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 |
Attention-Deficit/Hyperactivity Disorder |
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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 | 23.0 |
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 primary objective of this study is to test the hypothesis that atomoxetine given orally once daily for approximately 16 weeks will provide superior efficacy compared to placebo for the treatment of ADHD in children and adolescents with ADHD and comorbid Dyslexia (ADHD+D) as measured by the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv). |
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E.2.2 | Secondary objectives of the trial |
1) To assess the effect of atomoxetine versus placebo for approximately 16 weeks on the secondary measures (see section E.5.2) 2) To assess the safety and tolerability of atomoxetine over approximately 16 and 32 weeks in the ADHD alone group, ADHD+D group, and dyslexia alone group as assessed by laboratory, vitals, and ECG measures and adverse events elicited during open-ended questioning. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•patients must meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for Attention-Deficit/Hyperactivity Disorder (ADHD) •patients must achieve a score of 80 or more on the Full Scale Intelligence Quotient •child or adolescent patients must be 10 to 16 years old •must be able to communicate in English •must be able to swallow capsules •be reliable to keep appointments for clinic visits and all related tests
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E.4 | Principal exclusion criteria |
•patients who weigh less than 25 Kg or greater than 70 Kg •patients with a history of alcohol or drug abuse on a repeated basis within the past 3 months •patients with documented history of autism, Asperger's syndrome or pervasive developmental disorder •females who are pregnant or breastfeeding •patients with a history of severe allergy to more than one class of medications •patients with documented history of bipolar I or bipolar II disorder, or psychosis
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E.5 End points |
E.5.1 | Primary end point(s) |
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score - Parent Version at Week 16 Endpoint |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
a) Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint b) Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 16 Endpoint c) Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint d) Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint e) Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 16 Endpoint f) Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 16 Endpoint g) Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint h) Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 16 Endpoint i) Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 16 Endpoint j) Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 16 Endpoint k) Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 32 Endpoint l) Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 32 Endpoint m) Change From Baseline in Woodcock-Johnson III Scores at Week 32 Endpoint n) Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 32 Endpoint o) Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 32 Endpoint p) Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 32 Endpoint q) Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint r) Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 32 Endpoint s) Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 32 Endpoint t) Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 32 Endpoint |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
a-j) Baseline, 16 weeks k-t) Baseline, 32 weeks |
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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 | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
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 |
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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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LVLS (Last Visit of the Last Subject) |
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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 years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |