Clinical Trial Results:
26-week open-label extension study evaluating the safety and tolerability of flexible doses of oral ziprasidone in adolescent subjects with schizophrenia.
Summary
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EudraCT number |
2005-005502-23 |
Trial protocol |
SE DE |
Global end of trial date |
16 Apr 2009
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Results information
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Results version number |
v2(current) |
This version publication date |
25 May 2016
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First version publication date |
23 Jul 2015
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Other versions |
v1 |
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 |
A1281135
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00265382 | ||
WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Pfizer Inc.
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Sponsor organisation address |
235 E 42nd Street, New York, United States, NY 10017
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Public contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 00 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
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Scientific contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 00 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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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 |
30 Nov 2011
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
16 Apr 2009
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To assess the safety and tolerability of oral ziprasidone (40-80 milligram [mg] twice a day [BID]) during long-term, open-label administration in adolescent subjects with schizophrenia.
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
15 Jun 2006
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Long term follow-up planned |
No
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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 |
Singapore: 2
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Country: Number of subjects enrolled |
United States: 44
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Country: Number of subjects enrolled |
India: 28
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Country: Number of subjects enrolled |
Russian Federation: 66
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Country: Number of subjects enrolled |
Malaysia: 14
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Country: Number of subjects enrolled |
Peru: 8
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Country: Number of subjects enrolled |
Costa Rica: 3
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Country: Number of subjects enrolled |
Ukraine: 48
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Country: Number of subjects enrolled |
Colombia: 8
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Worldwide total number of subjects |
221
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EEA total number of subjects |
0
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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) |
221
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Adults (18-64 years) |
0
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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 enrolled adolescent subjects with schizophrenia, ages 13-17 years, who participated in the double-blind placebo controlled Study A1281134 (Eudract Number: 2005-005502-23) (NCT00257192) who met qualification criteria and wished to receive treatment with open-label ziprasidone. | ||||||||||||||||||||||||
Pre-assignment
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Screening details |
The study was conducted at 60 centers in 9 countries between 15 June 2006 to 16 April 2009. | ||||||||||||||||||||||||
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 |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||||||
Arms
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Arm title
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Ziprasidone | ||||||||||||||||||||||||
Arm description |
Ziprasidone capsules administered BID with meals. | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Ziprasidone
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing >=45 kilograms (kg). For subjects with a body weight <45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
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Baseline characteristics reporting groups
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Reporting group title |
Ziprasidone
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Reporting group description |
Ziprasidone capsules administered BID with meals. | |||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Ziprasidone
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Reporting group description |
Ziprasidone capsules administered BID with meals. |
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End point title |
Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [1] | ||||||||||
End point description |
All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported. Safety Analysis Set = all subjects who took at least one dose of study medication. In this table, the number of subjects with AEs is based on a 0 percent (%) AE threshold whereas the number of subjects with AEs reported in the AE section are based on a 5% AE threshold.
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End point type |
Primary
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End point timeframe |
26 weeks
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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: no statistical analysis conducted. |
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No statistical analyses for this end point |
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End point title |
Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment | ||||||||||||||||||||||||||
End point description |
Tanner Adolescent Pubertal Staging Questionnaire: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; males pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Safety Analysis Set. Baseline data from Study A1281134 (Eudract Number: 2005-005502-23) (NCT00257192) served as the baseline for A1281135.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 26, Early Termination (ET)
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Notes [2] - N=number of subjects with analyzable data at baseline. |
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No statistical analyses for this end point |
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End point title |
Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score | ||||||||||||||||||||
End point description |
CPBAQ: 19-item parent or legal guardian completed questionnaire to rate the child's verbal (such as yelling or cursing) and physical aggression (such a fighting with peers or being cruel to an animal) during the past week. Behavior was rated on a 4-point scale; range 0 (behavior did not occur or was not a problem) to 3 (behavior occurred a lot or was severe problem). Total score range 0 to 57; higher scores indicate a greater frequency and severity of aggression. Safety Analysis Set. n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (EudraCT Number: 2005-005502-23) (NCT00257192). Last Observation Carried Forward (LOCF) imputation used for Week 26 LOCF time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 2, 6, 18, 26, ET
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Notes [3] - N=number of subjects with analyzable data at baseline. |
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No statistical analyses for this end point |
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End point title |
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score | ||||||||||||||||||||||||||||
End point description |
CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Safety Analysis Set. n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (EudraCT Number: 2005-005502-23) (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET
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Notes [4] - N=number of subjects with analyzable data at baseline. |
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No statistical analyses for this end point |
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End point title |
Change From Baseline in Central Nervous System (CNS) Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, sustained attention. Computerized 7- point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. Neurocognitive index score was derived from subtest scores per an algorithm. Index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79). Safety Analysis Set. n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (EudraCT Number: 2005-005502-23) (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 6 and 26, ET
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Notes [5] - N=number of subjects with analyzable data at baseline. |
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No statistical analyses for this end point |
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End point title |
Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index | ||||||||||||||||
End point description |
Computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, sustained attention. Computerized 7- point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. Neurocognitive index score was derived from subtest scores per an algorithm. Index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79). Safety Analysis Set. n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (EudraCT Number: 2005-005502-23) (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 6 and 26, ET
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Notes [6] - N=number of subjects with analyzable data at baseline. |
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No statistical analyses for this end point |
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End point title |
Change From Baseline in Simpson-Angus Rating Scale (SARS) | ||||||||||||||||||||||||||||
End point description |
SARS: 10-item clinician rated instrument to assess parkinsonian symptoms (7 items) and related extrapyramidal side effects (3 items): gait, arm dropping, shoulder shaking, elbow rigidity, leg pendulousness, glabellar tap, tremor, and salivation. Head dropping (modified SARS item 7) substituted for head rotation. Anchored 5-point scale: range 0 (absence of condition, normal) to 4 (most extreme form of condition). Total score is sum of individual item scores (range 0 to 40); higher score indicates more affected. Safety Analysis Set. n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (EudraCT Number: 2005-005502-23) (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET
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Notes [7] - N=number of subjects with analyzable data at baseline. |
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No statistical analyses for this end point |
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End point title |
Change From Baseline in Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item | ||||||||||||||||||||||||||||
End point description |
BAS: clinician rated scale to assess akathisia to determine the degree of subjective restlessness and distress associated with restlessness. First 3 items (Objective, Subjective, and Distress related to restlessness) rated on a 4-point scale with range 0 (no symptoms) to 3 (increased severity of symptoms). Item 4 Global Clinical Assessment of Akathisia rated on a 6-point scale range 0 (no symptoms) to 5 (increased severity of symptoms); higher score indicates increased severity. All rating are anchored. Only the Global Clinical Assessment of Akathisia was to be analyzed.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET
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No statistical analyses for this end point |
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End point title |
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score | ||||||||||||||||||||||||||||
End point description |
AIMS: clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe) (total possible score 0 to 40; higher score indicates greater severity); items 11 to 14 are No or Yes response to dental status and sleep movements. Only the sum of the first 7 items to be analyzed (AIMS Movement Cluster score). Total score 0 to 28; higher score indicates greater severity. Safety Analysis Set. n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (EudraCT Number: 2005-005502-23) (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET
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Notes [8] - N=number of subjects with analyzable data at baseline. |
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No statistical analyses for this end point |
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End point title |
Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score | ||||||||||||||||||||
End point description |
BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, excitement. Ratings anchored to improve consistency for single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology. Safety Analysis Set. n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (EudraCT Number: 2005-005502-23) (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 2, 6, 18, 26, ET
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Notes [9] - N=number of subjects with analyzable data at baseline. |
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No statistical analyses for this end point |
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End point title |
Change From Baseline in Children's Global Assessment Scale (CGAS) | ||||||||||||||||||||
End point description |
CGAS: clinician-rated global assessment item for children based on symptoms and social functioning in home, school, and community settings. Scores on this single item range from 1 to 100 (higher levels indicate greater health) with descriptive anchors for every 10-point interval. Scores above 70 on this scale are considered within the "normal" range; lower score indicates need for increased supervision. Safety Analysis Set. n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (EudraCT Number: 2005-005502-23) (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 2, 6, 18, 26, ET
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Notes [10] - N=number of subjects with analyzable data at baseline. |
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No statistical analyses for this end point |
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End point title |
Change From Baseline in Child Health Questionnaire (CHQ) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status. Safety Analysis Set. n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (EudraCT Number: 2005-005502-23) (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 6 and 26, ET
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Notes [11] - N=number of subjects with analyzable data at baseline. |
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No statistical analyses for this end point |
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End point title |
Number of Subjects Per Response on the School Placement Questionnaire: School Situation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school. Safety Analysis Set. n=number of subjects with analyzable data at baseline and post-baseline observation. Baseline was the last available observation from Study A1281134 (EudraCT Number: 2005-005502-23) (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 6 and 26, ET
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Notes [12] - N=number of subjects analyzable for School Placement Questionnaire. |
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No statistical analyses for this end point |
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End point title |
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school. Safety Analysis Set. n=number of subjects with analyzable data at baseline and post-baseline observation. Baseline was the last available observation from Study A1281134 (EudraCT Number: 2005-005502-23) (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 6 and 26, ET
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Notes [13] - N=number of subjects analyzable for School Placement Questionnaire. |
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No statistical analyses for this end point |
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End point title |
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school. Safety Analysis Set. n=number of subjects with analyzable data at baseline and post-baseline observation. Baseline was the last available observation from Study A1281134 (EudraCT Number: 2005-005502-23) (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 6 and 26, ET
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Notes [14] - N=number of subjects analyzable for School Placement Questionnaire. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
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Adverse event reporting additional description |
Safety population= all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may= serious for 1 subject and= non-serious for another subject or subject may have experienced both serious and non-serious episode of the same event.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.1
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Reporting groups
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Reporting group title |
Ziprasidone
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Reporting group description |
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing >=45 kg. For subjects with a body weight <45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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06 Dec 2006 |
1. Electrocardiograms (ECGs) showing a Fridericia corrected QT (QTcF) of >=460 milliseconds (msec) or a suspected increase from baseline of 60 msec or greater was to be repeated within the same visit. If the QTcF value persisted at >=460 msec and/or the change from baseline. persisted at >=60 msec, the study drug was to be discontinued immediately and a pediatric cardiologist or a pediatric intensive care specialist should be contacted to discuss the ECG result.
2. Waist Circumference evaluation, fasting glucose and Glycosylated hemoglobin (HbA1c) as clinical laboratory testing and Possibly Suicide-Related Adverse Events (PSRAEs) monitoring were included.
4. Benzhexol, other anticholinergics and Steroids (except inhaled, if taken at least 2 months before study with stable dose and clinical condition) were included in concomitant medications.
5. It was recommended that subjects should complete the Central nervous system (CNS) Vital Signs battery before any intrusive assessments such as blood draws, if at all possible.
6. Exposure In utero definition was amended to include paternal exposure.
7. 8. For safety, for those subjects who were randomized to placebo in the double-blind study, baseline values was to be the observation prior to dosing for ECG and blood pressure/pulse only, initiating dosing in the open-label extension study. |
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17 Jan 2007 |
1. To assess risks related to the possible prolongation of the QT interval, subjects with QTcF ≥440 460 msec or with risk factors for QT prolongation were to be excluded. Extensive ECG monitoring was to be performed throughout the study, including triplicate ECGs at baseline (3 timepoints).
2. Concomitant medication section amended to include trihexyphenidyl hydrochloride (HCl) and exclude Benzhexol. |
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13 Nov 2007 |
1. Trial treatment section was amended to include drug blister card design to decrease the chance for dosing errors (usually overdosing). |
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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 AE tables were amended to incorporate previously unreported AEs that were found during an independent audit and verified by the investigators. |