Risk/benefit analysis
rash, seizures/epilepsy, grown-up, NF1, attention deficits
SIDE EFFECTS
There are known side effects of lovastatin (LOV) and lamotrigine (LTG). LOV and LTG are used in an off-label context and in a higher dosage as recommended in the Summary of Product Characteristics (SMPC) of the medicinal products. However, all side effects of the medication (LOV and LTG) have been described after longer application whereas in the present study patients will receive LOV only four times and LTG only one time. In one patient receiving LTG, a mild rash following the administration reported has been reported [A 4-day course of LOV has been used in an own study in The results of the present study may help to design long-term studies focusing on the therapeutic effects of LTG on synaptic plasticity and cognition in patients with NF1. It is intended to publish the results in an international scientific journal. The inclusion of minors from the age of 16 years is not considered to increase the risk of potential side effects since persons are considered to be grown-up at this age from a medical point of view. We do not expect significant differences in body weight or in the metabolism of both medications (LTG and LOV) in adolescents aged 16 years why an adaption of the dosage is not necessary. LTG is a safe and commonly used medication in the treatment of seizures/epilepsy in children and adolescents. For medications (LTG and LOV), the risk of side effects after a single dosage (LTG) and a 4-day course of LOV is not considered to be increased in adolescents. Moreover, we estimate the benefit of an early treatment of attention deficits with the medication to be higher than the risk of the treatment in this study. Side effects associated with LTG or LOV are closely monitored and handled as described above. In case of acute threatening of the patients, treatment will be handled as described in the emergency plan of the hospital.