E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Attention Deficit Hyperactivity Disorder (ADHD) |
Aandachtstdeficiëntie-/hyperactiviteitstoornis (ADHD) |
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E.1.1.1 | Medical condition in easily understood language |
Children with ADHD may have trouble paying attention, controlling impulsive behaviors (may act without thinking about what the result will be), or be overly active. |
Kinderen met ADHD kunnen moeite hebben met behouden van aandacht, controleren van impulsief gedrag (dingen doen zonder nadenken) of kunnen erg druk zijn. |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
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 |
Our overall objective is to investigate the acute effects of a single dosage of methylphenidate on behavior in the classroom and on cognitive functioning. By means of randomized, double-blind, placebo-controlled cross-over trials, we will test the hypothesis that after nine months of treatment with methylphenidate, the effects on classroom behavior, the performance on a neuropsychological test battery, and brain activity diminishes, compared to the acute effects of methylphenidate in drug naïve children. |
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E.2.2 | Secondary objectives of the trial |
To investigate the association between performance on neuropsychological tasks, brain activity, and classroom behavior. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Children between the ages 6 and 12, any ethnicity or cultural background • Who have been diagnosed with ADHD as confirmed with the Parent Interview for Child Symptoms (PICS) (obtained during routine clinical assessment) • Who are going to start methylphenidate as per clinical decision • No use of methylphenidate for the past six months • Have a bodyweight of at least 20 kilograms • Deemed reliable and compliant with the protocol • Parents (or the legal guardian) and children (twelve years) have provided informed consent to participate in the study.
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E.4 | Principal exclusion criteria |
• Intellectual disability (based on available IQ below 70 or the clinical opinion of the investigator, taking into account relevant psychosocial information, e.g. educational level/academic achievements; or as confirmed by the IDS-2 IQ screener obtained in each participant, see section 7.1.2) |
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E.5 End points |
E.5.1 | Primary end point(s) |
A significant better performance on the neuropsychological tasks, normalisation of brain activity and reduction of ADHD-related behaviour in the classroom after administration of methylphenidate compared to placebo. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
There will be a comparison between methylphenidate and placebo in drug-naïve children (week 1 and 2) and after nine months of treatment (week 39 and 40). |
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E.5.2 | Secondary end point(s) |
Not applicable as the secondary objectives are aimed at investigating the relationship between variables. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The relationship will be assessed after week 2 and after week 40. |
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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 | No |
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 | Yes |
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) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | No |
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.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |