Abstract

An international clinical trial programme was undertaken to evaluate the clinical safety and tolerability of remoxipride during a 12 month long-term study and to evaluate safety, tolerability and efficacy of remoxipride for up to 6 months in a double-blind comparison with haloperidol. A total of 145 patients were treated with remoxipride for at least 12 months. In the double-blind evaluation 106 patients on remoxipride and 50 on haloperidol were included. The doses of remoxipride ranged between 90-600 mg daily and of haloperidol between 5-45 mg daily. The therapeutic efficacy of remoxipride obtained in short-term studies was maintained during long-term treatment in most patients and was similar to that of haloperidol. Remoxipride had a clear cut advantage concerning extrapyramidal symptoms and anticholinergic drugs were needed less frequently with remoxipride than with haloperidol. The tolerability and safety showed no clinically significant differences compared to the data from short-term studies. This indicates that remoxipride can be used safely and with maintained efficacy for long-term treatment.