E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Open treatment with atomoxetine for 10 weeks: •Week 1: 0,5 mg/kg/day in 1 or 2 doses. •Week 2 – 6: 1,2 mg/kg/day i 1 or 2 doses. •Week 6 – 8: Significant improvements: Continue on 1,2 mg/kg/day in 1 or 2 doses. Not improved: 1,4 mg/kg/day in 1 or 2 doses. There will be medical consultations at week 1, 2, 4, 6 and 10 weeks. Patients or parents can contact the doctor in between if needed.
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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 |
Research questions are: • What percentage of patients with PDD + ADHD will show clinically signifiacnt improvemnets of their ADHD symptoms when they are treated with atomoxetine? • Are there differences in effects on symptoms of hyperactivity and impulsivity versus symptoms of inattention? • What kind of side effects are reported?
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Inclusion criteria are: • Fullfill criteria for the diagnosis Pervasive Developmental Disorder • Fullfill criteria for the diagnosis Attention Deficit Hyperactivity Disorder • Age: 6 – 18 years |
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E.4 | Principal exclusion criteria |
Cooccuring medical condition that contradict treatment with atomoxetine, e.g. allergy to the substance.
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E.5 End points |
E.5.1 | Primary end point(s) |
Effekts of atomoxetine will be assessed by using: - ADHD Rating Scale filled out by parents and teachers - Assessment of general health,symptoms, and daily functioning by the physician at the regualar visits. - Clinical Global Improvements (CGI)
At visits all ”adverse events” will be recorded.
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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 | 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 | 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 | No |
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 | No |
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
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E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
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 | Information not present in EudraCT |
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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After the trial periode the responsible physician will discuss with the patient and the parents the indication for further treatment with atomoxetine. If the patient should be treated, such treatment will be provided by the reserach physician or the general practitioner (fastlege). |
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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 | 12 |
E.8.9.1 | In the Member State concerned days | |