E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Attention Deficit Hyperactivity Disorder and Sleep Problems |
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E.1.1.1 | Medical condition in easily understood language |
Attention Deficit Hyperactivity Disorder and Sleep Problems |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04] |
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 |
Children ages 6-12 years diagnosed with Attention Deficit/Hyperactivity disorder ond verified sleep problems is included
the objective is to evaluate the effect of melatonin on sleep in children aged 6-12 years with ADHD who have delayed melatonin release and normal melatonin release respectively.
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E.2.2 | Secondary objectives of the trial |
to evaluate the effect of melatonin over time in children aged 6-12 years with ADHD who have delayed melatonin release and normal melatonin release respectively.
The effect is to be evaluated after 1 month, 3 months and 6 months.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Children aged 6-12 years referred to the child and adolescent psychiatric department for examination/treatment for ADHD.
Diagnosed with ADHD (ICD-10)
Sleeping problems verified by Sleep diary and Sleep Questionaire
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E.4 | Principal exclusion criteria |
Ongoing treatment for sleep disturbances (melatonin, other sleep-regulating medication, weighted blankets) (all purposes)
Autisme
IQ below 70
allergy to melatonin
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint: effect on Sleep onset latenty
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
All endpoint will be evaluated before start after 1, 3 and 6 month |
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E.5.2 | Secondary end point(s) |
Secondary endpoints
- Total Sleep Duration
- Number of awakenings
- Bedtime
- ”Lights out”
- Sleep onset
- Time for awakening
- Quality of life
- ADHD-symptoms
- Side effects
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
All endpoint will be evaluated before start after 1, 3 and 6 month |
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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 | 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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
Single blind not-randomised clinical trial |
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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 | 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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |