Clinical Trial Results:
A 2-Year, Open-Label, Single-Arm Safety Study of Flexibly Dosed Paliperidone Extended Release (1.5-12 mg/day) in the Treatment of Adolescents (12 to 17 Years of Age) With Schizophrenia
Due to a system error, the data reported in v1 is not correct and has been removed from public view.
Summary
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EudraCT number |
2007-000577-38 |
Trial protocol |
FI BE EE PL BG Outside EU/EEA |
Global end of trial date |
18 Jul 2012
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Results information
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Results version number |
v2(current) |
This version publication date |
02 Jun 2016
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First version publication date |
30 Jul 2015
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Other versions |
v1 (removed from public view) |
Version creation reason |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
R076477-PSZ-3002
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00488319 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Janssen-Cilag International NV
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Sponsor organisation address |
Turnhoutseweg 30, 2340 Beerse, Belgium,
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Public contact |
Janssen-Cilag International NV, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
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Scientific contact |
Janssen-Cilag International NV, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-000014-PIP01-07 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
18 Jul 2012
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
18 Jul 2012
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Global end of trial reached? |
Yes
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Global end of trial date |
18 Jul 2012
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of this study was to evaluate the long-term (2-year) safety and tolerability of paliperidone extended release (ER) in at least 100 adolescent subjects (12 to 17 years of age, inclusive) with schizophrenia.
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Protection of trial subjects |
This study had an independent Data Safety Monitoring Board (DSMB) to ensure subject safety throughout the study. Safety evaluations included monitoring of clinical laboratory tests (hematology, serum chemistry, lipid levels, fasting glucose, insulin and urinalysis), urine drug screen, vital sign measurements (temperature, pulse, and blood pressure), physical examinations and Tanner Staging, electrocardiograms (ECGs), pregnancy tests, investigation of weight gain, height, waist circumference and metabolic disturbances, monitoring of extrapyramidal symptoms (EPS), Columbia Suicide Severity Rating Scale, C-CASA assessment of potentially suicide-related events and other adverse events (included psychiatric adverse events).
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
27 Jun 2007
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety | ||
Long term follow-up duration |
2 Years | ||
Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Bulgaria: 6
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Country: Number of subjects enrolled |
Estonia: 3
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Country: Number of subjects enrolled |
Finland: 3
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Country: Number of subjects enrolled |
India: 64
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Country: Number of subjects enrolled |
Korea, Democratic People's Republic of: 40
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Country: Number of subjects enrolled |
Poland: 47
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Country: Number of subjects enrolled |
Romania: 20
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Country: Number of subjects enrolled |
Russian Federation: 109
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Country: Number of subjects enrolled |
Ukraine: 48
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Country: Number of subjects enrolled |
United States: 60
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Worldwide total number of subjects |
400
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EEA total number of subjects |
79
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
397
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Adults (18-64 years) |
3
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
This study evaluated the long-term (2 year) safety and tolerability of paliperidone ER in adolescent subjects with schizophrenia. This study was conducted from 27 June 2007 to 18 July 2012 at 55 centers in 10 countries. A total of 400 subjects received at least 1 dose of the study drug and were included in the safety analysis. | ||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Subjects enrolled in this study came from three different sources: subjects who enrolled directly, subjects who were randomly assigned to placebo in the R076477PSZ3001 (NCT00518323) study and subjects who were randomly assigned to paliperidone ER in the R076477PSZ3001 (NCT00518323) study. | ||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo/Pali | ||||||||||||||||||||||||||||||||||||
Arm description |
Subjects in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 milligram (mg) tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. | ||||||||||||||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Prolonged-release tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached.
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Arm title
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Pali (DB)/Pali | ||||||||||||||||||||||||||||||||||||
Arm description |
Subjects in this group were previously assigned to paliperidone ER in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. | ||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Paliperidone ER
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Investigational medicinal product code |
F071
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Other name |
INVEGA
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Pharmaceutical forms |
Prolonged-release tablet
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Routes of administration |
Oral use
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Dosage and administration details |
All enrolled subjects received a starting dose of paliperidone ER 6 mg daily and increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached.
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Arm title
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Pali (NO DB)/Pali | ||||||||||||||||||||||||||||||||||||
Arm description |
Subjects in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. | ||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Paliperidone ER
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Investigational medicinal product code |
F071
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Other name |
INVEGA
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Pharmaceutical forms |
Prolonged-release tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached.
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Baseline characteristics reporting groups
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Reporting group title |
Placebo/Pali
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Reporting group description |
Subjects in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 milligram (mg) tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Pali (DB)/Pali
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Reporting group description |
Subjects in this group were previously assigned to paliperidone ER in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Pali (NO DB)/Pali
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Reporting group description |
Subjects in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Placebo/Pali
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Reporting group description |
Subjects in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 milligram (mg) tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. | ||
Reporting group title |
Pali (DB)/Pali
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Reporting group description |
Subjects in this group were previously assigned to paliperidone ER in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. | ||
Reporting group title |
Pali (NO DB)/Pali
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Reporting group description |
Subjects in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
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End point title |
The Number of Subjects Who Experienced Adverse Events as a Measure of Safety and Tolerability [1] | ||||||||||||||||||||||||
End point description |
A serious adverse event (SAE) as defined by the International Conference on Harmonisation (ICH) is any untoward medical occurrence that at any dose results in death, is life-threatening (the subject was at risk of death at the time of the even; it does not refer to an event that hypothetically might have caused death if it were more severe), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. Safety analysis set included all subjects who received at least 1 dose of open label study drug.
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End point type |
Primary
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End point timeframe |
Up to 2 years
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive statistics were done, no inferential statistical analyses were performed. |
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No statistical analyses for this end point |
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End point title |
Change From Open-label Baseline to Open-label Endpoint in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Scores - Last Observation Carried Forward (LOCF) | ||||||||||||||||
End point 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). Efficacy analysis set included all ITT open-label subjects who received at least 1 dose of open label study drug and had at least 1 postbaseline assessment in open-label phase.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 104 or the last post-baseline assessment
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Notes [2] - 'N' signifies number of subjects analysed for this end point. [3] - 'N' signifies number of subjects analysed for this end point. |
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No statistical analyses for this end point |
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End point title |
Change From Open-label Baseline to Open-label Endpoint in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Based on Marder Factors - LOCF | ||||||||||||||||||||||||||||||||||||
End point description |
PANSS scale (30 item) for assessment of schizophrenia provides a total score and scores for 3 subscales, i.e., positive (7 items), negative (7 items), and general psychopathology (16 items) subscales. Each item is scored on a scale of 1 (absent) to 7 (extreme). Positive Factor Score (range: 8 to 56) and Disorganized Thoughts Factor Score (range: 7 to 49): sum of select scores from positive, negative and psychopathology subscales. Negative Factor Score (range: 7 to 49): sum of select scores from negative and general psychopathology subscales. Uncontrolled Hostility/Excitement Factor Score (range: 4 to 28): sum of select scores from positive and general psychopathology subscales. Anxiety or Depression Factor Score (range: 4 to 28): sum of select scores from general psychopathology subscale. Higher scores indicate worsening. Efficacy analysis set included all ITT open-label subjects who received at least 1 dose of study drug and had at least 1 postbaseline assessment in open-label phase.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 104 or the last post-baseline assessment
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Notes [4] - 'N' signifies number of subjects analysed for this end point. [5] - 'N' signifies number of subjects analysed for this end point. |
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No statistical analyses for this end point |
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End point title |
Change From Open-label Baseline to Open-label Endpoint in the Clinical Global Impression Severity (CGI-S) Scale - LOCF | ||||||||||||||||
End point description |
The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject. 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 subjects". Higher scores indicate worsening. Efficacy analysis set included all ITT open-label subjects who received at least 1 dose of open label study drug and had at least 1 postbaseline assessment in open-label phase.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 104 or the last post-baseline assessment
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Notes [6] - 'N' signifies number of subjects analysed for this end point. [7] - 'N' signifies number of subjects analysed for this end point. |
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No statistical analyses for this end point |
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End point title |
Change From Open-label Baseline to Open-label Endpoint in the Children’s Global Assessment Scale (CGAS) - LOCF | ||||||||||||||||
End point description |
The CGAS is a 100 point rating scale which measures the psychological, social, and school functioning for children 6 to 17 years of age. The score ranges from 1 to 100, divided into 10 equal intervals to rate the impairment level of general functioning (poor to superior functioning). Higher scores denote better functioning. Efficacy analysis set included all ITT open-label subjects who received at least 1 dose of open label study drug and had at least 1 postbaseline assessment in open-label phase.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 104 or the last post-baseline assessment
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Notes [8] - 'N' signifies number of subjects analysed for this end point. [9] - 'N' signifies number of subjects analysed for this end point. |
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No statistical analyses for this end point |
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End point title |
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Motor Speed Domain Test Variable, Finger Tapping Dominant- and Non-Dominant Hand, Scaled - LOCF | ||||||||||||||||||||||||
End point description |
A comprehensive neuropsychological examination that measures different domains of cognitive functioning was provided. They were either assessed as T-scores [mean=50, standard deviation (SD)=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. Efficacy analysis set included all ITT open-label subjects who received at least 1 dose of open label study drug and had at least 1 postbaseline assessment in open-label phase.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 24
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Notes [10] - 'N' signifies number of subjects analysed for this end point. [11] - 'N' signifies number of subjects analysed for this end point. [12] - 'N' signifies number of subjects analysed for this end point. |
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No statistical analyses for this end point |
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End point title |
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Attention/Working Memory Domain Test Variable Coding, Scaled - LOCF | ||||||||||||||||
End point description |
A comprehensive neuropsychological examination that measures different domains of cognitive functioning was provided. They were either assessed as T-scores [mean=50, SD =10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. Efficacy analysis set included all ITT open-label subjects who received at least 1 dose of open label study drug and had at least 1 postbaseline assessment in open-label phase.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 24
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Notes [13] - 'N' signifies number of subjects analysed for this end point. [14] - 'N' signifies number of subjects analysed for this end point. [15] - 'N' signifies number of subjects analysed for this end point. |
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No statistical analyses for this end point |
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End point title |
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Attention/Working Memory Domain Test Variable Digit Span, Scaled - LOCF | ||||||||||||||||
End point description |
A comprehensive neuropsychological examination that measures different domains of cognitive functioning was provided. They were either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. Efficacy analysis set included all ITT open-label subjects who received at least 1 dose of open label study drug and had at least 1 postbaseline assessment in open-label phase.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 24
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Notes [16] - 'N' signifies number of subjects analysed for this end point. [17] - 'N' signifies number of subjects analysed for this end point. [18] - 'N' signifies number of subjects analysed for this end point. |
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No statistical analyses for this end point |
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End point title |
Change From Open-label Baseline to Open-label - Cognitive Domain: Verbal Learning and Memory Domain Test Variable Wide Range Assessment of Memory and Learning Story - Total, Scaled - LOCF | ||||||||||||||||
End point description |
A comprehensive neuropsychological examination that measures different domains of cognitive functioning was provided. They were either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. Efficacy analysis set included all ITT open-label subjects who received at least 1 dose of open label study drug and had at least 1 postbaseline assessment in open-label phase. SD for Placebo/Paliperidone group in this end point was not estimable because only one subject was analysed for this end point. Therefore, value mentioned for SD is 99999= NA (Not Applicable).
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End point type |
Secondary
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End point timeframe |
Baseline, Week 24
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|||||||||||||||||
Notes [19] - 'N' signifies number of subjects analysed for this end point. [20] - 'N' signifies number of subjects analysed for this end point. [21] - 'N' signifies number of subjects analysed for this end point. |
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Verbal Learning and Memory Domain Test Variable California Verbal Learning Test-Total Trials, Scaled - LOCF | ||||||||||||||||
End point description |
A comprehensive neuropsychological examination that measures different domains of cognitive functioning was provided. They were either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. Efficacy analysis set included all ITT open-label subjects who received at least 1 dose of open label study drug and had at least 1 postbaseline assessment in open-label phase. SD for group Placebo/Paliperidone was not estimable because only one subject was analysed for this end point. Therefore, value mentioned for SD i.e. 99999= NA (Not Applicable).
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Baseline, Week 24
|
||||||||||||||||
|
|||||||||||||||||
Notes [22] - 'N' signifies number of subjects analysed for this end point. [23] - 'N' signifies number of subjects analysed for this end point. [24] - 'N' signifies number of subjects analysed for this end point. |
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Visual Learning and Memory Domain Test Variable, Rey Complex Figure Test - Total, Scaled - LOCF | ||||||||||||||||
End point description |
A comprehensive neuropsychological examination that measures different domains of cognitive functioning was provided. They were either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. Efficacy analysis set included all ITT open-label subjects who received at least 1 dose of open label study drug and had at least 1 postbaseline assessment in open-label phase.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Baseline, Week 24
|
||||||||||||||||
|
|||||||||||||||||
Notes [25] - 'N' signifies number of subjects analysed for this end point. [26] - 'N' signifies number of subjects analysed for this end point. [27] - 'N' signifies number of subjects analysed for this end point. |
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Change From Open Label Baseline to Open Label Endpoint - Cognitive Domain: Social Cognition Domain Test Variable - Theory of Mind-Total - LOCF | ||||||||||||||||
End point description |
A comprehensive neuropsychological examination that measures different domains of cognitive functioning was provided. They were either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. Efficacy analysis set included all ITT open-label subjects who received at least 1 dose of open label study drug and had at least 1 postbaseline assessment in open-label phase.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Baseline, Week 24
|
||||||||||||||||
|
|||||||||||||||||
Notes [28] - 'N' signifies number of subjects analysed for this end point. [29] - 'N' signifies number of subjects analysed for this end point. [30] - 'N' signifies number of subjects analysed for this end point. |
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Change From Open Label Baseline to Open Label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Trials Part A Time: Scaled - LOCF | ||||||||||||||||
End point description |
A comprehensive neuropsychological examination that measures different domains of cognitive functioning was provided. They were either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. Efficacy analysis set included all ITT open-label subjects who received at least 1 dose of open label study drug and had at least 1 postbaseline assessment in open-label phase.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Baseline, Week 24
|
||||||||||||||||
|
|||||||||||||||||
Notes [31] - 'N' signifies number of subjects analysed for this end point. [32] - 'N' signifies number of subjects analysed for this end point. [33] - 'N' signifies number of subjects analysed for this end point. |
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Child Color Trials Test 1 Time: Scaled - LOCF | ||||||||||||||||
End point description |
A comprehensive neuropsychological examination that measures different domains of cognitive functioning was provided. They were either assessed as T-scores [mean=50, SD =10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. Efficacy analysis set included all ITT open-label subjects who received at least 1 dose of open label study drug and had at least 1 postbaseline assessment in open-label phase.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Baseline, Week 24
|
||||||||||||||||
|
|||||||||||||||||
Notes [34] - 'N' signifies number of subjects analysed for this end point. [35] - 'N' signifies number of subjects analysed for this end point. [36] - 'N' signifies number of subjects analysed for this end point. |
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Phonetic Verbal Fluency: Scaled - LOCF | ||||||||||||||||
End point description |
A comprehensive neuropsychological examination that measures different domains of cognitive functioning was provided. They were either assessed as T-scores [mean=50, SD =10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. Efficacy analysis set included all ITT open-label subjects who received at least 1 dose of open label study drug and had at least 1 postbaseline assessment in open-label phase.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Baseline, Week 24
|
||||||||||||||||
|
|||||||||||||||||
Notes [37] - 'N' signifies number of subjects analysed for this end point. [38] - 'N' signifies number of subjects analysed for this end point. [39] - 'N' signifies number of subjects analysed for this end point. |
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Semantic Verbal Fluency, Scaled - LOCF | ||||||||||||||||
End point description |
A comprehensive neuropsychological examination that measures different domains of cognitive functioning was provided. They were either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. Efficacy analysis set included all ITT open-label subjects who received at least 1 dose of open label study drug and had at least 1 postbaseline assessment in open-label phase.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Baseline, Week 24
|
||||||||||||||||
|
|||||||||||||||||
Notes [40] - 'N' signifies number of subjects analysed for this end point. [41] - 'N' signifies number of subjects analysed for this end point. [42] - 'N' signifies number of subjects analysed for this end point. |
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Executive Functioning (Reasoning and Problem Solving) Domain Test Variable, Trials Part B Time, Scaled - LOCF | ||||||||||||||||
End point description |
A comprehensive neuropsychological examination that measures different domains of cognitive functioning was provided. They were either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. Efficacy analysis set included all ITT open-label subjects who received at least 1 dose of open label study drug and had at least 1 postbaseline assessment in open-label phase.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Baseline, Week 24
|
||||||||||||||||
|
|||||||||||||||||
Notes [43] - No subjects was analysed in Placebo/Paliperidone group for this end point. [44] - 'N' signifies number of subjects analysed for this end point. [45] - 'N' signifies number of subjects analysed for this end point. |
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Executive Functioning (Reasoning and Problem Solving) Domain Test Variable - Wisconsin Card Sort Test-Total Errors: Scaled - LOCF | ||||||||||||||||
End point description |
A comprehensive neuropsychological examination that measures different domains of cognitive functioning was provided. They were either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. Efficacy analysis set included all ITT open-label subjects who received at least 1 dose of open label study drug and had at least 1 postbaseline assessment in open-label phase.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Baseline, Week 24
|
||||||||||||||||
|
|||||||||||||||||
Notes [46] - 'N' signifies number of subjects analysed for this end point. [47] - 'N' signifies number of subjects analysed for this end point. [48] - 'N' signifies number of subjects analysed for this end point. |
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Change From Open-label Baseline to Open-label Endpoint in the Sleep Visual Analog Scale (VAS): Quality of Sleep - LOCF | ||||||||||||||||
End point description |
Sleep VAS is a self-administered scale that rates the quality of sleep and daytime drowsiness. Subjects make a mark on a line to represent how well they have slept in the previous 7 days (“very badly” to “very well”) and how often they have felt drowsy within the previous 7 days (“not at all” to “all the time”). The score for each item ranges from 0 to 100 millimeter (mm). For quality of sleep, a score of 0 indicates
“Very badly” and a score of 100 indicates “Very well.” For daytime drowsiness, a score of 0 indicates “Not at all” and a score of 100 indicates “All the time.” Improvement of the condition is indicated by the positive change for the quality of sleep and the negative change for the daytime drowsiness. Efficacy analysis set included all ITT open-label subjects who received at least 1 dose of open label study drug and had at least 1 postbaseline assessment in open-label phase.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Baseline, Week 104 or the last post-baseline assessment
|
||||||||||||||||
|
|||||||||||||||||
Notes [49] - 'N' signifies number of subjects analysed for this end point. [50] - 'N' signifies number of subjects analysed for this end point. [51] - 'N' signifies number of subjects analysed for this end point. |
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Change From Open-label Baseline to Open-label Endpoint in the Sleep Visual Analog Scale (VAS): Daytime Drowsiness - LOCF | ||||||||||||||||
End point description |
Sleep VAS is a self-administered scale that rates the quality of sleep and daytime drowsiness. Subjects make a mark on a line to represent how well they have slept in the previous 7 days (“very badly” to “very well”) and how often they have felt drowsy within the previous 7 days (“not at all” to “all the time”). The score for each item ranges from 0 to 100 mm. For quality of sleep, a score of 0 indicates “Very badly” and a score of 100 indicates “Very well.” For daytime drowsiness, a score of 0 indicates “Not at all” and a score of 100 indicates “All the time.” Improvement of the condition is indicated by the positive change for the quality of sleep and negative change for the daytime drowsiness. Efficacy analysis set included all ITT open-label subjects who received at least 1 dose of open label study drug and had at least 1 postbaseline assessment in open-label phase.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Baseline, Week 104 or the last post-baseline assessment
|
||||||||||||||||
|
|||||||||||||||||
Notes [52] - 'N' signifies number of subjects analysed for this end point. [53] - 'N' signifies number of subjects analysed for this end point. [54] - 'N' signifies number of subjects analysed for this end point. |
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
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Timeframe for reporting adverse events |
Up to 2 years
|
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.0
|
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Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo/Pali
|
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Reporting group description |
Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Pali (DB)/Pali
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Reporting group description |
Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Pali (NO DB)/Pali
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Reporting group description |
Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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22 May 2007 |
Amendment INT-1: Added clarification that an effective dose had to be 6 mg or less; the period of dose increments was modified; and the minimum weight required for inclusion in the study was lowered. |
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11 Jun 2008 |
Amendment INT 2: Extended the study duration from 6 months to 2 years; increased the number of visits, blood draws, evaluations, and dosing for the extended study duration; increased the sample size from 300 to 400 subjects; testing for testosterone in men was added to assess long-term endocrine effects; analyses were planned to be performed when 100 subjects completed at least 6 months of treatment and at the end of the 2-year study. |
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13 May 2009 |
Amendment INT-3: Included the C-SSRS as a safety assessment for Visits 2 to 19. |
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01 Apr 2010 |
Amendment INT-4: A statement was added which specified that stadiometers were required to measure subjects’ height. At the time of the amendment, 369 subjects were enrolled in the study. |
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14 May 2010 |
Amendment INT-5: Negative symptoms were added as a secondary end point. At the time of the amendment, 382 subjects were enrolled in the study. |
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04 Apr 2011 |
Amendment INT-6: Additional antiparkinsonian drugs (i.e. trihexyphenidyl, diphenhydramine, etc.) were added as alternatives to benztropine and biperiden for managing treatment-emergent EPS; the timing of study drug intake was adjusted based on subject tolerability and logistic reasons; and the eCRF completion period was changed from within 2 days to 3 days following a subject’s visit. At the time of the amendment, all subjects were enrolled in the study. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
The study was an open label study. Limitations also included the lack of a concurrent placebo group and small number of subjects in the lower age group. |