E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05] |
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 |
To compare sleep depivatiion and melatonin as sleep-inducing methods
prior to sleep EEG in children with suspected epilepsy, with regard to
prevalence of epileptiform activity |
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E.2.2 | Secondary objectives of the trial |
1. To compare sleep depivatiion and melatonin as sleep-inducing methods
prior to sleep EEG in children with suspected epilepsy, with regard to prevalence of sleep
2. To compare sleep depivatiion and melatonin as sleep-inducing methods
prior to sleep EEG in children with suspected epilepsy, with regard to technical quality ocf EEG;
3. Examine associations between the age of the child, salivary cortisol
and melatonin concentration prior to the EEG recording and the
likelihood of the child falling asleep after melatonin ingestion vs. sleep
deprivation.
4. To examine whether salivary levels of melatonin and cortisol are
affected by sleep deprivation in children.
5. To identify factors of relevance for sleep and sleep quality in children
of various ages between one and 16 years of age.
6. The experience of the investigation by children, parents and
technicians. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Children 2 to 17 years of age sent to EEG examination during sleep
because of suspected epilepsy.
Written consent of participation in the study given by parents and
children from 8 years of age. |
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E.4 | Principal exclusion criteria |
1. Difficulties understanding swedish by children and/or parents.
2. Severe mental redardation of the child.
3. Known or suspected allergy to melatonin.
4. Liver or kidney falure;
5.Ongoing medication with kinolones, fluvoxamin, 5-och 8-metoxipsoralen, cimetidin, or oestrogenes.
6. Pregnancy or breast-feeding |
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E.5 End points |
E.5.1 | Primary end point(s) |
Presence of epileptiform activity |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1.. Presence of sleep during the examination.
2. Technical quality of the EEG recording.
3. The experince of the melatonin compared to sleep-deprived sleep-EEG
by children, parents and technicians.
4. Cortisol and melatonin levels in saliva prior to melatonin intake.
5. Subjective sleep quality. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 | 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 | Yes |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 3 |
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 | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |