Trial Outcomes & Findings for A Study to Evaluate the Efficacy, Safety and Tolerability of SEP-363856 in Subjects With Parkinson's Disease Psychosis (NCT NCT02969369)
NCT ID: NCT02969369
Last Updated: 2024-07-05
Results Overview
There are seven items assessing individual symptoms (four items for hallucinations and three items for delusions), a global hallucinations item and a global delusions item. Separate items are rated from 0 (absent) to 5 (severe), so that higher values represent a worse outcome. Total score is equal to the sum of the seven items plus the global hallucinations, plus the global delusions. Therefore a total possible score on the SAPS-PD ranges from 0 to 45. The primary analysis of the primary efficacy variable will use a mixed model for repeated measures (MMRM).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
SAPS-PD assessments during DB treatment period, Baseline and Week 6
Results posted on
2024-07-05
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo (QD)
|
SEP-363856
SEP-363856 (25, 50, or 75 mg/day flexible dosing QD)
|
|---|---|---|
|
Study
STARTED
|
14
|
25
|
|
Study
Modified Intent-to-Treat Population
|
14
|
24
|
|
Study
COMPLETED
|
10
|
11
|
|
Study
NOT COMPLETED
|
4
|
14
|
|
Double-blind Period
STARTED
|
14
|
25
|
|
Double-blind Period
Modified Intent-to-Treat Population
|
14
|
24
|
|
Double-blind Period
COMPLETED
|
11
|
15
|
|
Double-blind Period
NOT COMPLETED
|
3
|
10
|
|
Open-label SEP-363856 Period
STARTED
|
7
|
9
|
|
Open-label SEP-363856 Period
COMPLETED
|
6
|
5
|
|
Open-label SEP-363856 Period
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Placebo (QD)
|
SEP-363856
SEP-363856 (25, 50, or 75 mg/day flexible dosing QD)
|
|---|---|---|
|
Study
Adverse Event
|
1
|
6
|
|
Study
Lack of Efficacy
|
0
|
1
|
|
Study
Lost to Follow-up
|
0
|
1
|
|
Study
Withdrawal by Subject
|
3
|
5
|
|
Study
WITHDRAWAL BY PI DUE TO OTHER UNDERLYING ILLNESSES
|
0
|
1
|
|
Double-blind Period
Adverse Event
|
1
|
5
|
|
Double-blind Period
Lost to Follow-up
|
0
|
1
|
|
Double-blind Period
Withdrawal by Subject
|
2
|
3
|
|
Double-blind Period
WITHDRAWAL BY PI DUE TO OTHER UNDERLYING ILLNESSES
|
0
|
1
|
|
Open-label SEP-363856 Period
Adverse Event
|
0
|
1
|
|
Open-label SEP-363856 Period
Lack of Efficacy
|
0
|
1
|
|
Open-label SEP-363856 Period
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
One participant is missing this measurement in the data.
Baseline characteristics by cohort
| Measure |
Placebo
n=14 Participants
Placebo (QD)
|
SEP-363856
n=25 Participants
SEP-363856 (25, 50, or 75 mg/day flexible dosing QD)
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=14 Participants
|
5 Participants
n=25 Participants
|
7 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=14 Participants
|
20 Participants
n=25 Participants
|
32 Participants
n=39 Participants
|
|
Age, Continuous
|
71.8 Years
STANDARD_DEVIATION 7.12 • n=14 Participants
|
70.4 Years
STANDARD_DEVIATION 7.31 • n=25 Participants
|
70.9 Years
STANDARD_DEVIATION 7.18 • n=39 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=14 Participants
|
4 Participants
n=25 Participants
|
5 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=14 Participants
|
21 Participants
n=25 Participants
|
34 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=14 Participants
|
1 Participants
n=25 Participants
|
4 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=14 Participants
|
24 Participants
n=25 Participants
|
35 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 participants
n=14 Participants
|
0 participants
n=25 Participants
|
1 participants
n=39 Participants
|
|
Race/Ethnicity, Customized
White
|
12 participants
n=14 Participants
|
24 participants
n=25 Participants
|
36 participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=14 Participants
|
1 participants
n=25 Participants
|
1 participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=14 Participants
|
0 participants
n=25 Participants
|
1 participants
n=39 Participants
|
|
Age, Customized
>=55 - <65 years
|
2 Participants
n=14 Participants
|
5 Participants
n=25 Participants
|
7 Participants
n=39 Participants
|
|
Age, Customized
>=65 - <75 years
|
7 Participants
n=14 Participants
|
12 Participants
n=25 Participants
|
19 Participants
n=39 Participants
|
|
Age, Customized
>=75 years
|
5 Participants
n=14 Participants
|
8 Participants
n=25 Participants
|
13 Participants
n=39 Participants
|
|
Baseline Body Mass Index (BMI) (kg/m^2)
|
24.15 kg/m^2
STANDARD_DEVIATION 5.239 • n=13 Participants • One participant is missing this measurement in the data.
|
26.08 kg/m^2
STANDARD_DEVIATION 4.808 • n=25 Participants • One participant is missing this measurement in the data.
|
25.42 kg/m^2
STANDARD_DEVIATION 4.975 • n=38 Participants • One participant is missing this measurement in the data.
|
|
Baseline Body Mass Index (BMI) Category
<18.5 kg/m^2
|
1 Participants
n=14 Participants
|
1 Participants
n=25 Participants
|
2 Participants
n=39 Participants
|
|
Baseline Body Mass Index (BMI) Category
>=18.5 - <25.0 kg/m^2
|
7 Participants
n=14 Participants
|
8 Participants
n=25 Participants
|
15 Participants
n=39 Participants
|
|
Baseline Body Mass Index (BMI) Category
>=25.0 - <30.0 kg/m^2
|
3 Participants
n=14 Participants
|
14 Participants
n=25 Participants
|
17 Participants
n=39 Participants
|
|
Baseline Body Mass Index (BMI) Category
>=30.0 kg/m^2
|
2 Participants
n=14 Participants
|
2 Participants
n=25 Participants
|
4 Participants
n=39 Participants
|
|
Baseline Body Mass Index (BMI) Category
Missing
|
1 Participants
n=14 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=39 Participants
|
|
Baseline Scale for Assessment of Positive Symptoms - Parkinson's Disease (SAPS-PD) Total Score
|
14.7 Units on a scale
STANDARD_DEVIATION 8.71 • n=13 Participants • One participant is missing this measurement in the data.
|
13.3 Units on a scale
STANDARD_DEVIATION 6.00 • n=25 Participants • One participant is missing this measurement in the data.
|
13.8 Units on a scale
STANDARD_DEVIATION 6.96 • n=38 Participants • One participant is missing this measurement in the data.
|
|
Baseline Scale for Assessment of Positive Symptoms - Parkinson's Disease (SAPS-PD) Delusion Subscale
|
2.7 Units on a scale
STANDARD_DEVIATION 3.95 • n=13 Participants • One participant is missing this measurement in the data.
|
3.0 Units on a scale
STANDARD_DEVIATION 4.18 • n=25 Participants • One participant is missing this measurement in the data.
|
2.9 Units on a scale
STANDARD_DEVIATION 4.05 • n=38 Participants • One participant is missing this measurement in the data.
|
|
Baseline Scale for Assessment of Positive Symptoms - Parkinson's (SAPS-PD) Hallucination Subscale
|
12.0 Units on a scale
STANDARD_DEVIATION 6.60 • n=13 Participants • One participant is missing this measurement in the data.
|
10.3 Units on a scale
STANDARD_DEVIATION 4.54 • n=25 Participants • One participant is missing this measurement in the data.
|
10.9 Units on a scale
STANDARD_DEVIATION 5.31 • n=38 Participants • One participant is missing this measurement in the data.
|
PRIMARY outcome
Timeframe: SAPS-PD assessments during DB treatment period, Baseline and Week 6Population: The modified intention-to-treat (mITT) population is defined as all subjects who were randomized, received at least one dose of study drug, and had a baseline and at least one post-baseline total score in SAPS-PD or NPI or CGI-S during the DB treatment period. The mITT population is the primary population for the efficacy analyses. Subjects are analyzed according to randomized treatment group.
There are seven items assessing individual symptoms (four items for hallucinations and three items for delusions), a global hallucinations item and a global delusions item. Separate items are rated from 0 (absent) to 5 (severe), so that higher values represent a worse outcome. Total score is equal to the sum of the seven items plus the global hallucinations, plus the global delusions. Therefore a total possible score on the SAPS-PD ranges from 0 to 45. The primary analysis of the primary efficacy variable will use a mixed model for repeated measures (MMRM).
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo (QD)
|
SEP-363856
n=23 Participants
SEP-363856 (25, 50, or 75 mg/day flexible dosing QD)
|
|---|---|---|
|
Change From Double Blind (DB) Baseline in Total Scale for Assessment of Positive Symptoms - Parkinson's Disease ( SAPS-PD) Score at Week 6
|
-1.4 Units on a scale
Interval -5.6 to 2.8
|
-2.5 Units on a scale
Interval -5.8 to 0.8
|
SECONDARY outcome
Timeframe: CGI-S assessments during DB treatment period, Baseline and Week 6Population: The modified intention-to-treat (mITT) population is defined as all subjects who were randomized, received at least one dose of study drug, and had a baseline and at least one post-baseline total score in SAPS-PD or NPI or CGI-S during the DB treatment period. The mITT population is the primary population for the efficacy analyses. Subjects are analyzed according to randomized treatment group.
The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity. Analysis Method: Mixed Model Repeated Measures (MMRM)
Outcome measures
| Measure |
Placebo
n=14 Participants
Placebo (QD)
|
SEP-363856
n=20 Participants
SEP-363856 (25, 50, or 75 mg/day flexible dosing QD)
|
|---|---|---|
|
Change From Double Blind (DB) Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) at Week 6.
|
-0.7 Units on a scale
Interval -1.5 to 0.1
|
-0.4 Units on a scale
Interval -1.1 to 0.3
|
SECONDARY outcome
Timeframe: NPI assessments during DB treatment period, Baseline and Week 6Population: The modified intention-to-treat (mITT) population is defined as all subjects who were randomized, received at least one dose of study drug, and had a baseline and at least one post-baseline total score in SAPS-PD or NPI or CGI-S during the DB treatment period. The mITT population is the primary population for the efficacy analyses. Subjects are analyzed according to randomized treatment group.
The NPI is a 12-item behavior rating scale composed of a structured interview of the caregiver, which assesses psychiatric disturbance. For each subdomain, both the frequency (0 to 3 scale) and the severity (0 to 4 scale) of symptoms is determined. Higher scores represent a worse outcome. The subdomain score is the product of these two measures and ranges from 0 to 12. The combined NPI score is obtained by summing all 12 sub-domain scores and therefore ranges from 0 to 144. Analysis Method: Mixed Model Repeated Measures (MMRM)
Outcome measures
| Measure |
Placebo
n=14 Participants
Placebo (QD)
|
SEP-363856
n=23 Participants
SEP-363856 (25, 50, or 75 mg/day flexible dosing QD)
|
|---|---|---|
|
Change From Double Blind (DB) Baseline in Neuropsychiatric Inventory (NPI) at Week 6
|
-17.3 Units on a scale
Interval -28.3 to -6.2
|
-11.5 Units on a scale
Interval -20.2 to -2.8
|
SECONDARY outcome
Timeframe: MMSE assessments during DB treatment period, Baseline and Week 6Population: The modified intention-to-treat (mITT) population is defined as all subjects who were randomized, received at least one dose of study drug, and had a baseline and at least one post-baseline total score in SAPS-PD or NPI or CGI-S during the DB treatment period. The mITT population is the primary population for the efficacy analyses. Subjects are analyzed according to randomized treatment group.
The Mini Mental State Examination (MMSE) for Cognition is a brief instrument, used to assess cognitive function, consisting of 11 tests including orientation, memory (recent and immediate), concentration, language, and praxis. Scores range from 0 to 30, with lower scores indicating greater cognitive impairment. MMSE, the total score is the sum of all 11 tests. Analysis Method: Mixed Model Repeated Measures (MMRM)
Outcome measures
| Measure |
Placebo
n=14 Participants
Placebo (QD)
|
SEP-363856
n=23 Participants
SEP-363856 (25, 50, or 75 mg/day flexible dosing QD)
|
|---|---|---|
|
Change From Double-blind (DB) Baseline in Mini Mental State Evaluation (MMSE) at Week 6
|
0.3 Units on a scale
Interval -0.9 to 1.4
|
-0.8 Units on a scale
Interval -1.7 to 0.2
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
SEP-363856
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=14 participants at risk
Placebo (QD)
|
SEP-363856
n=32 participants at risk
SEP-363856 (25, 50, or 75 mg/day flexible dosing QD)
|
|---|---|---|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/14 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
3.1%
1/32 • Number of events 1 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/14 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
3.1%
1/32 • Number of events 1 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
Other adverse events
| Measure |
Placebo
n=14 participants at risk
Placebo (QD)
|
SEP-363856
n=32 participants at risk
SEP-363856 (25, 50, or 75 mg/day flexible dosing QD)
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
7.1%
1/14 • Number of events 2 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
0.00%
0/32 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
Cardiac disorders
Palpitations
|
7.1%
1/14 • Number of events 1 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
0.00%
0/32 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
7.1%
1/14 • Number of events 1 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
0.00%
0/32 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
1/14 • Number of events 1 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
0.00%
0/32 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 1 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
12.5%
4/32 • Number of events 4 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
General disorders
Asthenia
|
7.1%
1/14 • Number of events 1 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
3.1%
1/32 • Number of events 1 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
General disorders
Fatigue
|
14.3%
2/14 • Number of events 2 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
6.2%
2/32 • Number of events 2 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
General disorders
Pain
|
0.00%
0/14 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
6.2%
2/32 • Number of events 2 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • Number of events 1 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
6.2%
2/32 • Number of events 2 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
7.1%
1/14 • Number of events 1 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
3.1%
1/32 • Number of events 1 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
Injury, poisoning and procedural complications
Fall
|
21.4%
3/14 • Number of events 3 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
18.8%
6/32 • Number of events 9 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
Nervous system disorders
Balance disorder
|
7.1%
1/14 • Number of events 1 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
3.1%
1/32 • Number of events 1 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • Number of events 2 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
18.8%
6/32 • Number of events 10 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
Nervous system disorders
Lethargy
|
7.1%
1/14 • Number of events 1 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
0.00%
0/32 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
Nervous system disorders
Paraesthesia
|
7.1%
1/14 • Number of events 1 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
0.00%
0/32 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/14 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
9.4%
3/32 • Number of events 5 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/14 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
6.2%
2/32 • Number of events 2 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
Psychiatric disorders
Agitation
|
7.1%
1/14 • Number of events 1 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
6.2%
2/32 • Number of events 3 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/14 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
9.4%
3/32 • Number of events 3 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
Psychiatric disorders
Confusional state
|
14.3%
2/14 • Number of events 2 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
15.6%
5/32 • Number of events 5 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
Psychiatric disorders
Delusion
|
0.00%
0/14 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
9.4%
3/32 • Number of events 3 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
Psychiatric disorders
Depression
|
7.1%
1/14 • Number of events 1 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
0.00%
0/32 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
Psychiatric disorders
Disorientation
|
7.1%
1/14 • Number of events 1 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
0.00%
0/32 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
Psychiatric disorders
Hallucination
|
14.3%
2/14 • Number of events 2 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
21.9%
7/32 • Number of events 8 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
Psychiatric disorders
Hallucination, auditory
|
7.1%
1/14 • Number of events 1 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
0.00%
0/32 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
Psychiatric disorders
Insomnia
|
7.1%
1/14 • Number of events 1 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
9.4%
3/32 • Number of events 3 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
1/14 • Number of events 1 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
0.00%
0/32 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
Vascular disorders
Hypertension
|
14.3%
2/14 • Number of events 2 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
6.2%
2/32 • Number of events 3 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
Vascular disorders
Hypotension
|
0.00%
0/14 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
9.4%
3/32 • Number of events 6 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
|
Vascular disorders
Orthostatic hypotension
|
7.1%
1/14 • Number of events 1 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
0.00%
0/32 • All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
- Publication restrictions are in place
Restriction type: OTHER