Trial Outcomes & Findings for An Efficacy Study of Paliperidone for the Prevention of Relapse in Participants With Schizophrenia (NCT NCT01662310)
NCT ID: NCT01662310
Last Updated: 2014-09-29
Results Overview
A relapse is defined as any one of the following: 1. involuntary or voluntary psychiatric hospitalization 2. deliberate self-injury or violent behavior; 3. Suicidal or homicidal ideation and clinically significant aggressive behavior; 4. 25 percent (%) increase in Positive and Negative Syndrome Scale (PANSS) total score for 2 consecutive assessments for participants whose score was greater than 40 at randomization, or a 10-point increase for participants who scored less than or equal to (≤) 40 at randomization; 5. increase for 2 consecutive assessments in PANSS items (delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, hostility or uncooperativeness) to greater than or equal to (≥) 5 for participants who scored ≤3 at randomization, or to ≥6 for participants with initial score of 4. Independent Data Monitoring Committee performed ongoing safety monitoring during double-blind treatment and conducted the interim analysis after 61 relapse events had taken place.
COMPLETED
PHASE3
201 participants
DB Baseline (Day 1 of Week 15) up to interim analysis data cut-off (24 August 2012) (Approximately 1 year)
2014-09-29
Participant Flow
Participant milestones
| Measure |
Paliperidone: Run-in or Stabilization Phase
Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 milligram per day (mg/day) after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
|
Paliperidone: Double Blind (DB) Phase
Participants who transitioned from run-in or stabilization phase received paliperidone at a starting dose of 3 mg up to 12 mg, fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
|
Placebo: DB Phase
Participants who transitioned from run-in or stabilization phase received matching placebo once daily during DB phase of the study.
|
Paliperidone DB/Paliperidone Open-label (OL) Extension Phase
Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
|
Placebo DB/Paliperidone OL Extension Phase
Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
|
|---|---|---|---|---|---|
|
Run-In or Stabilization Phase
STARTED
|
201
|
0
|
0
|
0
|
0
|
|
Run-In or Stabilization Phase
COMPLETED
|
136
|
0
|
0
|
0
|
0
|
|
Run-In or Stabilization Phase
NOT COMPLETED
|
65
|
0
|
0
|
0
|
0
|
|
Double-Blind Phase
STARTED
|
0
|
65
|
71
|
0
|
0
|
|
Double-Blind Phase
Treated
|
0
|
64
|
71
|
0
|
0
|
|
Double-Blind Phase
COMPLETED
|
0
|
50
|
66
|
0
|
0
|
|
Double-Blind Phase
NOT COMPLETED
|
0
|
15
|
5
|
0
|
0
|
|
Open-Label Extension Phase
STARTED
|
0
|
0
|
0
|
47
|
59
|
|
Open-Label Extension Phase
COMPLETED
|
0
|
0
|
0
|
36
|
49
|
|
Open-Label Extension Phase
NOT COMPLETED
|
0
|
0
|
0
|
11
|
10
|
Reasons for withdrawal
| Measure |
Paliperidone: Run-in or Stabilization Phase
Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 milligram per day (mg/day) after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
|
Paliperidone: Double Blind (DB) Phase
Participants who transitioned from run-in or stabilization phase received paliperidone at a starting dose of 3 mg up to 12 mg, fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
|
Placebo: DB Phase
Participants who transitioned from run-in or stabilization phase received matching placebo once daily during DB phase of the study.
|
Paliperidone DB/Paliperidone Open-label (OL) Extension Phase
Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
|
Placebo DB/Paliperidone OL Extension Phase
Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
|
|---|---|---|---|---|---|
|
Run-In or Stabilization Phase
Adverse Event
|
11
|
0
|
0
|
0
|
0
|
|
Run-In or Stabilization Phase
Lack of Efficacy
|
9
|
0
|
0
|
0
|
0
|
|
Run-In or Stabilization Phase
Lost to Follow-up
|
4
|
0
|
0
|
0
|
0
|
|
Run-In or Stabilization Phase
Protocol Violation
|
15
|
0
|
0
|
0
|
0
|
|
Run-In or Stabilization Phase
Withdrawal by Subject
|
25
|
0
|
0
|
0
|
0
|
|
Run-In or Stabilization Phase
Other
|
1
|
0
|
0
|
0
|
0
|
|
Double-Blind Phase
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
|
Double-Blind Phase
Lost to Follow-up
|
0
|
3
|
0
|
0
|
0
|
|
Double-Blind Phase
Pregnancy
|
0
|
2
|
0
|
0
|
0
|
|
Double-Blind Phase
Withdrawal by Subject
|
0
|
9
|
3
|
0
|
0
|
|
Double-Blind Phase
Other
|
0
|
0
|
1
|
0
|
0
|
|
Double-Blind Phase
Randomized but not treated
|
0
|
1
|
0
|
0
|
0
|
|
Open-Label Extension Phase
Adverse Event
|
0
|
0
|
0
|
3
|
0
|
|
Open-Label Extension Phase
Death
|
0
|
0
|
0
|
1
|
0
|
|
Open-Label Extension Phase
Lack of Efficacy
|
0
|
0
|
0
|
2
|
2
|
|
Open-Label Extension Phase
Lost to Follow-up
|
0
|
0
|
0
|
2
|
1
|
|
Open-Label Extension Phase
Pregnancy
|
0
|
0
|
0
|
1
|
0
|
|
Open-Label Extension Phase
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
7
|
Baseline Characteristics
An Efficacy Study of Paliperidone for the Prevention of Relapse in Participants With Schizophrenia
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=201 Participants
All the participants who were enrolled.
|
|---|---|
|
Age, Continuous
|
31.3 years
STANDARD_DEVIATION 10.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: DB Baseline (Day 1 of Week 15) up to interim analysis data cut-off (24 August 2012) (Approximately 1 year)Population: The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication up to interim analysis cut-off date (24-Aug-2012). "N" (number of participants analyzed) signifies the participants evaluable for this measure.
A relapse is defined as any one of the following: 1. involuntary or voluntary psychiatric hospitalization 2. deliberate self-injury or violent behavior; 3. Suicidal or homicidal ideation and clinically significant aggressive behavior; 4. 25 percent (%) increase in Positive and Negative Syndrome Scale (PANSS) total score for 2 consecutive assessments for participants whose score was greater than 40 at randomization, or a 10-point increase for participants who scored less than or equal to (≤) 40 at randomization; 5. increase for 2 consecutive assessments in PANSS items (delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, hostility or uncooperativeness) to greater than or equal to (≥) 5 for participants who scored ≤3 at randomization, or to ≥6 for participants with initial score of 4. Independent Data Monitoring Committee performed ongoing safety monitoring during double-blind treatment and conducted the interim analysis after 61 relapse events had taken place.
Outcome measures
| Measure |
Paliperidone: Double Blind (DB) Phase
n=59 Participants
Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
|
Placebo: DB Phase
n=65 Participants
Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
|
|---|---|---|
|
Double Blind (DB) Phase: Median Time to Relapse
|
NA Days
Median time was not reached as data was not matured at the time of the analysis, hence no data could be reported.
|
49.0 Days
Interval 22.0 to 77.0
|
SECONDARY outcome
Timeframe: Baseline and Week 14Population: The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. "n" signifies those participants who were evaluated for this measure at the specified time point. Last observation carried forward (LOCF) method was used to impute missing values.
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
Outcome measures
| Measure |
Paliperidone: Double Blind (DB) Phase
n=201 Participants
Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
|
Placebo: DB Phase
Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
|
|---|---|---|
|
Run-In and Stabilization Phase: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 14
Baseline (n=201)
|
89.5 Units on a scale
Standard Deviation 12.48
|
—
|
|
Run-In and Stabilization Phase: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 14
Change at Week 14 (n=200)
|
-30.8 Units on a scale
Standard Deviation 18.55
|
—
|
SECONDARY outcome
Timeframe: DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])Population: The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication. LOCF method was used to impute missing values.
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).
Outcome measures
| Measure |
Paliperidone: Double Blind (DB) Phase
n=64 Participants
Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
|
Placebo: DB Phase
n=71 Participants
Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
|
|---|---|---|
|
Double Blind (DB) Phase: Change From DB Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at DB Endpoint
Baseline
|
53.4 Units on a scale
Standard Deviation 9.71
|
51.5 Units on a scale
Standard Deviation 9.50 • Interval 29.0 to 77.0
|
|
Double Blind (DB) Phase: Change From DB Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at DB Endpoint
Change at DB endpoint
|
2.0 Units on a scale
Standard Deviation 12.67
|
16.9 Units on a scale
Standard Deviation 16.16
|
SECONDARY outcome
Timeframe: Baseline and Week 14Population: The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. "n" signifies those participants who were evaluated for this measure at the specified time point.
The CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill.
Outcome measures
| Measure |
Paliperidone: Double Blind (DB) Phase
n=201 Participants
Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
|
Placebo: DB Phase
Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
|
|---|---|---|
|
Run-In and Stabilization Phase: Number of Participants Assessed With Categorical Scores Based on Clinical Global Impression-Severity Scale (CGI-S)
Not ill: Baseline (n=201)
|
0 Participants
12.48
|
—
|
|
Run-In and Stabilization Phase: Number of Participants Assessed With Categorical Scores Based on Clinical Global Impression-Severity Scale (CGI-S)
Not ill: Week 14 (n= 135)
|
2 Participants
18.49
|
—
|
|
Run-In and Stabilization Phase: Number of Participants Assessed With Categorical Scores Based on Clinical Global Impression-Severity Scale (CGI-S)
Very Mild: Baseline (n= 201)
|
0 Participants
|
—
|
|
Run-In and Stabilization Phase: Number of Participants Assessed With Categorical Scores Based on Clinical Global Impression-Severity Scale (CGI-S)
Very Mild: Week 14 (n= 135)
|
37 Participants
|
—
|
|
Run-In and Stabilization Phase: Number of Participants Assessed With Categorical Scores Based on Clinical Global Impression-Severity Scale (CGI-S)
Mild: Baseline (n= 201)
|
3 Participants
|
—
|
|
Run-In and Stabilization Phase: Number of Participants Assessed With Categorical Scores Based on Clinical Global Impression-Severity Scale (CGI-S)
Mild: Week 14 (n= 135)
|
65 Participants
|
—
|
|
Run-In and Stabilization Phase: Number of Participants Assessed With Categorical Scores Based on Clinical Global Impression-Severity Scale (CGI-S)
Moderate: Baseline (n= 201)
|
41 Participants
|
—
|
|
Run-In and Stabilization Phase: Number of Participants Assessed With Categorical Scores Based on Clinical Global Impression-Severity Scale (CGI-S)
Moderate: Week 14 (n= 135)
|
27 Participants
|
—
|
|
Run-In and Stabilization Phase: Number of Participants Assessed With Categorical Scores Based on Clinical Global Impression-Severity Scale (CGI-S)
Marked: Baseline (n= 201)
|
91 Participants
|
—
|
|
Run-In and Stabilization Phase: Number of Participants Assessed With Categorical Scores Based on Clinical Global Impression-Severity Scale (CGI-S)
Marked: Week 14 (n= 135)
|
4 Participants
|
—
|
|
Run-In and Stabilization Phase: Number of Participants Assessed With Categorical Scores Based on Clinical Global Impression-Severity Scale (CGI-S)
Severe: Baseline (n= 201)
|
66 Participants
|
—
|
|
Run-In and Stabilization Phase: Number of Participants Assessed With Categorical Scores Based on Clinical Global Impression-Severity Scale (CGI-S)
Severe: Week 14 (n= 135)
|
0 Participants
|
—
|
|
Run-In and Stabilization Phase: Number of Participants Assessed With Categorical Scores Based on Clinical Global Impression-Severity Scale (CGI-S)
Extremely Severe: Baseline (n= 201)
|
0 Participants
|
—
|
|
Run-In and Stabilization Phase: Number of Participants Assessed With Categorical Scores Based on Clinical Global Impression-Severity Scale (CGI-S)
Extremely Severe: Week 14 (n= 135)
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])Population: The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication.
CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).
Outcome measures
| Measure |
Paliperidone: Double Blind (DB) Phase
n=64 Participants
Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
|
Placebo: DB Phase
n=71 Participants
Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
|
|---|---|---|
|
Double Blind (DB) Phase: Change From DB Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at DB Endpoint
Baseline
|
3.0 Units on a scale
Standard Deviation 0.88
|
2.9 Units on a scale
Standard Deviation 0.70 • Interval 29.0 to 77.0
|
|
Double Blind (DB) Phase: Change From DB Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at DB Endpoint
Change at DB endpoint
|
0.1 Units on a scale
Standard Deviation 0.91
|
1.1 Units on a scale
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: Baseline and Week 14Population: The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. "n" signifies those participants who were evaluated for this measure at the specified time point. LOCF method was used to impute missing values.
The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported.
Outcome measures
| Measure |
Paliperidone: Double Blind (DB) Phase
n=201 Participants
Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
|
Placebo: DB Phase
Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
|
|---|---|---|
|
Run-In and Stabilization Phase: Change From Baseline in Personal and Social Performance (PSP) Scale Total Score at Week 14
Baseline (n=201)
|
43.6 Units on a scale
Standard Deviation 13.96
|
—
|
|
Run-In and Stabilization Phase: Change From Baseline in Personal and Social Performance (PSP) Scale Total Score at Week 14
Change at Week 14 (n=200)
|
20.9 Units on a scale
Standard Deviation 17.55
|
—
|
SECONDARY outcome
Timeframe: DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])Population: The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication.
The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).
Outcome measures
| Measure |
Paliperidone: Double Blind (DB) Phase
n=64 Participants
Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
|
Placebo: DB Phase
n=71 Participants
Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
|
|---|---|---|
|
Double Blind (DB) Phase: Change From DB Baseline in Personal and Social Performance (PSP) Scale Total Score at DB Endpoint
Baseline
|
69.3 Units on a scale
Standard Deviation 11.17
|
69.9 Units on a scale
Standard Deviation 9.37 • Interval 29.0 to 77.0
|
|
Double Blind (DB) Phase: Change From DB Baseline in Personal and Social Performance (PSP) Scale Total Score at DB Endpoint
Change at DB Endpoint
|
-2.9 Units on a scale
Standard Deviation 12.87
|
-10.7 Units on a scale
Standard Deviation 14.99
|
SECONDARY outcome
Timeframe: Baseline and Week 14Population: The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. "n" signifies those participants who were evaluated for this measure at the specified time point. LOCF method was used to impute missing values.
Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: "very badly" to 100: "very well").
Outcome measures
| Measure |
Paliperidone: Double Blind (DB) Phase
n=201 Participants
Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
|
Placebo: DB Phase
Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
|
|---|---|---|
|
Run-In and Stabilization Phase: Change From Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at Week 14
Change at Week 14 (n=192)
|
12.1 Millimeter (mm)
Standard Deviation 29.13
|
—
|
|
Run-In and Stabilization Phase: Change From Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at Week 14
Baseline (n=201)
|
63.4 Millimeter (mm)
Standard Deviation 24.60
|
—
|
SECONDARY outcome
Timeframe: DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])Population: The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication. "n" signifies those participants who were evaluated for this measure at the specified time point.
Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: "very badly" to 100: "very well"). Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).
Outcome measures
| Measure |
Paliperidone: Double Blind (DB) Phase
n=64 Participants
Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
|
Placebo: DB Phase
n=71 Participants
Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
|
|---|---|---|
|
Double Blind (DB) Phase: Change From DB Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at DB Endpoint
Baseline (n= 64, 71)
|
77.5 Millimeter (mm)
Standard Deviation 20.45
|
81.9 Millimeter (mm)
Standard Deviation 14.82 • Interval 29.0 to 77.0
|
|
Double Blind (DB) Phase: Change From DB Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at DB Endpoint
Change at DB Endpoint (n= 60, 69)
|
-3.8 Millimeter (mm)
Standard Deviation 20.02
|
-22.4 Millimeter (mm)
Standard Deviation 27.88
|
SECONDARY outcome
Timeframe: Baseline and Week 14Population: The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. "n" signifies those participants who were evaluated for this measure at the specified time point. LOCF method was used to impute missing values.
Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: "very badly" to 100: "very well").
Outcome measures
| Measure |
Paliperidone: Double Blind (DB) Phase
n=201 Participants
Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
|
Placebo: DB Phase
Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
|
|---|---|---|
|
Run-In and Stabilization Phase: Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at Week 14
Baseline (n=201)
|
32.8 Millimeter (mm)
Standard Deviation 27.03
|
—
|
|
Run-In and Stabilization Phase: Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at Week 14
Change at Week 14 (n=192)
|
-7.3 Millimeter (mm)
Standard Deviation 33.73
|
—
|
SECONDARY outcome
Timeframe: DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])Population: The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication. "n" signifies those participants who were evaluated for this measure at the specified time point.
Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: "very badly" to 100: "very well"). Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).
Outcome measures
| Measure |
Paliperidone: Double Blind (DB) Phase
n=64 Participants
Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
|
Placebo: DB Phase
n=71 Participants
Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
|
|---|---|---|
|
Double Blind (DB) Phase: Change From DB Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at DB Endpoint
Baseline (n= 64, 71)
|
22.9 Millimeter (mm)
Standard Deviation 24.24
|
24.4 Millimeter (mm)
Standard Deviation 22.93 • Interval 29.0 to 77.0
|
|
Double Blind (DB) Phase: Change From DB Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at DB Endpoint
Change at DB Endpoint (n= 60, 69)
|
3.1 Millimeter (mm)
Standard Deviation 23.18
|
1.2 Millimeter (mm)
Standard Deviation 28.50
|
SECONDARY outcome
Timeframe: DB Baseline (Day 1 of Week 15) up to study completion (09 November 2012) (Approximately 1 year)Population: The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication up to final analysis cut-off date (09-Nov-2012).
A relapse is defined as any one of the following: 1. involuntary or voluntary psychiatric hospitalization 2. deliberate self-injury or violent behavior; 3. Suicidal or homicidal ideation and clinically significant aggressive behavior; 4. 25 percent (%) increase in Positive and Negative Syndrome Scale (PANSS) total score for 2 consecutive assessments for participants whose score was greater than 40 at randomization, or a 10-point increase for participants who scored less than or equal to (≤) 40 at randomization; 5. increase for 2 consecutive assessments in PANSS items (delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, hostility or uncooperativeness) to greater than or equal to (≥) 5 for participants who scored ≤3 at randomization, or to ≥6 for participants with initial score of 4. Independent Data Monitoring Committee performed final analysis at the end of double-blind treatment (09 November 2012).
Outcome measures
| Measure |
Paliperidone: Double Blind (DB) Phase
n=64 Participants
Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
|
Placebo: DB Phase
n=71 Participants
Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
|
|---|---|---|
|
Double Blind (DB) Phase: Median Time to Relapse (Final Analysis)
|
NA Days
Median time was not reached as data was not matured at the time of the analysis, hence no data could be reported.
|
52.0 Days
Interval 29.0 to 77.0
|
SECONDARY outcome
Timeframe: OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)Population: The Intent-to-Treat (ITT) OLE analysis set included all participants who received at least one dose of OLE medication as recorded on the electronic case report form (eCRF). LOCF method was used to impute missing values. "N" (number of participants analyzed) signifies the participants evaluable for this measure.
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).
Outcome measures
| Measure |
Paliperidone: Double Blind (DB) Phase
n=46 Participants
Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
|
Placebo: DB Phase
n=59 Participants
Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
|
|---|---|---|
|
Open-label Extension (OLE) Phase: Change From OLE Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at OLE Endpoint
Baseline
|
56.5 Units on a scale
Standard Deviation 14.86
|
67.2 Units on a scale
Standard Deviation 14.67 • Interval 29.0 to 77.0
|
|
Open-label Extension (OLE) Phase: Change From OLE Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at OLE Endpoint
Change at OLE endpoint
|
-3.9 Units on a scale
Standard Deviation 11.30
|
-15.4 Units on a scale
Standard Deviation 12.41
|
SECONDARY outcome
Timeframe: OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)Population: The ITT OLE analysis set included all participants who received at least one dose of OLE medication as recorded on the electronic case report form (eCRF). LOCF method was used to impute missing values. "N" (number of participants analyzed) signifies the participants evaluable for this measure.
CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).
Outcome measures
| Measure |
Paliperidone: Double Blind (DB) Phase
n=46 Participants
Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
|
Placebo: DB Phase
n=59 Participants
Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
|
|---|---|---|
|
Open-label Extension (OLE) Phase: Change From OLE Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at OLE Endpoint
Baseline
|
3.1 Units on a scale
Standard Deviation 1.02
|
3.9 Units on a scale
Standard Deviation 0.98 • Interval 29.0 to 77.0
|
|
Open-label Extension (OLE) Phase: Change From OLE Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at OLE Endpoint
Change at OLE endpoint
|
-0.2 Units on a scale
Standard Deviation 0.78
|
-0.9 Units on a scale
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)Population: The ITT OLE analysis set included all participants who received at least one dose of OLE medication as recorded on the electronic case report form (eCRF). LOCF method was used to impute missing values. "N" (number of participants analyzed) signifies the participants evaluable for this measure.
The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).
Outcome measures
| Measure |
Paliperidone: Double Blind (DB) Phase
n=46 Participants
Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
|
Placebo: DB Phase
n=59 Participants
Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
|
|---|---|---|
|
Open-label Extension (OLE) Phase: Change From OLE Baseline in Personal and Social Performance (PSP) Scale Total Score at OLE Endpoint
Baseline
|
66.8 Units on a scale
Standard Deviation 15.68
|
60.6 Units on a scale
Standard Deviation 15.63 • Interval 29.0 to 77.0
|
|
Open-label Extension (OLE) Phase: Change From OLE Baseline in Personal and Social Performance (PSP) Scale Total Score at OLE Endpoint
Change at OLE endpoint
|
10.88 Units on a scale
Standard Deviation 3.1
|
10.7 Units on a scale
Standard Deviation 14.01
|
Adverse Events
Paliperidone: Run-in or Stabilization Phase
Paliperidone: Double Blind (DB) Phase
Placebo: DB Phase
Paliperidone DB/Paliperidone Open-label (OL) Extension Phase
Placebo DB/Paliperidone OL Extension Phase
Serious adverse events
| Measure |
Paliperidone: Run-in or Stabilization Phase
n=201 participants at risk
Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
|
Paliperidone: Double Blind (DB) Phase
n=64 participants at risk
Participants who transitioned from run-in or stabilization phase received paliperidone at a starting dose of 3 mg up to 12 mg, fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
|
Placebo: DB Phase
n=71 participants at risk
Participants who transitioned from run-in or stabilization phase received matching placebo once daily during DB phase of the study.
|
Paliperidone DB/Paliperidone Open-label (OL) Extension Phase
n=47 participants at risk
Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
|
Placebo DB/Paliperidone OL Extension Phase
n=59 participants at risk
Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
|
|---|---|---|---|---|---|
|
Psychiatric disorders
Aggression
|
0.00%
0/201
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/64
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
1.4%
1/71
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/47
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/59
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
|
Psychiatric disorders
Completed Suicide
|
0.00%
0/201
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/64
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
1.4%
1/71
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
2.1%
1/47
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/59
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
|
Psychiatric disorders
Hallucination, Auditory
|
0.00%
0/201
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/64
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
1.4%
1/71
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/47
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/59
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
|
Psychiatric disorders
Psychotic Disorder
|
0.50%
1/201
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/64
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/71
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/47
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/59
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
|
Psychiatric disorders
Schizophrenia
|
0.50%
1/201
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
1.6%
1/64
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
7.0%
5/71
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
2.1%
1/47
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/59
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/201
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
1.6%
1/64
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/71
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/47
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/59
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
Other adverse events
| Measure |
Paliperidone: Run-in or Stabilization Phase
n=201 participants at risk
Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
|
Paliperidone: Double Blind (DB) Phase
n=64 participants at risk
Participants who transitioned from run-in or stabilization phase received paliperidone at a starting dose of 3 mg up to 12 mg, fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
|
Placebo: DB Phase
n=71 participants at risk
Participants who transitioned from run-in or stabilization phase received matching placebo once daily during DB phase of the study.
|
Paliperidone DB/Paliperidone Open-label (OL) Extension Phase
n=47 participants at risk
Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
|
Placebo DB/Paliperidone OL Extension Phase
n=59 participants at risk
Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
6.0%
12/201
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/64
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
1.4%
1/71
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/47
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/59
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
|
Ear and labyrinth disorders
Vertigo
|
9.5%
19/201
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
1.6%
1/64
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
1.4%
1/71
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/47
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/59
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
|
Eye disorders
Vision Blurred
|
6.5%
13/201
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
1.6%
1/64
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/71
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/47
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/59
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
|
Gastrointestinal disorders
Constipation
|
9.5%
19/201
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
1.6%
1/64
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/71
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
4.3%
2/47
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
3.4%
2/59
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
|
Gastrointestinal disorders
Nausea
|
6.0%
12/201
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
3.1%
2/64
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
1.4%
1/71
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/47
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/59
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
|
Infections and infestations
Nasopharyngitis
|
8.5%
17/201
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/64
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
2.8%
2/71
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
2.1%
1/47
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
5.1%
3/59
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
6.0%
12/201
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
1.6%
1/64
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
1.4%
1/71
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
2.1%
1/47
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
1.7%
1/59
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
|
Investigations
Weight Increased
|
6.5%
13/201
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
1.6%
1/64
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
1.4%
1/71
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/47
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
3.4%
2/59
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
|
Nervous system disorders
Akathisia
|
25.9%
52/201
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
4.7%
3/64
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/71
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
2.1%
1/47
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
5.1%
3/59
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
|
Nervous system disorders
Dyskinesia
|
5.5%
11/201
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/64
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
1.4%
1/71
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/47
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/59
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
|
Nervous system disorders
Dystonia
|
5.5%
11/201
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/64
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/71
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/47
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
1.7%
1/59
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
|
Nervous system disorders
Headache
|
5.5%
11/201
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
1.6%
1/64
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/71
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
2.1%
1/47
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
1.7%
1/59
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
|
Nervous system disorders
Hypertonia
|
7.0%
14/201
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/64
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/71
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/47
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/59
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
|
Nervous system disorders
Somnolence
|
9.5%
19/201
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/64
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/71
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
2.1%
1/47
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
5.1%
3/59
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
|
Nervous system disorders
Tremor
|
11.9%
24/201
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
3.1%
2/64
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/71
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/47
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/59
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
|
Psychiatric disorders
Insomnia
|
10.4%
21/201
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
1.6%
1/64
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
8.5%
6/71
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
2.1%
1/47
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
1.7%
1/59
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
|
Psychiatric disorders
Restlessness
|
6.0%
12/201
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
1.6%
1/64
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/71
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
0.00%
0/47
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
3.4%
2/59
Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
|
Additional Information
Senior Director Clinical Leader
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Results disclosure agreements
- Principal investigator is a sponsor employee If an Investigator wishes to publish information from study, a copy of the manuscript must be provided to the Sponsor for review at least 60 days before submission for publication or presentation. If requested by the Sponsor, investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application. Investigators will not publish data derived from individual site until Sponsor confirms there will be no multi-center study publication.
- Publication restrictions are in place
Restriction type: OTHER