EFFECTS OF DIMETHINDENE MALEATE ON PSYCHOMOTOR PERFORMANCE IN THE OCULODYNAMIC TEST COMPARED WITH PLACEBO AND LORATADINE

The effects of dimethindene maleate (CAS 3614-69-5) on the central ner vous system - as sustained release pellets (Fenistil(R) OAD; OAD = onc e a day) and sustained release tablets (Fenistil retard) with an immed iate release fraction - were investigated by means of the oculodynamic test (ODT) and visual analogue scales and compared to loratadine (CAS 79794-75-5) and placebo. In the confirmatory part of the study 18 hea lthy volunteers were included in a single-blind, randomised, 3-way cha nge-over design with Fenistil OAD, loratadine, and placebo. An additio nal, fourth exploratory arm with Fenistil retard was run in 6 (out of the 18) subjects after completing the main part of the study. The ODT includes electro-oculography, choice reaction task, and cardiologic pa rameters under workload. Visual analogue scales were used for subjecti ve ratings on well-being and drug effects concerning wakefulness (seda tion), excitation, dizziness, performance, effort, and dry mouth. The results show no relevant differences between either of the active drug s and placebo. Therefore it can be stated that after a single dose the re is no sedating effect of dimethindene maleate compared to loratadin e or placebo.