Have the clinical trials been approved ?
Based on data from the previous clinical studies, the European Medicines Agency gave its agreement to set-up the two present clinical studies, that have then been submitted for approval by Competent Authorities and/or an Ethics Committee of the participating countries.
How many visits will there be during the study?
During the first 6 months: your child will need to visit the research site. Around once every week during the first month of the study then s/he will visit the research site approximately every month.
The same visit frequency (once a week and then every month) will occur during the last 6 months.
There will be a total of 21 visits over the 1 year that the study lasts.
How will the effects of the medication be measured?
Specific questionnaires will be used to measure any changes in symptoms.
The healthcare team will complete some questionnaires by interviewing you or observing your child’s behaviour and you will complete some questionnaires on paper at different time points during the study.
Your motivation and participation are very important for the evaluation of the tested medicine.
Will there be any side effects?
It is important to report anything unusual to the research team straight away. While participating in this study, your child will receive regular medical tests including blood, urine, kidney and heart tests (electrocardiogram, blood pressure) to check for any side effects. The research team will closely monitor any side effects and will recommend potential treatments, if necessary.
If you go further in considering study participation, complete information about study visits, exams and risks will be provided in an information and consent form.