Trial Outcomes & Findings for A Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Patients With Schizophrenia (NCT NCT01529515)
NCT ID: NCT01529515
Last Updated: 2016-05-11
Results Overview
Time to relapse defined as the time between participant randomization into the double blind Phase and the first documentation of a relapse event. Median time to relapse was estimated by the Kaplan-Meier method.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
509 participants
Primary outcome timeframe
Approximately Week 60
Results posted on
2016-05-11
Participant Flow
A total of 509 participants were enrolled in to the study and 506 participants were entered the Open-label Transition and received at least one dose of study drug (PP1M). 2 participants were enrolled but not received study drug and 1 participant was screen failure.
Participant milestones
| Measure |
Open-Label Transition Phase: Paliperidone Palmitate 1-Month
Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 150 milligram equivalents (mg eq) on Day 1, 100 mg eq on Day 8, flexible dose (50, 75, 100, or 150 mg eq) on Day 36 and 64, and on Day 92 same dose as on Day 64.
|
Open-Label Maintenance Phase: Paliperidone Palmitate 3-Month
Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 3.5-fold multiple of the PP1M dose received on Day 92 during the Transition Phase.
|
Double-Blind Phase: Placebo
Matching placebo \[20 percent (%) Intralipid solution\] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
|
Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
|
|---|---|---|---|---|
|
TRANSITION PHASE
STARTED
|
506
|
0
|
0
|
0
|
|
TRANSITION PHASE
COMPLETED
|
379
|
0
|
0
|
0
|
|
TRANSITION PHASE
NOT COMPLETED
|
127
|
0
|
0
|
0
|
|
MAINTENANCE PHASE
STARTED
|
0
|
379
|
0
|
0
|
|
MAINTENANCE PHASE
COMPLETED
|
0
|
305
|
0
|
0
|
|
MAINTENANCE PHASE
NOT COMPLETED
|
0
|
74
|
0
|
0
|
|
DOUBLE BLIND PHASE
STARTED
|
0
|
0
|
145
|
160
|
|
DOUBLE BLIND PHASE
COMPLETED
|
0
|
0
|
122
|
148
|
|
DOUBLE BLIND PHASE
NOT COMPLETED
|
0
|
0
|
23
|
12
|
Reasons for withdrawal
| Measure |
Open-Label Transition Phase: Paliperidone Palmitate 1-Month
Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 150 milligram equivalents (mg eq) on Day 1, 100 mg eq on Day 8, flexible dose (50, 75, 100, or 150 mg eq) on Day 36 and 64, and on Day 92 same dose as on Day 64.
|
Open-Label Maintenance Phase: Paliperidone Palmitate 3-Month
Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 3.5-fold multiple of the PP1M dose received on Day 92 during the Transition Phase.
|
Double-Blind Phase: Placebo
Matching placebo \[20 percent (%) Intralipid solution\] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
|
Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
|
|---|---|---|---|---|
|
TRANSITION PHASE
Adverse Event
|
16
|
0
|
0
|
0
|
|
TRANSITION PHASE
Death
|
1
|
0
|
0
|
0
|
|
TRANSITION PHASE
Lack of Efficacy
|
19
|
0
|
0
|
0
|
|
TRANSITION PHASE
Lost to Follow-up
|
19
|
0
|
0
|
0
|
|
TRANSITION PHASE
Protocol Violation
|
4
|
0
|
0
|
0
|
|
TRANSITION PHASE
Withdrawal by Subject
|
51
|
0
|
0
|
0
|
|
TRANSITION PHASE
Failed Maintenance Phase Criteria
|
8
|
0
|
0
|
0
|
|
TRANSITION PHASE
Other
|
9
|
0
|
0
|
0
|
|
MAINTENANCE PHASE
Adverse Event
|
0
|
10
|
0
|
0
|
|
MAINTENANCE PHASE
Lack of Efficacy
|
0
|
9
|
0
|
0
|
|
MAINTENANCE PHASE
Lost to Follow-up
|
0
|
5
|
0
|
0
|
|
MAINTENANCE PHASE
Protocol Violation
|
0
|
12
|
0
|
0
|
|
MAINTENANCE PHASE
Withdrawal by Subject
|
0
|
15
|
0
|
0
|
|
MAINTENANCE PHASE
Failed Randomization Criteria
|
0
|
13
|
0
|
0
|
|
MAINTENANCE PHASE
Other
|
0
|
10
|
0
|
0
|
|
DOUBLE BLIND PHASE
Adverse Event
|
0
|
0
|
1
|
0
|
|
DOUBLE BLIND PHASE
Lost to Follow-up
|
0
|
0
|
1
|
3
|
|
DOUBLE BLIND PHASE
Pregnancy
|
0
|
0
|
1
|
0
|
|
DOUBLE BLIND PHASE
Withdrawal by Subject
|
0
|
0
|
10
|
7
|
|
DOUBLE BLIND PHASE
Protocol Violation
|
0
|
0
|
1
|
0
|
|
DOUBLE BLIND PHASE
Other
|
0
|
0
|
9
|
2
|
Baseline Characteristics
A Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
Double-Blind Phase: Placebo
n=145 Participants
Matching placebo \[20 percent (%) Intralipid solution\] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
|
Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
n=160 Participants
Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
|
Total
n=305 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.5 years
STANDARD_DEVIATION 11.16 • n=5 Participants
|
37.1 years
STANDARD_DEVIATION 10.87 • n=7 Participants
|
37.8 years
STANDARD_DEVIATION 11.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
|
Region of Enrollment
Colombia
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Region of Enrollment
Malaysia
|
11 participants
n=5 Participants
|
12 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
10 participants
n=5 Participants
|
8 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
63 participants
n=5 Participants
|
74 participants
n=7 Participants
|
137 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
32 participants
n=7 Participants
|
58 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately Week 60Population: The intent-to-treat (ITT) double blind (DB) population included all participants who were randomly assigned to treatment during the Double-blind Phase and received at least one dose of Double-blind study agent.
Time to relapse defined as the time between participant randomization into the double blind Phase and the first documentation of a relapse event. Median time to relapse was estimated by the Kaplan-Meier method.
Outcome measures
| Measure |
Double-Blind Phase: Placebo
n=145 Participants
Matching placebo \[20 percent (%) Intralipid solution\] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
|
Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
n=160 Participants
Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
|
|---|---|---|
|
Time to Relapse During the Double-Blind Phase
|
395.0 Days
Interval 274.0 to
The NA in the context of the upper limit of a 95% Confidence Interval means "infinity".
|
NA Days
Median time to relapse could not be estimated due to insufficient number of relapses observed in this treatment group.
|
SECONDARY outcome
Timeframe: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)Population: Intent-to-treat (ITT) double blind (DB) population included all participants who were randomly assigned to treatment during DB Phase and received at least 1 dose of DB study agent. Missing data was imputed using LOCF method. Here "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.
The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items). Each item is rated 1 (absent) to 7 (extreme). The total score ranging from 30 to 210. Higher scores indicate more severe neuropsychiatric symptoms of schizophrenia.
Outcome measures
| Measure |
Double-Blind Phase: Placebo
n=142 Participants
Matching placebo \[20 percent (%) Intralipid solution\] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
|
Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
n=159 Participants
Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
|
|---|---|---|
|
Change in Positive and Negative Syndrome Scale (PANSS) (Total Score) From Baseline to Endpoint in the Double-Blind Phase
Baseline
|
54.3 Units on a Scale
Standard Deviation 9.20
|
54.8 Units on a Scale
Standard Deviation 9.96
|
|
Change in Positive and Negative Syndrome Scale (PANSS) (Total Score) From Baseline to Endpoint in the Double-Blind Phase
Change at Endpoint (Approximately Week 60)
|
6.7 Units on a Scale
Standard Deviation 14.40
|
-0.5 Units on a Scale
Standard Deviation 8.36
|
SECONDARY outcome
Timeframe: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)Population: Intent-to-treat (ITT) double blind (DB) population included all participants who were randomly assigned to treatment during DB Phase and received at least 1 dose of DB study agent. Missing data was imputed using LOCF method. Here "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.
The CGI-S rating scale is used to rate the severity of a participant's overall clinical condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe).
Outcome measures
| Measure |
Double-Blind Phase: Placebo
n=142 Participants
Matching placebo \[20 percent (%) Intralipid solution\] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
|
Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
n=159 Participants
Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
|
|---|---|---|
|
Change in Clinical Global Impression Severity (CGI-S) Scale From Baseline to Endpoint in the Double-Blind Phase
Baseline
|
2.8 Units on a Scale
Standard Deviation 0.65
|
2.7 Units on a Scale
Standard Deviation 0.68
|
|
Change in Clinical Global Impression Severity (CGI-S) Scale From Baseline to Endpoint in the Double-Blind Phase
Change at Endpoint (Approximately Week 60)
|
0.4 Units on a Scale
Standard Deviation 0.87
|
0.1 Units on a Scale
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)Population: Intent-to-treat (ITT) double blind (DB) population included all participants who were randomly assigned to treatment during DB Phase and received at least 1 dose of DB study agent. Missing data was imputed using LOCF method. Here "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.
The PSP scale measures personal and social functioning in the domains of: a) Socially useful activities, b) Personal and social relationships, c) Self-care, and d) Disturbing and aggressive behavior. The results of the assessment were converted to a numerical score which ranges from 1 to 100. A score lying between 71 and 100 indicates a mild degree of dysfunction; scores between 31 and 70 indicate varying degrees of difficulty, and a participant with a score of \<=30 had functioning so poor that he or she required intensive supervision.
Outcome measures
| Measure |
Double-Blind Phase: Placebo
n=142 Participants
Matching placebo \[20 percent (%) Intralipid solution\] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
|
Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
n=157 Participants
Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
|
|---|---|---|
|
Change in Personal and Social Performance (PSP) Scale From Baseline to Endpoint in the Double-Blind Phase
Change at Endpoint (Approximately Week 60)
|
-4.2 Units on a Scale
Standard Deviation 9.70
|
-0.5 Units on a Scale
Standard Deviation 6.63
|
|
Change in Personal and Social Performance (PSP) Scale From Baseline to Endpoint in the Double-Blind Phase
Baseline
|
68.5 Units on a Scale
Standard Deviation 8.93
|
68.9 Units on a Scale
Standard Deviation 9.34
|
Adverse Events
Open-Label Phase: PP1M + PP3M
Serious events: 33 serious events
Other events: 317 other events
Deaths: 0 deaths
Double-Blind Phase: Placebo
Serious events: 15 serious events
Other events: 77 other events
Deaths: 0 deaths
Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
Serious events: 4 serious events
Other events: 98 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open-Label Phase: PP1M + PP3M
n=506 participants at risk
PP1M= Paliperidone Palmitate 1 Month and PP3M= Paliperidone Palmitate 3 Month. Open-Label Transition Phase: Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 150 milligram equivalents (mg eq) on Day 1, 100 mg eq on Day 8, flexible dose (50, 75, 100, or 150 mg eq) on Day 36 and 64, and on Day 92 same dose as on Day 64. Open-Label Maintenance Phase: Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 3.5-fold multiple of the PP1M dose received on Day 92 during the Transition Phase.
|
Double-Blind Phase: Placebo
n=145 participants at risk
Matching placebo \[20 percent (%) Intralipid solution\] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
|
Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
n=160 participants at risk
Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastritis Erosive
|
0.20%
1/506 • Up to Week 92
|
0.00%
0/145 • Up to Week 92
|
0.00%
0/160 • Up to Week 92
|
|
Gastrointestinal disorders
Megacolon
|
0.20%
1/506 • Up to Week 92
|
0.00%
0/145 • Up to Week 92
|
0.00%
0/160 • Up to Week 92
|
|
Infections and infestations
Cellulitis
|
0.00%
0/506 • Up to Week 92
|
0.69%
1/145 • Up to Week 92
|
0.00%
0/160 • Up to Week 92
|
|
Infections and infestations
Pyelonephritis Chronic
|
0.20%
1/506 • Up to Week 92
|
0.00%
0/145 • Up to Week 92
|
0.00%
0/160 • Up to Week 92
|
|
Investigations
Transaminases Increased
|
0.00%
0/506 • Up to Week 92
|
0.69%
1/145 • Up to Week 92
|
0.00%
0/160 • Up to Week 92
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.20%
1/506 • Up to Week 92
|
0.00%
0/145 • Up to Week 92
|
0.00%
0/160 • Up to Week 92
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.20%
1/506 • Up to Week 92
|
0.00%
0/145 • Up to Week 92
|
0.00%
0/160 • Up to Week 92
|
|
Nervous system disorders
Syncope
|
0.20%
1/506 • Up to Week 92
|
0.00%
0/145 • Up to Week 92
|
0.00%
0/160 • Up to Week 92
|
|
Psychiatric disorders
Anxiety
|
0.20%
1/506 • Up to Week 92
|
0.69%
1/145 • Up to Week 92
|
0.00%
0/160 • Up to Week 92
|
|
Psychiatric disorders
Delusion
|
0.20%
1/506 • Up to Week 92
|
0.00%
0/145 • Up to Week 92
|
0.00%
0/160 • Up to Week 92
|
|
Psychiatric disorders
Depression
|
0.20%
1/506 • Up to Week 92
|
0.00%
0/145 • Up to Week 92
|
0.00%
0/160 • Up to Week 92
|
|
Psychiatric disorders
Hallucination, Auditory
|
0.40%
2/506 • Up to Week 92
|
0.00%
0/145 • Up to Week 92
|
0.00%
0/160 • Up to Week 92
|
|
Psychiatric disorders
Hallucination, Visual
|
0.20%
1/506 • Up to Week 92
|
0.00%
0/145 • Up to Week 92
|
0.00%
0/160 • Up to Week 92
|
|
Psychiatric disorders
Psychotic Disorder
|
1.8%
9/506 • Up to Week 92
|
0.00%
0/145 • Up to Week 92
|
0.00%
0/160 • Up to Week 92
|
|
Psychiatric disorders
Schizophrenia
|
2.4%
12/506 • Up to Week 92
|
7.6%
11/145 • Up to Week 92
|
0.62%
1/160 • Up to Week 92
|
|
Psychiatric disorders
Schizophrenia, Paranoid Type
|
0.20%
1/506 • Up to Week 92
|
0.00%
0/145 • Up to Week 92
|
0.62%
1/160 • Up to Week 92
|
|
Psychiatric disorders
Substance-Induced Psychotic Disorder
|
0.20%
1/506 • Up to Week 92
|
0.00%
0/145 • Up to Week 92
|
0.00%
0/160 • Up to Week 92
|
|
Psychiatric disorders
Suicidal Ideation
|
0.40%
2/506 • Up to Week 92
|
0.69%
1/145 • Up to Week 92
|
0.00%
0/160 • Up to Week 92
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/506 • Up to Week 92
|
0.00%
0/145 • Up to Week 92
|
1.2%
2/160 • Up to Week 92
|
|
Renal and urinary disorders
Calculus Urinary
|
0.20%
1/506 • Up to Week 92
|
0.00%
0/145 • Up to Week 92
|
0.00%
0/160 • Up to Week 92
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.20%
1/506 • Up to Week 92
|
0.00%
0/145 • Up to Week 92
|
0.00%
0/160 • Up to Week 92
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.20%
1/506 • Up to Week 92
|
0.00%
0/145 • Up to Week 92
|
0.00%
0/160 • Up to Week 92
|
|
Vascular disorders
Venous Thrombosis Limb
|
0.20%
1/506 • Up to Week 92
|
0.00%
0/145 • Up to Week 92
|
0.00%
0/160 • Up to Week 92
|
Other adverse events
| Measure |
Open-Label Phase: PP1M + PP3M
n=506 participants at risk
PP1M= Paliperidone Palmitate 1 Month and PP3M= Paliperidone Palmitate 3 Month. Open-Label Transition Phase: Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 150 milligram equivalents (mg eq) on Day 1, 100 mg eq on Day 8, flexible dose (50, 75, 100, or 150 mg eq) on Day 36 and 64, and on Day 92 same dose as on Day 64. Open-Label Maintenance Phase: Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 3.5-fold multiple of the PP1M dose received on Day 92 during the Transition Phase.
|
Double-Blind Phase: Placebo
n=145 participants at risk
Matching placebo \[20 percent (%) Intralipid solution\] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
|
Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
n=160 participants at risk
Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
|
|---|---|---|---|
|
General disorders
Injection Site Pain
|
8.7%
44/506 • Up to Week 92
|
0.00%
0/145 • Up to Week 92
|
1.2%
2/160 • Up to Week 92
|
|
Infections and infestations
Nasopharyngitis
|
2.8%
14/506 • Up to Week 92
|
1.4%
2/145 • Up to Week 92
|
5.6%
9/160 • Up to Week 92
|
|
Investigations
Weight Decreased
|
1.6%
8/506 • Up to Week 92
|
7.6%
11/145 • Up to Week 92
|
1.2%
2/160 • Up to Week 92
|
|
Investigations
Weight Increased
|
10.1%
51/506 • Up to Week 92
|
3.4%
5/145 • Up to Week 92
|
8.8%
14/160 • Up to Week 92
|
|
Nervous system disorders
Headache
|
6.5%
33/506 • Up to Week 92
|
4.1%
6/145 • Up to Week 92
|
8.8%
14/160 • Up to Week 92
|
|
Psychiatric disorders
Anxiety
|
8.5%
43/506 • Up to Week 92
|
10.3%
15/145 • Up to Week 92
|
8.1%
13/160 • Up to Week 92
|
|
Psychiatric disorders
Insomnia
|
9.9%
50/506 • Up to Week 92
|
11.7%
17/145 • Up to Week 92
|
6.9%
11/160 • Up to Week 92
|
|
Psychiatric disorders
Schizophrenia
|
0.79%
4/506 • Up to Week 92
|
5.5%
8/145 • Up to Week 92
|
0.62%
1/160 • Up to Week 92
|
|
Gastrointestinal disorders
Nausea
|
2.2%
11/506 • Up to Week 92
|
0.00%
0/145 • Up to Week 92
|
1.2%
2/160 • Up to Week 92
|
|
General disorders
Fatigue
|
2.6%
13/506 • Up to Week 92
|
0.00%
0/145 • Up to Week 92
|
1.2%
2/160 • Up to Week 92
|
|
General disorders
Injection Site Swelling
|
2.2%
11/506 • Up to Week 92
|
0.00%
0/145 • Up to Week 92
|
0.62%
1/160 • Up to Week 92
|
|
General disorders
Irritability
|
1.2%
6/506 • Up to Week 92
|
2.1%
3/145 • Up to Week 92
|
0.62%
1/160 • Up to Week 92
|
|
Infections and infestations
Influenza
|
0.99%
5/506 • Up to Week 92
|
2.1%
3/145 • Up to Week 92
|
1.9%
3/160 • Up to Week 92
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.8%
9/506 • Up to Week 92
|
2.1%
3/145 • Up to Week 92
|
3.8%
6/160 • Up to Week 92
|
|
Infections and infestations
Urinary Tract Infection
|
0.40%
2/506 • Up to Week 92
|
1.4%
2/145 • Up to Week 92
|
3.1%
5/160 • Up to Week 92
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/506 • Up to Week 92
|
2.1%
3/145 • Up to Week 92
|
1.9%
3/160 • Up to Week 92
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/506 • Up to Week 92
|
2.1%
3/145 • Up to Week 92
|
0.62%
1/160 • Up to Week 92
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/506 • Up to Week 92
|
2.8%
4/145 • Up to Week 92
|
0.00%
0/160 • Up to Week 92
|
|
Nervous system disorders
Akathisia
|
3.4%
17/506 • Up to Week 92
|
0.69%
1/145 • Up to Week 92
|
4.4%
7/160 • Up to Week 92
|
|
Nervous system disorders
Somnolence
|
3.0%
15/506 • Up to Week 92
|
0.00%
0/145 • Up to Week 92
|
0.62%
1/160 • Up to Week 92
|
|
Nervous system disorders
Tremor
|
2.4%
12/506 • Up to Week 92
|
0.00%
0/145 • Up to Week 92
|
1.2%
2/160 • Up to Week 92
|
|
Psychiatric disorders
Agitation
|
1.6%
8/506 • Up to Week 92
|
2.1%
3/145 • Up to Week 92
|
1.2%
2/160 • Up to Week 92
|
|
Psychiatric disorders
Suicidal Ideation
|
2.6%
13/506 • Up to Week 92
|
2.1%
3/145 • Up to Week 92
|
0.00%
0/160 • Up to Week 92
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.59%
3/506 • Up to Week 92
|
2.1%
3/145 • Up to Week 92
|
3.1%
5/160 • Up to Week 92
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. if requested in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER