E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Attention deficit and hyperactivity disorder in childhood |
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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 |
Main efficacy criterion: Treatment difference in score change (day 56 to day 0) in ADHDRS-IV-Parent Version (18-Item-Scale): Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) between verum vs. placebo (see Planning of the determination of sample size for the confirmatory analysis in chapter 13.1) |
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E.2.2 | Secondary objectives of the trial |
Secondary efficacy criteria: - Treatment difference in percentage of patients with at least 25% reduction of the ADHDRS-IV-Parent Score (according to atomoxetine study versus placebo, CT Registry ID#2746, Study B4Z-MC-LYAT) - Treatment difference in score difference Montgomery-Åsberg-Depression Rating Scale between day 1 minus day 56 to assess emotional well-being - Treatment difference in Clinical Global Impressions CGI Item 1: Improvement by ≥ 2 categories - Treatment difference in Clinical Global Impressions CGI Item 2: much or very much better - Treatment difference in Clinical Global Impressions CGI Item 3: at least marked improvement - Treatment difference in Continuous Performance Test - Treatment difference in spontaneous movements measured by Doppler radar actometry
Safety criteria: - Treatment difference in spontaneous reporting of adverse events - Treatment difference in 17-Item Barkley´s Side Effects Rating Scale
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Written Informed Consent by parents and patients (separately for age groups 6 – 11 years and 12 – 17 years) - Children and adolescents of both sexes in the age group between 6 and 17 years - Confirmed diagnosis of ADHD by semi-structured clinical interview K-SADS verified (score ADHDRS-IV-Parent Version (18-Item-Scale): Investigator Administered and Scored ≥24) - Acceptance and Capability to swallow capsules of size 1 - Sufficient knowledge of the German language - Sexually mature and active adolescents with highly effective methods of birth control: contraception according to Pearl-Index<1; when use of oral contraceptives, additional methods of contraception (e.g. condomes) are necessary, i.e. double-barrier
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E.4 | Principal exclusion criteria |
- Known hypersensitivity against St. John´s wort or Valerian root or one of the excipients - Known hypersensitivity of the skin when exposed to sunlight - All serious internal diseases, and for this reason: - Current intake of following medication: Ciclosporin, Tacrolimus, Indinavir and other protease inhibitors in the anti-HIV treatment, Irinotecan and other cytostatics, anticoagulants of the Cumarin-type, Digoxin, Amitriptylin, Nortriptylin, Midazolam, Theophyllin or other medication with photosensitive effects - All severe psychiatric diseases except oppositional defiant disorders (according to items 21-28 SNAP-IV) and conduct disorders (according to items 41-45 SNAP-IV), and for this reason: - Current intake of the following medication: antidepressants and other psychotropic medication - Indication for hospitalization - Suicidality (including suicidal thoughts): Score ≥3 in item 10 of MADRS - Pregnancy, lactation - IQ < 70 - Positive screening for metabolites of illegal drugs in urine - Previous medication with stimulants and/or atomoxetine - Psychotropic co-medication - Placement in an institution on official or judicial ruling - Lack of willingness to store and transmit pseudonym data according to German regulations - Parallel participation in another clinical trial according to German Drug Law (AMG), or less than 4 weeks ago - Patients requiring a primary medication with methylphenidate during the study period of 8 weeks
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E.5 End points |
E.5.1 | Primary end point(s) |
Score change from baseline of the ADHDRS-IV-Parent Version (18-Item-Scale): Investigator Administered and Scored
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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 | 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 | Yes |
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.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
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 | Yes |
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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End of the trial will be the date of the completion of the last visit of the last subject undergiong the trial. For following reasons the trial can be terminated prematurely: -decision of the PI with regard to a new risk-benefit-evaluation (e.g. occurrence of non-justifiable risks and toxicities) -new scientific cognitions which do not justify further continuation -non-sufficient recruitment
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |