Last Updated: 2008-06-13 14:48:01 -0400 (Reuters Health)
NEW YORK (Reuters Health) – Tesofensine, a monoamine reuptake inhibitor, demonstrated some beneficial effects in a pilot study of patients with advanced Parkinson’s disease and motor fluctuations, according to European researchers.
Dr. Olivier Rascol of University Hospital, Toulouse, France and colleagues conducted a study of 254 patients who were randomized to treatment with tesofensine ranging in dose from 0.125 to 1 mg per day or to placebo tablets.
Following 14 weeks of treatment with 0.5 mg tesofensine compared to placebo, there was a significant adjusted mean difference of -4.7 points in the Unified Parkinson Disease Rating Scale (UPDRS) subscale for activities of daily living plus the subscale for motor function, the researchers report in the May issue of the Archives of Neurology.
The off time, calculated from patients’ diaries, fell significantly in those given the 0.25 mg dose. However, overall, other doses did not lead to any significant changes.
The team found that as the dose increased, so did the plasma concentration, but there was no clear dose-response relationship. In addition, adverse events increased with dosage.
Nevertheless, serious adverse events were more frequently reported by placebo patients (12.2%) than by those receiving active treatment (5.9%).
The effective dosages of 0.25 and 0.5 mg per day "exhibited an acceptable safety profile" the researchers observe, and they conclude that these "pilot results deserve further exploration to better assess the benefit-risk ratio of tesofensine in the treatment of Parkinson’s disease."
Arch Neurol 2008;65:577-583.
Copyright Reuters 2008. Click for Restrictions