Trial Outcomes & Findings for A Pharmacokinetic and Safety Study of Paliperidone Palmitate (JNS010) in Participants With Schizophrenia (NCT NCT01606254)
NCT ID: NCT01606254
Last Updated: 2013-06-05
Results Overview
The pre-dose plasma concentration (Cpredose) at Day 8 is defined as the plasma concentration obtained before a dose is given on Day 8. The mean Cpredose at Day 8 was measured in nanogram per milliliter (ng/ml).
COMPLETED
PHASE2
56 participants
Day 8
2013-06-05
Participant Flow
Participant milestones
| Measure |
Paliperidone Palmitate 50 mg
Paliperidone palmitate (JNS010) 50 milligram (mg) intramuscular (into the muscle) injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 100 mg
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150 mg
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150/ 50 mg
Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
|
|---|---|---|---|---|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
0
|
3
|
|
Overall Study
STARTED
|
14
|
14
|
14
|
14
|
|
Overall Study
COMPLETED
|
12
|
10
|
14
|
11
|
Reasons for withdrawal
| Measure |
Paliperidone Palmitate 50 mg
Paliperidone palmitate (JNS010) 50 milligram (mg) intramuscular (into the muscle) injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 100 mg
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150 mg
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150/ 50 mg
Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
0
|
2
|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
1
|
Baseline Characteristics
A Pharmacokinetic and Safety Study of Paliperidone Palmitate (JNS010) in Participants With Schizophrenia
Baseline characteristics by cohort
| Measure |
Paliperidone Palmitate 50 mg
n=14 Participants
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 100 mg
n=14 Participants
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150 mg
n=14 Participants
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150/ 50 mg
n=14 Participants
Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
46.4 Years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
45.2 Years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
48.7 Years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
49.4 Years
STANDARD_DEVIATION 12.1 • n=4 Participants
|
47.4 Years
STANDARD_DEVIATION 12.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Number of Participants with Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score
None
|
8 Participant
n=5 Participants
|
8 Participant
n=7 Participants
|
5 Participant
n=5 Participants
|
5 Participant
n=4 Participants
|
26 Participant
n=21 Participants
|
|
Number of Participants with Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score
Very mild
|
6 Participant
n=5 Participants
|
6 Participant
n=7 Participants
|
8 Participant
n=5 Participants
|
9 Participant
n=4 Participants
|
29 Participant
n=21 Participants
|
|
Number of Participants with Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score
Mild
|
0 Participant
n=5 Participants
|
0 Participant
n=7 Participants
|
1 Participant
n=5 Participants
|
0 Participant
n=4 Participants
|
1 Participant
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 8Population: Pharmacokinetic analysis set included all participants who received the study treatment and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
The pre-dose plasma concentration (Cpredose) at Day 8 is defined as the plasma concentration obtained before a dose is given on Day 8. The mean Cpredose at Day 8 was measured in nanogram per milliliter (ng/ml).
Outcome measures
| Measure |
Paliperidone Palmitate 50 mg
n=14 Participants
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 100 mg
n=14 Participants
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150 mg
n=13 Participants
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150/ 50 mg
n=14 Participants
Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
|
|---|---|---|---|---|
|
Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 8
|
5.85 ng/ml
Standard Deviation 4.47
|
7.28 ng/ml
Standard Deviation 4.92
|
28.4 ng/ml
Standard Deviation 29.2
|
12.1 ng/ml
Standard Deviation 7.46
|
PRIMARY outcome
Timeframe: Day 36Population: Pharmacokinetic analysis set included all participants who received the study treatment and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
The Cpredose at Day 36 is defined as the plasma concentration obtained before a dose is given on Day 36. The mean Cpredose at Day 36 was measured in ng/ml.
Outcome measures
| Measure |
Paliperidone Palmitate 50 mg
n=14 Participants
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 100 mg
n=12 Participants
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150 mg
n=14 Participants
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150/ 50 mg
n=12 Participants
Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
|
|---|---|---|---|---|
|
Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 36
|
6.77 ng/ml
Standard Deviation 3.75
|
14.5 ng/ml
Standard Deviation 5.76
|
23.4 ng/ml
Standard Deviation 18.6
|
19.5 ng/ml
Standard Deviation 16.1
|
PRIMARY outcome
Timeframe: Day 64Population: Pharmacokinetic analysis set included all participants who received the study treatment and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
The Cpredose at Day 64 is defined as the plasma paliperidone concentration obtained before a dose is given on Day 64. The mean Cpredose at Day 64 was measured in ng/ml.
Outcome measures
| Measure |
Paliperidone Palmitate 50 mg
n=13 Participants
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 100 mg
n=12 Participants
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150 mg
n=14 Participants
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150/ 50 mg
n=11 Participants
Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
|
|---|---|---|---|---|
|
Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 64
|
6.86 ng/ml
Standard Deviation 3.31
|
15.1 ng/ml
Standard Deviation 9.16
|
22.9 ng/ml
Standard Deviation 16.3
|
14.3 ng/ml
Standard Deviation 9.01
|
PRIMARY outcome
Timeframe: Day 92Population: Pharmacokinetic analysis set included all participants who received the study treatment and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
The Cpredose at Day 92 is defined as the plasma paliperidone concentration obtained after the treatment interval of the study drug (that is 4 weeks) passed after the final dose (Day 92). The mean Cpredose at Day 92 was measured in ng/ml.
Outcome measures
| Measure |
Paliperidone Palmitate 50 mg
n=13 Participants
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 100 mg
n=12 Participants
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150 mg
n=14 Participants
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150/ 50 mg
n=11 Participants
Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
|
|---|---|---|---|---|
|
Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 92
|
8.41 ng/ml
Standard Deviation 4.51
|
15.2 ng/ml
Standard Deviation 6.21
|
25.4 ng/ml
Standard Deviation 16.8
|
13.5 ng/ml
Standard Deviation 6.38
|
PRIMARY outcome
Timeframe: Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawalPopulation: Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
The Cmax is defined as maximum observed analyte concentration.
Outcome measures
| Measure |
Paliperidone Palmitate 50 mg
n=13 Participants
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 100 mg
n=12 Participants
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150 mg
n=14 Participants
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150/ 50 mg
n=11 Participants
Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Paliperidone
|
13.7 ng/ml
Standard Deviation 7.52
|
33.5 ng/ml
Standard Deviation 19.8
|
43.1 ng/ml
Standard Deviation 30.3
|
21.6 ng/ml
Standard Deviation 12.9
|
PRIMARY outcome
Timeframe: Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawalPopulation: Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Outcome measures
| Measure |
Paliperidone Palmitate 50 mg
n=13 Participants
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 100 mg
n=12 Participants
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150 mg
n=14 Participants
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150/ 50 mg
n=11 Participants
Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
|
|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Paliperidone
|
10.99 Days
Interval 1.99 to 21.01
|
7.89 Days
Interval 5.97 to 21.81
|
7.50 Days
Interval 2.93 to 27.01
|
3.82 Days
Interval 0.71 to 7.07
|
PRIMARY outcome
Timeframe: Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawalPopulation: Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
The AUCtau is a measure of the plasma paliperidone concentration from time zero to end of dosing interval. It is used to characterize drug absorption.
Outcome measures
| Measure |
Paliperidone Palmitate 50 mg
n=13 Participants
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 100 mg
n=12 Participants
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150 mg
n=14 Participants
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150/ 50 mg
n=11 Participants
Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
|
|---|---|---|---|---|
|
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
|
7081 nanogram*hour per milliliter
Standard Deviation 3581
|
15898 nanogram*hour per milliliter
Standard Deviation 7535
|
21853 nanogram*hour per milliliter
Standard Deviation 15534
|
11109 nanogram*hour per milliliter
Standard Deviation 5390
|
PRIMARY outcome
Timeframe: Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawalPopulation: Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
The Css av is defined as value of average analyte concentration at steady-state (after 4 Intramuscular Injections of Paliperidone Palmitate).
Outcome measures
| Measure |
Paliperidone Palmitate 50 mg
n=13 Participants
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 100 mg
n=12 Participants
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150 mg
n=14 Participants
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150/ 50 mg
n=11 Participants
Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
|
|---|---|---|---|---|
|
Plasma Paliperidone Concentration at Steady State (Css av)
|
10.7 ng/ml
Standard Deviation 5.42
|
23.9 ng/ml
Standard Deviation 11.4
|
32.8 ng/ml
Standard Deviation 23.1
|
16.7 ng/ml
Standard Deviation 8.28
|
PRIMARY outcome
Timeframe: Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawalPopulation: Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
Paliperidone Palmitate 50 mg
n=10 Participants
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 100 mg
n=10 Participants
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150 mg
n=9 Participants
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150/ 50 mg
n=11 Participants
Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
|
|---|---|---|---|---|
|
Paliperidone Plasma Decay Half-Life (t1/2)
|
68.1 Days
Standard Deviation 48.0
|
58.5 Days
Standard Deviation 29.1
|
95.5 Days
Standard Deviation 98.8
|
104.4 Days
Standard Deviation 97.1
|
PRIMARY outcome
Timeframe: Day 8Population: Safety analysis set included all participants who were enrolled in the study and received the study medication at least once.
The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).
Outcome measures
| Measure |
Paliperidone Palmitate 50 mg
n=14 Participants
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 100 mg
n=14 Participants
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150 mg
n=14 Participants
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150/ 50 mg
n=14 Participants
Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
|
|---|---|---|---|---|
|
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8
None
|
6 Participants
|
9 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8
Very mild
|
8 Participants
|
5 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8
Mild
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 22Population: Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).
Outcome measures
| Measure |
Paliperidone Palmitate 50 mg
n=14 Participants
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 100 mg
n=13 Participants
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150 mg
n=14 Participants
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150/ 50 mg
n=14 Participants
Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
|
|---|---|---|---|---|
|
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22
None
|
7 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22
Very mild
|
7 Participants
|
6 Participants
|
7 Participants
|
8 Participants
|
|
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22
Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 50Population: Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).
Outcome measures
| Measure |
Paliperidone Palmitate 50 mg
n=14 Participants
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 100 mg
n=12 Participants
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150 mg
n=14 Participants
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150/ 50 mg
n=12 Participants
Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
|
|---|---|---|---|---|
|
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50
None
|
11 Participants
|
7 Participants
|
8 Participants
|
6 Participants
|
|
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50
Very mild
|
3 Participants
|
5 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50
Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 78Population: Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).
Outcome measures
| Measure |
Paliperidone Palmitate 50 mg
n=13 Participants
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 100 mg
n=12 Participants
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150 mg
n=14 Participants
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150/ 50 mg
n=11 Participants
Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
|
|---|---|---|---|---|
|
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78
None
|
9 Participants
|
8 Participants
|
8 Participants
|
6 Participants
|
|
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78
Very mild
|
4 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78
Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 92Population: Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).
Outcome measures
| Measure |
Paliperidone Palmitate 50 mg
n=13 Participants
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 100 mg
n=12 Participants
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150 mg
n=14 Participants
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150/ 50 mg
n=11 Participants
Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
|
|---|---|---|---|---|
|
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92
None
|
7 Participants
|
7 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92
Very mild
|
6 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92
Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 120Population: Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).
Outcome measures
| Measure |
Paliperidone Palmitate 50 mg
n=13 Participants
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 100 mg
n=11 Participants
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150 mg
n=14 Participants
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150/ 50 mg
n=11 Participants
Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
|
|---|---|---|---|---|
|
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120
None
|
9 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120
Very mild
|
4 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
|
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120
Mild
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 162Population: Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).
Outcome measures
| Measure |
Paliperidone Palmitate 50 mg
n=12 Participants
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 100 mg
n=11 Participants
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150 mg
n=14 Participants
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150/ 50 mg
n=11 Participants
Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
|
|---|---|---|---|---|
|
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162
None
|
9 Participants
|
7 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162
Very mild
|
3 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162
Mild
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 218Population: Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).
Outcome measures
| Measure |
Paliperidone Palmitate 50 mg
n=12 Participants
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 100 mg
n=11 Participants
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150 mg
n=14 Participants
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150/ 50 mg
n=11 Participants
Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
|
|---|---|---|---|---|
|
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218
None
|
9 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218
Very mild
|
3 Participants
|
4 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218
Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 8, 22, 50, 78 and 92Population: Per protocol set (PPS) included all participants who were enrolled in the study, received study medication at least once and had at least one efficacy evaluation. Last observation carried forward (LOCF) imputation method was used. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group.
The PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).
Outcome measures
| Measure |
Paliperidone Palmitate 50 mg
n=14 Participants
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 100 mg
n=14 Participants
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150 mg
n=14 Participants
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150/ 50 mg
n=14 Participants
Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
|
|---|---|---|---|---|
|
Positive and Negative Syndrome Scale (PANSS) Total Score
Baseline (n = 14, 14, 14, 14)
|
61.9 units on a scale
Standard Deviation 12.39
|
60.7 units on a scale
Standard Deviation 17.28
|
60.4 units on a scale
Standard Deviation 16.76
|
63.9 units on a scale
Standard Deviation 15.58
|
|
Positive and Negative Syndrome Scale (PANSS) Total Score
Day 8 (n = 14, 14, 13, 14)
|
60.0 units on a scale
Standard Deviation 13.85
|
59.6 units on a scale
Standard Deviation 19.44
|
57.8 units on a scale
Standard Deviation 17.21
|
62.6 units on a scale
Standard Deviation 15.33
|
|
Positive and Negative Syndrome Scale (PANSS) Total Score
Day 22 (n = 14, 14, 14, 14)
|
56.8 units on a scale
Standard Deviation 13.19
|
58.1 units on a scale
Standard Deviation 19.59
|
57.1 units on a scale
Standard Deviation 16.10
|
60.4 units on a scale
Standard Deviation 13.15
|
|
Positive and Negative Syndrome Scale (PANSS) Total Score
Day 50 (n = 14, 14, 14, 14)
|
57.9 units on a scale
Standard Deviation 17.49
|
60.0 units on a scale
Standard Deviation 20.47
|
56.5 units on a scale
Standard Deviation 15.04
|
62.8 units on a scale
Standard Deviation 13.89
|
|
Positive and Negative Syndrome Scale (PANSS) Total Score
Day 78 (n = 14, 14, 14, 14)
|
56.4 units on a scale
Standard Deviation 17.07
|
60.4 units on a scale
Standard Deviation 20.05
|
57.2 units on a scale
Standard Deviation 18.55
|
59.9 units on a scale
Standard Deviation 13.03
|
|
Positive and Negative Syndrome Scale (PANSS) Total Score
Day 92 (n = 14, 14, 14, 14)
|
56.4 units on a scale
Standard Deviation 17.79
|
60.2 units on a scale
Standard Deviation 20.38
|
57.4 units on a scale
Standard Deviation 17.83
|
60.6 units on a scale
Standard Deviation 13.52
|
SECONDARY outcome
Timeframe: Baseline, Day 8, 22, 50, 78 and 92Population: The PPS included all participants who were enrolled in the study, received study medication at least once and had at least one efficacy evaluation. LOCF imputation method was used. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group.
The CGI-S rating scale is a 7 point (1-absent, 2-minimal, 3-mild, 4-moderate, 5-moderate severe, 6-severe, 7-extreme) global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "normal, not at all ill" and a rating of 7 is equivalent to "among the most extremely ill participants". Higher scores indicate worsening.
Outcome measures
| Measure |
Paliperidone Palmitate 50 mg
n=14 Participants
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 100 mg
n=14 Participants
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150 mg
n=14 Participants
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150/ 50 mg
n=14 Participants
Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
|
|---|---|---|---|---|
|
Number of Participants With Clinical Global Impression Severity (CGI-S) Score
Baseline, Minimal (n=14,14,14,14)
|
3 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Clinical Global Impression Severity (CGI-S) Score
Baseline, Mild (n=14,14,14,14)
|
8 Participants
|
6 Participants
|
10 Participants
|
8 Participants
|
|
Number of Participants With Clinical Global Impression Severity (CGI-S) Score
Baseline, Moderate (n=14,14,14,14)
|
3 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With Clinical Global Impression Severity (CGI-S) Score
Baseline, Moderate severe (n=14,14,14,14)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Global Impression Severity (CGI-S) Score
Day 8, Minimal (n=14,14,13,14)
|
3 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Clinical Global Impression Severity (CGI-S) Score
Day 8, Mild (n=14,14,13,14)
|
8 Participants
|
7 Participants
|
9 Participants
|
10 Participants
|
|
Number of Participants With Clinical Global Impression Severity (CGI-S) Score
Day 8, Moderate (n=14,14,13,14)
|
3 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Clinical Global Impression Severity (CGI-S) Score
Day 8, Moderate severe (n=14,14,13,14)
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Global Impression Severity (CGI-S) Score
Day 22, Minimal (n=14,14,14,14)
|
4 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Clinical Global Impression Severity (CGI-S) Score
Day 22, Mild (n=14,14,14,14)
|
8 Participants
|
5 Participants
|
9 Participants
|
9 Participants
|
|
Number of Participants With Clinical Global Impression Severity (CGI-S) Score
Day 22, Moderate (n=14,14,14,14)
|
2 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Clinical Global Impression Severity (CGI-S) Score
Day 22, Moderate severe (n=14,14,14,14)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Global Impression Severity (CGI-S) Score
Day 50, Minimal (n=14,14,14,14)
|
5 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Clinical Global Impression Severity (CGI-S) Score
Day 50, Mild (n=14,14,14,14)
|
7 Participants
|
4 Participants
|
10 Participants
|
13 Participants
|
|
Number of Participants With Clinical Global Impression Severity (CGI-S) Score
Day 50, Moderate (n=14,14,14,14)
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Global Impression Severity (CGI-S) Score
Day 50, Moderate severe (n=14,14,14,14)
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Global Impression Severity (CGI-S) Score
Day 78, Minimal (n=14,14,14,14)
|
6 Participants
|
5 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Clinical Global Impression Severity (CGI-S) Score
Day 78, Mild (n=14,14,14,14)
|
6 Participants
|
4 Participants
|
8 Participants
|
12 Participants
|
|
Number of Participants With Clinical Global Impression Severity (CGI-S) Score
Day 78, Moderate (n=14,14,14,14)
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Global Impression Severity (CGI-S) Score
Day 78, Moderate severe (n=14,14,14,14)
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Global Impression Severity (CGI-S) Score
Day 92, Minimal (n=14,14,14,14)
|
5 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Clinical Global Impression Severity (CGI-S) Score
Day 92, Mild(n=14,14,14,14)
|
7 Participants
|
5 Participants
|
8 Participants
|
11 Participants
|
|
Number of Participants With Clinical Global Impression Severity (CGI-S) Score
Day 92, Moderate (n=14,14,14,14)
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Clinical Global Impression Severity (CGI-S) Score
Day 92, Moderate severe (n=14,14,14,14)
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Paliperidone Palmitate 50 mg
Paliperidone Palmitate 100 mg
Paliperidone Palmitate 150 mg
Paliperidone Palmitate 150/ 50 mg
Serious adverse events
| Measure |
Paliperidone Palmitate 50 mg
n=14 participants at risk
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 100 mg
n=14 participants at risk
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150 mg
n=14 participants at risk
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150/ 50 mg
n=14 participants at risk
Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
|
|---|---|---|---|---|
|
Psychiatric disorders
Psychiatric symptom
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
14.3%
2/14 • Number of events 3
|
|
Psychiatric disorders
Schizophrenia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
|
Nervous system disorders
Convulsion
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14 • Number of events 2
|
0.00%
0/14
|
|
Nervous system disorders
Neuroleptic malignant syndrome
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
|
General disorders
Hypothermia
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
Other adverse events
| Measure |
Paliperidone Palmitate 50 mg
n=14 participants at risk
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 100 mg
n=14 participants at risk
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150 mg
n=14 participants at risk
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
|
Paliperidone Palmitate 150/ 50 mg
n=14 participants at risk
Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
7.1%
1/14
|
0.00%
0/14
|
7.1%
1/14
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Increased appetite
|
7.1%
1/14
|
0.00%
0/14
|
7.1%
1/14
|
7.1%
1/14
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Infections and infestations
Nasopharyngitis
|
35.7%
5/14
|
28.6%
4/14
|
28.6%
4/14
|
28.6%
4/14
|
|
Infections and infestations
Gastroenteritis
|
7.1%
1/14
|
0.00%
0/14
|
7.1%
1/14
|
7.1%
1/14
|
|
Infections and infestations
Pharyngitis
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
|
Infections and infestations
Bronchitis
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Infections and infestations
Folliculitis
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Infections and infestations
Otitis externa
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
|
Infections and infestations
Purulence
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.1%
1/14
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
Hyperphagia
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
|
Psychiatric disorders
Psychiatric symptom
|
35.7%
5/14
|
42.9%
6/14
|
21.4%
3/14
|
21.4%
3/14
|
|
Psychiatric disorders
Insomnia
|
21.4%
3/14
|
21.4%
3/14
|
28.6%
4/14
|
7.1%
1/14
|
|
Psychiatric disorders
Anxiety
|
14.3%
2/14
|
7.1%
1/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Psychiatric disorders
Hypochondriasis
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
7.1%
1/14
|
|
Psychiatric disorders
Abulia
|
7.1%
1/14
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Psychiatric disorders
Agitation
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Psychiatric disorders
Delusion
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Psychiatric disorders
Middle insomnia
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Nervous system disorders
Tremor
|
7.1%
1/14
|
7.1%
1/14
|
7.1%
1/14
|
14.3%
2/14
|
|
Nervous system disorders
Akathisia
|
0.00%
0/14
|
14.3%
2/14
|
0.00%
0/14
|
14.3%
2/14
|
|
Nervous system disorders
Headache
|
7.1%
1/14
|
7.1%
1/14
|
0.00%
0/14
|
14.3%
2/14
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
7.1%
1/14
|
|
Nervous system disorders
Dyskinesia
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
|
Nervous system disorders
Dystonia
|
0.00%
0/14
|
7.1%
1/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Nervous system disorders
Somnolence
|
7.1%
1/14
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Nervous system disorders
Delayed sleep phase
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Nervous system disorders
Hypersomnia
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Nervous system disorders
Migraine
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Nervous system disorders
Sedation
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
|
Nervous system disorders
Stupor
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
|
Eye disorders
Asthenopia
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Eye disorders
Blepharitis
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Cardiac disorders
Supraventricular extrasystoles
|
7.1%
1/14
|
7.1%
1/14
|
0.00%
0/14
|
7.1%
1/14
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
|
Cardiac disorders
Ventricular extrasystoles
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Vascular disorders
Hypertension
|
21.4%
3/14
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
7.1%
1/14
|
7.1%
1/14
|
14.3%
2/14
|
21.4%
3/14
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14
|
14.3%
2/14
|
14.3%
2/14
|
0.00%
0/14
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
14.3%
2/14
|
0.00%
0/14
|
14.3%
2/14
|
0.00%
0/14
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
1/14
|
7.1%
1/14
|
0.00%
0/14
|
7.1%
1/14
|
|
Gastrointestinal disorders
Stomach discomfort
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
7.1%
1/14
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14
|
14.3%
2/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Gastrointestinal disorders
Post-tussive vomiting
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
7.1%
1/14
|
7.1%
1/14
|
0.00%
0/14
|
14.3%
2/14
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Eczema
|
14.3%
2/14
|
14.3%
2/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/14
|
7.1%
1/14
|
7.1%
1/14
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14
|
0.00%
0/14
|
7.1%
1/14
|
21.4%
3/14
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
|
General disorders
Injection site pain
|
7.1%
1/14
|
7.1%
1/14
|
21.4%
3/14
|
14.3%
2/14
|
|
General disorders
Injection site erythema
|
7.1%
1/14
|
7.1%
1/14
|
14.3%
2/14
|
7.1%
1/14
|
|
General disorders
Injection site induration
|
14.3%
2/14
|
7.1%
1/14
|
14.3%
2/14
|
0.00%
0/14
|
|
General disorders
Thirst
|
0.00%
0/14
|
14.3%
2/14
|
0.00%
0/14
|
0.00%
0/14
|
|
General disorders
Injection site bruising
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
|
General disorders
Irritability
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
|
General disorders
Malaise
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
|
General disorders
Mass
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
|
General disorders
Pyrexia
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Investigations
Blood prolactin increased
|
78.6%
11/14
|
64.3%
9/14
|
92.9%
13/14
|
71.4%
10/14
|
|
Investigations
Weight increased
|
28.6%
4/14
|
14.3%
2/14
|
21.4%
3/14
|
14.3%
2/14
|
|
Investigations
Weight decreased
|
21.4%
3/14
|
21.4%
3/14
|
7.1%
1/14
|
14.3%
2/14
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
21.4%
3/14
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/14
|
0.00%
0/14
|
14.3%
2/14
|
14.3%
2/14
|
|
Investigations
White blood cell count increased
|
7.1%
1/14
|
0.00%
0/14
|
14.3%
2/14
|
7.1%
1/14
|
|
Investigations
Blood prolactin decreased
|
7.1%
1/14
|
7.1%
1/14
|
0.00%
0/14
|
7.1%
1/14
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
7.1%
1/14
|
|
Investigations
Blood pressure decreased
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
7.1%
1/14
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
|
Investigations
Protein urine present
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
|
Investigations
Blood alkaline phosphatase increased
|
7.1%
1/14
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Investigations
Blood albumin decreased
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
|
Investigations
Blood chloride decreased
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Investigations
Blood pressure increased
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Investigations
Blood sodium decreased
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Investigations
Blood triglycerides decreased
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
|
Investigations
Electrocardiogram ST segment depression
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
|
Investigations
Blood urine present
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Investigations
Protein total decreased
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
|
Investigations
Urine ketone body present
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
14.3%
2/14
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/14
|
7.1%
1/14
|
7.1%
1/14
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
Device breakage
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14
|
Additional Information
Medical Director
Janssen Pharm KK Japan
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place