0%
2/20 • Number of events 2 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Investigations
Blood pressure increased
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
4.5%
1/22 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
10.0%
2/20 • Number of events 2 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
4.5%
1/22 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Ear and labyrinth disorders
Hyperacusis
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Gastrointestinal disorders
Toothache
|
5.3%
1/19 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
General disorders
Feeling hot
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
General disorders
Irritability
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
4.5%
1/22 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
General disorders
Pyrexia
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
General disorders
Thirst
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
General disorders
Malaise
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
4.5%
1/22 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.3%
1/19 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Injury, poisoning and procedural complications
Laceration
|
5.3%
1/19 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Injury, poisoning and procedural complications
Muscle strain
|
5.3%
1/19 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Investigations
Heart rate increased
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
4.5%
1/22 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Nervous system disorders
Hypoasthesia
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Nervous system disorders
Tremor
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Psychiatric disorders
Hypnagogic hallucination
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
4.5%
1/22 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
4.5%
1/22 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Reproductive system and breast disorders
Erection increased
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
4.5%
1/22 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
4.5%
1/22 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
4.5%
1/22 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 2 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Vascular disorders
Hypertension
|
5.3%
1/19 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/19 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/22 • From first dose of study drug through the follow-up (up to 38 days total)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through the follow-up (up to 38 days total)
|
0.00%
0/20 • From first dose of study drug through the follow-up (up to 38 days total)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60