Clinical Trial Results:
A prospective, open-labeled, multicenter study of optimal dosages of Osmotic Release Oral System (OROS)-methylphenidate in treating children and adolescents with Attention-Deficit Hyperactivity Disorder
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Summary
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EudraCT number |
2015-001218-92 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
17 Sep 2007
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Results information
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Results version number |
v1 |
This version publication date |
06 Jul 2016
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First version publication date |
31 Jul 2015
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Other versions |
v2 |
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 |
CON-KOR-012
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
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WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Janssen Korea Ltd
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Sponsor organisation address |
25th Floor LS Yongsan Tower, 191, Hangangno 2-GA Yongsan-Gu Seoul, Korea, Republic of, 140702
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Public contact |
Clinical Registry Group-JB BV , Janssen Research and Development , ClinicalTrialsEU@its.jnj.com
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Scientific contact |
Clinical Registry Group-JB BV , Janssen Research and Development , 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) |
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 |
17 Sep 2007
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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 |
17 Sep 2007
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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 purpose of this study is to evaluate the optimal dosages of Osmotic Release Oral System (OROS) methylphenidate in Subjects with Attention Deficit Hyperactivity Disorder (ADHD).
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Protection of trial subjects |
Safety were evaluated throughout the study by monitoring of adverse events (AEs), by rating symptom scale, performing laboratory tests, measurement of vital signs, and performing physical examinations.
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Background therapy |
- | ||
Evidence for comparator |
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Actual start date of recruitment |
21 Aug 2006
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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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 |
Korea, Republic of: 144
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Worldwide total number of subjects |
144
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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) |
121
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Adolescents (12-17 years) |
23
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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 was conducted in 7 hospitals from August 21, 2006 to September 17, 2007. | ||||||||||||||
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Pre-assignment
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Screening details |
A total of 145 subjects were enrolled in the study and 144 subjects started the study out of these 116 subjects completed the study and 29 subject’s withdrawal the study. | ||||||||||||||
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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 | ||||||||||||||
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Arms
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Arm title
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Concerta | ||||||||||||||
Arm description |
Methylphenidate HCl initially either 18 milligram (mg) or 27 mg for weight less than 25 kilogram (kg) and more than 30 kg, respectively, once daily orally. Initial dose was adjusted by the investigator based on the maintenance dose of a previous drug or clinical symptoms. | ||||||||||||||
Arm type |
Experimental | ||||||||||||||
Investigational medicinal product name |
Methylphenidate HCl
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Investigational medicinal product code |
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Other name |
Concerta
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Subject was administered the once daily dose of oral capsule of Methylphenidate hydrochloride in morning.
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Baseline characteristics reporting groups
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Reporting group title |
Concerta
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Reporting group description |
Methylphenidate HCl initially either 18 milligram (mg) or 27 mg for weight less than 25 kilogram (kg) and more than 30 kg, respectively, once daily orally. Initial dose was adjusted by the investigator based on the maintenance dose of a previous drug or clinical symptoms. | ||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Concerta
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Reporting group description |
Methylphenidate HCl initially either 18 milligram (mg) or 27 mg for weight less than 25 kilogram (kg) and more than 30 kg, respectively, once daily orally. Initial dose was adjusted by the investigator based on the maintenance dose of a previous drug or clinical symptoms. | ||
Subject analysis set title |
Intent-to-treat (ITT) population
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
ITT population included subjects who were administered with the study drug more than once and provided data for primary efficacy variables.
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End point title |
Percentage of Subjects with Remission at Week 12 [1] | ||||||||
End point description |
Remission is defined as the total score of [Korean Version of Adult Attention Deficit Hyperactivity Disorders (ADHD) Rating Scale] (K-ARS) below 18 points and a CGI below 2 (very much improved, much improved). Last observation carried forward (LOCF) was used to impute missing data.
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End point type |
Primary
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End point timeframe |
Week 12
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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: Statistical analysis was not reported for this endpoint as inferential analysis was not performed as planned. |
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| Notes [2] - ITT Population |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change in ADHD Diagnostic System (ADS) Score | ||||||||||||||||||||||||||||||||||||||||
End point description |
ADS is an objective and standardized Continuous Performance Test (CPT) to evaluate attention. Date for simple selective visual (ssv) and simple selective aural (SSA) were reported. LOCF was used to impute missing data.
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End point type |
Secondary
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End point timeframe |
week 12
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| Notes [3] - ITT Population |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||
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End point title |
Change From Baseline in Inattention/Over Activity With Aggression (IOWA) Conners Behavior Rating Scale - I/O Score at Week 12 | ||||||||||||||||||||
End point description |
IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Over activity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening. LOCF was used to impute missing data.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| Notes [4] - ITT Population |
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Change From Baseline in Children's Depression Inventory (CDI) Score at week 12 | ||||||||||||
End point description |
The CDI contains 27 items, and measures symptoms of depression in children and adolescents. The CDI ranges in score from 0-54, where higher scores are indicative of a greater number of symptoms. Changes in scores from Baseline to Week 12 were examined. LOCF was used to impute missing data.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| Notes [5] - ITT Population |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in State-Trait Anxiety Inventory for Children (STAI-C) score at Week 12 | ||||||||||||||||
End point description |
State anxiety is the temporary emotional state that can be induced by tension, worry and fear under special circumstances and tends to be changeable in the degree, and Trait anxiety reflects a stable tendency throughout life, and is a measurement used to determine personal differences in response to external threats. LOCF was used to impute missing data.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Change from Baseline in Total Yale Global Tic Severity Scale (YGTSS) Score at Week 12 | ||||||||||||||||
End point description |
The Yale Global Tic Severity Scale (YGTSS) is a semi structured clinician-rated instrument that assesses the severity and frequency of motor and phonic tics over the previous week. Five index scores are obtained during the assessment, where higher scores indicate greater frequency or severity. LOCF was used to impute missing data. LOCF was used to impute missing data.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| Notes [6] - ITT Population |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Change from Baseline in Life Participation Scale-Child (LPS-C) Score at Week 12 | ||||||||||||
End point description |
LPS-C is a short parent-rated scale that is designed to assess changes in adaptive functioning related to treatment for ADHD. This scale measures improvements in social, emotional, cognitive, educational, and affinitive (family, friends) functioning, which indirectly reflect improvements in executive functioning. Happy/social sub scores range from 0-18, and self-control sub scores range from 0-54. Total scores range from 0-72. Higher scores are better for LPS. LOCF was used to impute missing data.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| Notes [7] - ITT Population |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in Academic Performance Rating Scale (APRS) Score at Week 12 | ||||||||||||
End point description |
APRS scale measures four factors in elementary school children such as learning ability, academic performance, impulse control, and social withdrawal. In particular, it is excellent in assessing drug effect on the academic performance not measured by other scales. Score ranges from 19 to 95, higher score means better academic performance. LOCF was used to impute missing data.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| Notes [8] - ITT Population |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in Parenting Questionnaire Form at Week 12 | ||||||||||||||||
End point description |
It consists of 13 questions to evaluate the parental sense of competency (cognitive dimensions) and parental frustration and anxiety (emotional dimensions). It is rated from 1 to 5 points, and it is reversely rated for 5,6th questions. The questionnaire consists of two subcategories of ‘Sense of competency (Questions 1~9)’ and ‘Sense of anxiety (Questions 10~13)’, and the total score of each subcategory is 0 to 45 points and 20 points. A higher score in the ‘Sense of competency” subcategories indicates a high parental sense of competency, and a higher score in the ‘Sense of anxiety’ subcategories indicates high parental frustration and anxiety. LOCF was used to impute missing data.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| Notes [9] - ITT Population |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 12 | ||||||||||||
End point description |
The Clinical Global Impression Severity (CGI-S) rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening . LOCF was used to impute missing data.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| Notes [10] - ITT Population |
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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 |
Day 7 up to Day 84
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.0
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Reporting groups
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Reporting group title |
Concerta
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Reporting group description |
Methylphenidate HCl initially either 18 milligram (mg) or 27 mg for weight less than 25 kilogram (kg) and more than 30 kg, respectively, once daily orally. Initial dose was adjusted by the investigator based on the maintenance dose of a previous drug or clinical symptoms. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
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. | |||
| None reported | |||
