E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Attention Deficit Hyperactivity Disorder |
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E.1.1.1 | Medical condition in easily understood language |
being hyperactive and/or inattentive |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003735 |
E.1.2 | Term | Attention deficit-hyperactivity disorder |
E.1.2 | System Organ Class | 100000004873 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The purpose of this trial is to determine if the study medication, CONCERTA (methylphenidate HCl), is safe and effective in improving academic performance and behavior in children with Attention Deficit Hyperactivity Disorder (ADHD) when compared to placebo. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- ADHD diagnosis of all subtypes (except Not Otherwise Specified)
- Patients with total or subscale Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS-IV) scores > =90th percentile relative to the general population of children by age and gender
- Patients currently receiving ADHD medication must be inadequately managed on their current stimulant dose and meet this criteria at the screening visit
- Ability to read and understand English
- Ability to attend school regularly |
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E.4 | Principal exclusion criteria |
- Estimated Full Scale IQ score of 80 or below, Severe Learning Disability
- History of or current, primary diagnosis of: severe anxiety disorder, conduct disorder, psychotic disorders, Pervasive Developmental Disorder, Eating Disorder, Obsessive-Compulsive Disorder, Sleep Disorder, Major Depressive Disorder, Bipolar Disorder, Substance Use Disorder, Chronic Tic Disorder, personal or family history of Tourette's Syndrome
- Weight < 3rd percentile for age
- History of hospitalization for treatment of a mood, anxiety, or psychotic disorder
- History of failed response to methylphenidate |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted)
- Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the Hour stated above of the of the Lab School Day during Double-Blind Assessment Period |
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E.5.2 | Secondary end point(s) |
- Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Deportment (SKAMP-Deportment)
- Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Attention (SKAMP-Attention)
- Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Composite (SKAMP-Composite)
- Hour 5.5 Test of Variables of Attention (TOVA) ADHD Score
- Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time (msec)
- Hour 5.5 Test of Variables of Attention(TOVA) Reaction Time Variability (Standard Deviation in milliseconds (msecs))
- Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Backwards
- Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Forwards
- Hour 5.5 Test of Variables of Attention (TOVA) Commissions
- Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Backwards
- Hour 8.75 Gray Silent Reading Test (GSRT)
- Hour 7.5 Test of Handwriting Skills (Revised) (THS-R)
- Hour 3.5 Dynamic Indicators of Basic Early Literacy Skills (DIBELS)
- Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Forwards
- Hour 5.5 Test of Variables of Attention (TOVA) Omissions
- Hour 3.0 Grammar Task
- Hour 8.75 Packet Activity - Short Story with Questions for Comprehension
- Hour 8.75 Packet Activity - Identiy Root Word
- Hour 8.75 Packet Activity - Alphabetize list of words
- Hour 8.75 Packet Activity - Identify multiple meanings for words
- Hour 8.75 Packet Activity - Complete sentences using words provided
- Hour 8.75 Packet Activity - Word search
- Hour 8.75 Packet Activity - Decode the mystery sentence |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At the Hour stated above of the of the Lab School Day during Double-Blind Assessment Period |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial months | 6 |