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A Pharmacokinetic and Safety Study of Paliperidone Palmitate (JNS010) in Participants With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01606254
Recruitment Status : Completed
First Posted : May 25, 2012
Results First Posted : April 18, 2013
Last Update Posted : June 5, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: Paliperidone palmitate
Enrollment 56
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Paliperidone Palmitate 50 mg Paliperidone Palmitate 100 mg Paliperidone Palmitate 150 mg Paliperidone Palmitate 150/ 50 mg
Hide Arm/Group Description Paliperidone palmitate (JNS010) 50 milligram (mg) intramuscular (into the muscle) injection administered on Days 1, 8, 36 and 64. Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64. Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64. Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
Period Title: Overall Study
Started 14 14 14 14
Completed 12 10 14 11
Not Completed 2 4 0 3
Reason Not Completed
Withdrawal by Subject             1             3             0             2
Adverse Event             1             1             0             1
Arm/Group Title Paliperidone Palmitate 50 mg Paliperidone Palmitate 100 mg Paliperidone Palmitate 150 mg Paliperidone Palmitate 150/ 50 mg Total
Hide Arm/Group Description Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64. Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64. Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64. 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 of all reporting groups
Overall Number of Baseline Participants 14 14 14 14 56
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 14 participants 14 participants 14 participants 56 participants
46.4  (13.8) 45.2  (11.1) 48.7  (11.8) 49.4  (12.1) 47.4  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 14 participants 14 participants 56 participants
Female
2
  14.3%
5
  35.7%
3
  21.4%
6
  42.9%
16
  28.6%
Male
12
  85.7%
9
  64.3%
11
  78.6%
8
  57.1%
40
  71.4%
Number of Participants with Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score   [1] 
Measure Type: Number
Unit of measure:  Participant
Number Analyzed 14 participants 14 participants 14 participants 14 participants 56 participants
None 8 8 5 5 26
Very mild 6 6 8 9 29
Mild 0 0 1 0 1
[1]
Measure Description: Drug Induced Extra-Pyramidal Symptoms Scale (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]).
1.Primary Outcome
Title Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 8
Hide Description 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).
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Paliperidone Palmitate 50 mg Paliperidone Palmitate 100 mg Paliperidone Palmitate 150 mg Paliperidone Palmitate 150/ 50 mg
Hide Arm/Group Description:
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
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 Number of Participants Analyzed 14 14 13 14
Mean (Standard Deviation)
Unit of Measure: ng/ml
5.85  (4.47) 7.28  (4.92) 28.4  (29.2) 12.1  (7.46)
2.Primary Outcome
Title Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 36
Hide Description 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.
Time Frame Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Paliperidone Palmitate 50 mg Paliperidone Palmitate 100 mg Paliperidone Palmitate 150 mg Paliperidone Palmitate 150/ 50 mg
Hide Arm/Group Description:
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
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 Number of Participants Analyzed 14 12 14 12
Mean (Standard Deviation)
Unit of Measure: ng/ml
6.77  (3.75) 14.5  (5.76) 23.4  (18.6) 19.5  (16.1)
3.Primary Outcome
Title Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 64
Hide Description 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.
Time Frame Day 64
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Paliperidone Palmitate 50 mg Paliperidone Palmitate 100 mg Paliperidone Palmitate 150 mg Paliperidone Palmitate 150/ 50 mg
Hide Arm/Group Description:
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
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 Number of Participants Analyzed 13 12 14 11
Mean (Standard Deviation)
Unit of Measure: ng/ml
6.86  (3.31) 15.1  (9.16) 22.9  (16.3) 14.3  (9.01)
4.Primary Outcome
Title Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 92
Hide Description 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.
Time Frame Day 92
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Paliperidone Palmitate 50 mg Paliperidone Palmitate 100 mg Paliperidone Palmitate 150 mg Paliperidone Palmitate 150/ 50 mg
Hide Arm/Group Description:
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
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 Number of Participants Analyzed 13 12 14 11
Mean (Standard Deviation)
Unit of Measure: ng/ml
8.41  (4.51) 15.2  (6.21) 25.4  (16.8) 13.5  (6.38)
5.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Paliperidone
Hide Description The Cmax is defined as maximum observed analyte concentration.
Time Frame Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Paliperidone Palmitate 50 mg Paliperidone Palmitate 100 mg Paliperidone Palmitate 150 mg Paliperidone Palmitate 150/ 50 mg
Hide Arm/Group Description:
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
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 Number of Participants Analyzed 13 12 14 11
Mean (Standard Deviation)
Unit of Measure: ng/ml
13.7  (7.52) 33.5  (19.8) 43.1  (30.3) 21.6  (12.9)
6.Primary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) of Paliperidone
Hide Description The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Time Frame Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Paliperidone Palmitate 50 mg Paliperidone Palmitate 100 mg Paliperidone Palmitate 150 mg Paliperidone Palmitate 150/ 50 mg
Hide Arm/Group Description:
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
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 Number of Participants Analyzed 13 12 14 11
Median (Full Range)
Unit of Measure: Days
10.99
(1.99 to 21.01)
7.89
(5.97 to 21.81)
7.50
(2.93 to 27.01)
3.82
(0.71 to 7.07)
7.Primary Outcome
Title Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Hide Description 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.
Time Frame Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Paliperidone Palmitate 50 mg Paliperidone Palmitate 100 mg Paliperidone Palmitate 150 mg Paliperidone Palmitate 150/ 50 mg
Hide Arm/Group Description:
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
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 Number of Participants Analyzed 13 12 14 11
Mean (Standard Deviation)
Unit of Measure: nanogram*hour per milliliter
7081  (3581) 15898  (7535) 21853  (15534) 11109  (5390)
8.Primary Outcome
Title Plasma Paliperidone Concentration at Steady State (Css av)
Hide Description The Css av is defined as value of average analyte concentration at steady-state (after 4 Intramuscular Injections of Paliperidone Palmitate).
Time Frame Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Paliperidone Palmitate 50 mg Paliperidone Palmitate 100 mg Paliperidone Palmitate 150 mg Paliperidone Palmitate 150/ 50 mg
Hide Arm/Group Description:
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
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 Number of Participants Analyzed 13 12 14 11
Mean (Standard Deviation)
Unit of Measure: ng/ml
10.7  (5.42) 23.9  (11.4) 32.8  (23.1) 16.7  (8.28)
9.Primary Outcome
Title Paliperidone Plasma Decay Half-Life (t1/2)
Hide Description Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Paliperidone Palmitate 50 mg Paliperidone Palmitate 100 mg Paliperidone Palmitate 150 mg Paliperidone Palmitate 150/ 50 mg
Hide Arm/Group Description:
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
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 Number of Participants Analyzed 10 10 9 11
Mean (Standard Deviation)
Unit of Measure: Days
68.1  (48.0) 58.5  (29.1) 95.5  (98.8) 104.4  (97.1)
10.Primary Outcome
Title Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8
Hide Description 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]).
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled in the study and received the study medication at least once.
Arm/Group Title Paliperidone Palmitate 50 mg Paliperidone Palmitate 100 mg Paliperidone Palmitate 150 mg Paliperidone Palmitate 150/ 50 mg
Hide Arm/Group Description:
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
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 Number of Participants Analyzed 14 14 14 14
Measure Type: Number
Unit of Measure: Participants
None 6 9 6 6
Very mild 8 5 6 7
Mild 0 0 2 1
11.Primary Outcome
Title Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22
Hide Description 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]).
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Paliperidone Palmitate 50 mg Paliperidone Palmitate 100 mg Paliperidone Palmitate 150 mg Paliperidone Palmitate 150/ 50 mg
Hide Arm/Group Description:
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
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 Number of Participants Analyzed 14 13 14 14
Measure Type: Number
Unit of Measure: Participants
None 7 7 6 6
Very mild 7 6 7 8
Mild 0 0 1 0
12.Primary Outcome
Title Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50
Hide Description 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]).
Time Frame Day 50
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Paliperidone Palmitate 50 mg Paliperidone Palmitate 100 mg Paliperidone Palmitate 150 mg Paliperidone Palmitate 150/ 50 mg
Hide Arm/Group Description:
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
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 Number of Participants Analyzed 14 12 14 12
Measure Type: Number
Unit of Measure: Participants
None 11 7 8 6
Very mild 3 5 5 6
Mild 0 0 1 0
13.Primary Outcome
Title Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78
Hide Description 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]).
Time Frame Day 78
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Paliperidone Palmitate 50 mg Paliperidone Palmitate 100 mg Paliperidone Palmitate 150 mg Paliperidone Palmitate 150/ 50 mg
Hide Arm/Group Description:
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
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 Number of Participants Analyzed 13 12 14 11
Measure Type: Number
Unit of Measure: Participants
None 9 8 8 6
Very mild 4 4 5 5
Mild 0 0 1 0
14.Primary Outcome
Title Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92
Hide Description 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]).
Time Frame Day 92
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Paliperidone Palmitate 50 mg Paliperidone Palmitate 100 mg Paliperidone Palmitate 150 mg Paliperidone Palmitate 150/ 50 mg
Hide Arm/Group Description:
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
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 Number of Participants Analyzed 13 12 14 11
Measure Type: Number
Unit of Measure: Participants
None 7 7 7 5
Very mild 6 5 6 6
Mild 0 0 1 0
15.Primary Outcome
Title Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120
Hide Description 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]).
Time Frame Day 120
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Paliperidone Palmitate 50 mg Paliperidone Palmitate 100 mg Paliperidone Palmitate 150 mg Paliperidone Palmitate 150/ 50 mg
Hide Arm/Group Description:
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
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 Number of Participants Analyzed 13 11 14 11
Measure Type: Number
Unit of Measure: Participants
None 9 6 6 6
Very mild 4 5 6 5
Mild 0 0 2 0
16.Primary Outcome
Title Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162
Hide Description 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]).
Time Frame Day 162
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Paliperidone Palmitate 50 mg Paliperidone Palmitate 100 mg Paliperidone Palmitate 150 mg Paliperidone Palmitate 150/ 50 mg
Hide Arm/Group Description:
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
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 Number of Participants Analyzed 12 11 14 11
Measure Type: Number
Unit of Measure: Participants
None 9 7 6 7
Very mild 3 4 6 4
Mild 0 0 2 0
17.Primary Outcome
Title Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218
Hide Description 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]).
Time Frame Day 218
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Paliperidone Palmitate 50 mg Paliperidone Palmitate 100 mg Paliperidone Palmitate 150 mg Paliperidone Palmitate 150/ 50 mg
Hide Arm/Group Description:
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
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 Number of Participants Analyzed 12 11 14 11
Measure Type: Number
Unit of Measure: Participants
None 9 7 6 6
Very mild 3 4 7 5
Mild 0 0 1 0
18.Secondary Outcome
Title Positive and Negative Syndrome Scale (PANSS) Total Score
Hide Description 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).
Time Frame Baseline, Day 8, 22, 50, 78 and 92
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Paliperidone Palmitate 50 mg Paliperidone Palmitate 100 mg Paliperidone Palmitate 150 mg Paliperidone Palmitate 150/ 50 mg
Hide Arm/Group Description:
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
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 Number of Participants Analyzed 14 14 14 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n = 14, 14, 14, 14) 61.9  (12.39) 60.7  (17.28) 60.4  (16.76) 63.9  (15.58)
Day 8 (n = 14, 14, 13, 14) 60.0  (13.85) 59.6  (19.44) 57.8  (17.21) 62.6  (15.33)
Day 22 (n = 14, 14, 14, 14) 56.8  (13.19) 58.1  (19.59) 57.1  (16.10) 60.4  (13.15)
Day 50 (n = 14, 14, 14, 14) 57.9  (17.49) 60.0  (20.47) 56.5  (15.04) 62.8  (13.89)
Day 78 (n = 14, 14, 14, 14) 56.4  (17.07) 60.4  (20.05) 57.2  (18.55) 59.9  (13.03)
Day 92 (n = 14, 14, 14, 14) 56.4  (17.79) 60.2  (20.38) 57.4  (17.83) 60.6  (13.52)
19.Secondary Outcome
Title Number of Participants With Clinical Global Impression Severity (CGI-S) Score
Hide Description 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.
Time Frame Baseline, Day 8, 22, 50, 78 and 92
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Hide Analysis Population Description
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.
Arm/Group Title Paliperidone Palmitate 50 mg Paliperidone Palmitate 100 mg Paliperidone Palmitate 150 mg Paliperidone Palmitate 150/ 50 mg
Hide Arm/Group Description:
Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
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 Number of Participants Analyzed 14 14 14 14
Measure Type: Number
Unit of Measure: Participants
Baseline, Minimal (n=14,14,14,14) 3 4 3 1
Baseline, Mild (n=14,14,14,14) 8 6 10 8
Baseline, Moderate (n=14,14,14,14) 3 3 1 5
Baseline, Moderate severe (n=14,14,14,14) 0 1 0 0
Day 8, Minimal (n=14,14,13,14) 3 3 3 1
Day 8, Mild (n=14,14,13,14) 8 7 9 10
Day 8, Moderate (n=14,14,13,14) 3 2 1 3
Day 8, Moderate severe (n=14,14,13,14) 0 2 0 0
Day 22, Minimal (n=14,14,14,14) 4 5 4 2
Day 22, Mild (n=14,14,14,14) 8 5 9 9
Day 22, Moderate (n=14,14,14,14) 2 3 1 3
Day 22, Moderate severe (n=14,14,14,14) 0 1 0 0
Day 50, Minimal (n=14,14,14,14) 5 5 3 0
Day 50, Mild (n=14,14,14,14) 7 4 10 13
Day 50, Moderate (n=14,14,14,14) 1 3 1 0
Day 50, Moderate severe (n=14,14,14,14) 1 2 0 1
Day 78, Minimal (n=14,14,14,14) 6 5 5 1
Day 78, Mild (n=14,14,14,14) 6 4 8 12
Day 78, Moderate (n=14,14,14,14) 1 3 0 1
Day 78, Moderate severe (n=14,14,14,14) 1 2 1 0
Day 92, Minimal (n=14,14,14,14) 5 4 5 1
Day 92, Mild(n=14,14,14,14) 7 5 8 11
Day 92, Moderate (n=14,14,14,14) 1 3 0 2
Day 92, Moderate severe (n=14,14,14,14) 1 2 1 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paliperidone Palmitate 50 mg Paliperidone Palmitate 100 mg Paliperidone Palmitate 150 mg Paliperidone Palmitate 150/ 50 mg
Hide Arm/Group Description Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64. Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64. Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64. Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
All-Cause Mortality
Paliperidone Palmitate 50 mg Paliperidone Palmitate 100 mg Paliperidone Palmitate 150 mg Paliperidone Palmitate 150/ 50 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Paliperidone Palmitate 50 mg Paliperidone Palmitate 100 mg Paliperidone Palmitate 150 mg Paliperidone Palmitate 150/ 50 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/14 (7.14%)      0/14 (0.00%)      2/14 (14.29%)      3/14 (21.43%)    
General disorders         
Hypothermia * 1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0
Nervous system disorders         
Convulsion * 1  0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1
Grand mal convulsion * 1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  2 0/14 (0.00%)  0
Neuroleptic malignant syndrome * 1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0
Psychiatric disorders         
Psychiatric symptom * 1  0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 2/14 (14.29%)  3
Schizophrenia * 1  1/14 (7.14%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0
Suicide attempt * 1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Paliperidone Palmitate 50 mg Paliperidone Palmitate 100 mg Paliperidone Palmitate 150 mg Paliperidone Palmitate 150/ 50 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/14 (100.00%)      14/14 (100.00%)      14/14 (100.00%)      14/14 (100.00%)    
Cardiac disorders         
Supraventricular extrasystoles * 1  1/14 (7.14%)  1/14 (7.14%)  0/14 (0.00%)  1/14 (7.14%) 
Bradycardia * 1  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Sinus bradycardia * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Sinus tachycardia * 1  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Ventricular extrasystoles * 1  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Eye disorders         
Asthenopia * 1  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%) 
Blepharitis * 1  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Conjunctivitis * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Conjunctivitis allergic * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Ocular hyperaemia * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Gastrointestinal disorders         
Constipation * 1  1/14 (7.14%)  2/14 (14.29%)  2/14 (14.29%)  0/14 (0.00%) 
Salivary hypersecretion * 1  2/14 (14.29%)  0/14 (0.00%)  2/14 (14.29%)  0/14 (0.00%) 
Diarrhoea * 1  1/14 (7.14%)  1/14 (7.14%)  0/14 (0.00%)  1/14 (7.14%) 
Stomach discomfort * 1  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Toothache * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  1/14 (7.14%) 
Vomiting * 1  0/14 (0.00%)  2/14 (14.29%)  0/14 (0.00%)  0/14 (0.00%) 
Abdominal pain * 1  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Abdominal pain upper * 1  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%) 
Cheilitis * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Dental caries * 1  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Periodontitis * 1  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%) 
Stomatitis * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Gastrointestinal motility disorder * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Post-tussive vomiting * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
General disorders         
Injection site pain * 1  1/14 (7.14%)  1/14 (7.14%)  3/14 (21.43%)  2/14 (14.29%) 
Injection site erythema * 1  1/14 (7.14%)  1/14 (7.14%)  2/14 (14.29%)  1/14 (7.14%) 
Injection site induration * 1  2/14 (14.29%)  1/14 (7.14%)  2/14 (14.29%)  0/14 (0.00%) 
Thirst * 1  0/14 (0.00%)  2/14 (14.29%)  0/14 (0.00%)  0/14 (0.00%) 
Injection site bruising * 1  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%) 
Irritability * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Malaise * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Mass * 1  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%) 
Pyrexia * 1  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%) 
Hepatobiliary disorders         
Hepatic function abnormal * 1  1/14 (7.14%)  1/14 (7.14%)  0/14 (0.00%)  2/14 (14.29%) 
Hepatic steatosis * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Infections and infestations         
Nasopharyngitis * 1  5/14 (35.71%)  4/14 (28.57%)  4/14 (28.57%)  4/14 (28.57%) 
Gastroenteritis * 1  1/14 (7.14%)  0/14 (0.00%)  1/14 (7.14%)  1/14 (7.14%) 
Pharyngitis * 1  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Bronchitis * 1  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Folliculitis * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Otitis externa * 1  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Purulence * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Injury, poisoning and procedural complications         
Fall * 1  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  2/14 (14.29%) 
Contusion * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  1/14 (7.14%) 
Wound * 1  0/14 (0.00%)  1/14 (7.14%)  1/14 (7.14%)  0/14 (0.00%) 
Device breakage * 1  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Epicondylitis * 1  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%) 
Injury * 1  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%) 
Joint sprain * 1  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%) 
Muscle injury * 1  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Skin laceration * 1  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Investigations         
Blood prolactin increased * 1  11/14 (78.57%)  9/14 (64.29%)  13/14 (92.86%)  10/14 (71.43%) 
Weight increased * 1  4/14 (28.57%)  2/14 (14.29%)  3/14 (21.43%)  2/14 (14.29%) 
Weight decreased * 1  3/14 (21.43%)  3/14 (21.43%)  1/14 (7.14%)  2/14 (14.29%) 
Alanine aminotransferase increased * 1  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  3/14 (21.43%) 
Blood triglycerides increased * 1  0/14 (0.00%)  0/14 (0.00%)  2/14 (14.29%)  2/14 (14.29%) 
White blood cell count increased * 1  1/14 (7.14%)  0/14 (0.00%)  2/14 (14.29%)  1/14 (7.14%) 
Blood prolactin decreased * 1  1/14 (7.14%)  1/14 (7.14%)  0/14 (0.00%)  1/14 (7.14%) 
Blood creatine phosphokinase increased * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  1/14 (7.14%) 
Blood pressure decreased * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  1/14 (7.14%) 
Gamma-glutamyltransferase increased * 1  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Protein urine present * 1  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Blood alkaline phosphatase increased * 1  1/14 (7.14%)  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%) 
Blood albumin decreased * 1  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Blood chloride decreased * 1  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%) 
Blood cholesterol increased * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Blood pressure increased * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Blood sodium decreased * 1  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%) 
Blood triglycerides decreased * 1  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Electrocardiogram ST segment depression * 1  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Blood urine present * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Low density lipoprotein increased * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Protein total decreased * 1  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Urine ketone body present * 1  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Metabolism and nutrition disorders         
Anorexia * 1  1/14 (7.14%)  0/14 (0.00%)  1/14 (7.14%)  1/14 (7.14%) 
Increased appetite * 1  1/14 (7.14%)  0/14 (0.00%)  1/14 (7.14%)  1/14 (7.14%) 
Decreased appetite * 1  1/14 (7.14%)  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%) 
Hyperphagia * 1  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Musculoskeletal and connective tissue disorders         
Back pain * 1  1/14 (7.14%)  0/14 (0.00%)  1/14 (7.14%)  3/14 (21.43%) 
Neck pain * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  1/14 (7.14%) 
Pain in extremity * 1  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Arthralgia * 1  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Musculoskeletal pain * 1  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%) 
Osteoarthritis * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Spinal osteoarthritis * 1  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Musculoskeletal stiffness * 1  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%) 
Nervous system disorders         
Tremor * 1  1/14 (7.14%)  1/14 (7.14%)  1/14 (7.14%)  2/14 (14.29%) 
Akathisia * 1  0/14 (0.00%)  2/14 (14.29%)  0/14 (0.00%)  2/14 (14.29%) 
Headache * 1  1/14 (7.14%)  1/14 (7.14%)  0/14 (0.00%)  2/14 (14.29%) 
Dizziness * 1  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Dizziness postural * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  1/14 (7.14%) 
Dyskinesia * 1  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Dystonia * 1  0/14 (0.00%)  1/14 (7.14%)  1/14 (7.14%)  0/14 (0.00%) 
Somnolence * 1  1/14 (7.14%)  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Delayed sleep phase * 1  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Dysarthria * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Hypersomnia * 1  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Migraine * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Sedation * 1  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Stupor * 1  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%) 
Restless legs syndrome * 1  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Psychiatric disorders         
Psychiatric symptom * 1  5/14 (35.71%)  6/14 (42.86%)  3/14 (21.43%)  3/14 (21.43%) 
Insomnia * 1  3/14 (21.43%)  3/14 (21.43%)  4/14 (28.57%)  1/14 (7.14%) 
Anxiety * 1  2/14 (14.29%)  1/14 (7.14%)  1/14 (7.14%)  0/14 (0.00%) 
Hypochondriasis * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  1/14 (7.14%) 
Abulia * 1  1/14 (7.14%)  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Agitation * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Delusion * 1  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Hallucination, auditory * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Middle insomnia * 1  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Renal and urinary disorders         
Urinary incontinence * 1  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Renal impairment * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Reproductive system and breast disorders         
Dysmenorrhoea * 1  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Respiratory, thoracic and mediastinal disorders         
Upper respiratory tract inflammation * 1  1/14 (7.14%)  1/14 (7.14%)  2/14 (14.29%)  3/14 (21.43%) 
Cough * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Skin and subcutaneous tissue disorders         
Eczema * 1  2/14 (14.29%)  2/14 (14.29%)  1/14 (7.14%)  0/14 (0.00%) 
Dry skin * 1  0/14 (0.00%)  1/14 (7.14%)  1/14 (7.14%)  1/14 (7.14%) 
Rash * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  1/14 (7.14%) 
Dermatitis allergic * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Dermatitis atopic * 1  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Dermatitis contact * 1  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%) 
Heat rash * 1  1/14 (7.14%)  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Pruritus * 1  0/14 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Vascular disorders         
Hypertension * 1  3/14 (21.43%)  0/14 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Medical Director
Organization: Janssen Pharm KK Japan
Phone: 81-3-4411 ext 5509
Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT01606254     History of Changes
Other Study ID Numbers: CR013612
PALM-JPN-2 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
First Submitted: May 15, 2012
First Posted: May 25, 2012
Results First Submitted: March 4, 2013
Results First Posted: April 18, 2013
Last Update Posted: June 5, 2013