E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Attention-Deficit/Hyperactivity Disorder (AD/HD) |
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E.1.1.1 | Medical condition in easily understood language |
Attention-Deficit/Hyperactivity Disorder (AD/HD) |
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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 |
to test the hypothesis that acute treatment for approximately 4 weeks with atomoxetine provides superior efficacy compared with placebo in patients with Attention-Deficit/Hyperactivity Disorder-Combined Type (ADHD-C), Reading Disorder (RD) without ADHD, and comorbid ADHD-C and RD (ADHD-C+RD) as measured by improvement in speed of inhibition as shown by a statistically significantly shorter Stop Signal Reaction Time (SSRT) as derived from the Stop Signal Reaction Time Paradigm. |
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E.2.2 | Secondary objectives of the trial |
To measure: a) In the subset of patients aged 10 years and older, compare performance. b) Compare performance in: ADHD-C, RD, and ADHD-C+RD with the normal control and reading disordered control groups on SSRT and a reading task (lexical decision task). c) Establish the specificity of effect of atomoxetine upon SSRT and a phonological and lexical decision task. d) Determine the effect of atomoxetine compared with placebo upon impulsivity. e) Determine the effect of atomoxetine compared with placebo upon working memory f) Test the hypothesis that atomoxetine is superior to placebo in reducing symptoms of ADHD. g) Compare the clinical effect of atomoxetine to placebo in reducing symptoms of ADHD, using the Clinical Global Impression-Attention- Deficit/Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I). h) Compare the safety and tolerability of atomoxetine with placebo as assessed by adverse events (AEs) elicited during open-ended questioning. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Clinical diagnosis with Attention Deficit Hyperactivity Disorder and/or Reading Disorder. |
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E.4 | Principal exclusion criteria |
1) Patients with Conduct Disorder 2) Patients who have a history of Bipolar I or II Disorder, psychosis, or Pervasive Development Disorder. 3) Patients who have a current diagnosis of Vocal Tic Disorder, Obsessive Compulsive Disorder, Major Depressive Disorder, Post Traumatic Stress Disorder, Anxiety Disorder, and certain other learning disorders. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Stop Signal Reaction Time (SSRT) as Derived From the Stop Signal Reaction Time Paradigm |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline and Week 4 of initial therapy and Week 4 of crossover therapy
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E.5.2 | Secondary end point(s) |
a) Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset b) Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset c) Lexical Decision Task Mean Reaction Time: Correct Words d) Lexical Decision Task Mean Reaction Time: Pseudo Words e) Working Memory by Corsi Block Tapping Test (CBTT) f) Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total Score g) Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Inattention Subscale h) Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Hyperactivity-Impulsivity Subscale i) Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total T-Score j) Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale k) Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale l) Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudohomophones m) Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudo Words n) Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset: Pseudohomophones o) Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset: Pseudo Words |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
a, b) Baseline and 4 weeks of therapy c,d,e,f,g,h,i) Baseline and Week 4 of initial therapy and Week 4 of crossover therapy j,k) 4 week therapy endpoint l,m,n,o) Baseline and 4 weeks of therapy |
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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) | 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 |
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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 | 2 |
E.8.9.2 | In all countries concerned by the trial months | 8 |