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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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003735 |
E.1.2 | Term | Attention deficit-hyperactivity disorder |
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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 main goal is to perform this pilot study where we try to duplicate some of the results of other recent experiments and show we can do at least as well, preferably better. Furthermore, using a CNS drug enhancer, we intend to measure the effect of a common AD/HD treatment on the EEG of AD/HD patients, thus hoping to get a high degree of separation of individuals belonging to various subgroups of AD/HD. The main objective of using a CNS drug enhancer is to determine if there are any features of the EEG that can predict success of treatment for a given individual who has been diagnosed with AD/HD. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Healthy subjects: – Male – Between 6-8 years of age – On the parent-completed SDQ, scores on the four proplem subscales (Hyperactivity, Emotional Problems, Conduct Problems, Peer Problems) should not exceed 1.0 standard deviation above the age appropriate mean. On the AD/HD Rating scale-IV, Inattention and Hyperactivity subscores should not exceed one standard deviation above the mean. The means and standard deviations mentioned here refer to Icelandic norms. AD/HD subjects: – Male – Between 6-8 years of age – Recently diagnosed with AD/HD according to DSM-IV – Other possibilities have been exhausted and treatment using methylphenidate (Ritalin®) is the only viable option left
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E.4 | Principal exclusion criteria |
– Individual has Tourette syndrome – Individual suffers from psychosis – Individual suffers from mental retardation – Individual allergic to the investigational material – Individual is receiving treatment for other diseases affecting the central nervous system – Hypersensitivity to methylphenidate or any other component in the Ritalin® formulation – Participation in another investigational study at the same time
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E.5 End points |
E.5.1 | Primary end point(s) |
The endpoint of the study is to have 120 EEG measurements from two groups of 40 boys. 80 EEGs from a group of 40 boys who have recently been diagnosed with ADHD and are between 6 and 8 years of age and 40 EEGs from another group of 40 healthy age matched boys. The clinical group is measured before and after Ritalin® administration. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Only patient group receives IMP |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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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Last visit of the last subject. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |