Lisuride sc infusion therapy has proved highly effective in reducing severe motor complications in patients with Parkinson
In longterm controlled double-blind study (CALIPSO), lisuride sc infusion therapy has proved highly effective in reducing severe motor complications in patients with advanced Parkinson's disease (PD) refractory to optimized oral therapy.
CALIPSO has been the first double-blind controlled study of a sc continuous infusion of a dopamine agonist in complicated advanced PD. In this study 66 PD patients (average age 62 years, 44 % females) with about 10hours of severe motor fluctuations ("off" + "troublesome dyskinesia") have been treated in a double blind core phase of the study over 6 weeks. Lisuride subcutaneous (sc) infusion was compared with optimized oral dopamine agonist therapy (ropinirole, pramipexole, cabergoline). Patients in the lisuride group received lisuride infusion + oral placebo - the control group received their pre-study oral dopamine agonists + placebo infusion. All other anti-Parkinson therapy including L-Dopa was kept constant. After finishing the core phase 49 patients (~75%) have chosen to continue lisuride sc infusion in the extension phase over 2 years.
In the efficacy results, lisuride sc infusion proved significantly superior to the oral dopamine agonists in better mobility (UPDRS III motor score) and less troublesome dyskinesias (UPDRS IV A dyskinesia score) in the same patients. Statistically significant improvement was also obtained in Clinical Global Impression (CGI) and Responder Rates, thus confirming the results from a previous open controlled study over 4 years (Stocchi et al. Brain 2002). A mean reduction of 4 hours (from ca 10 h at baseline) in "Off" and in "troublesome dyskinesia" (prim. endpoint) based on patient diaries was observed under lisuride sc therapy after 6 weeks treatment which came close to the 0,05 level of significance. Spontaneous day-to-day fluctuations might have a marked influence on the patients´ diary documentation whilst the clinical evaluation of PD symptoms is not affected.
In patients with complicated late stage PD who had been diagnosed refractory to optimized oral combination therapy, the CALIPSO results constitute a remarkable improvement which will be validated by further efficacy data during the extension phase and another confirmatory study in preparation.
According to axxonis, the results obtained are evidence that lisuride sc infusion fully replaces a maximum oral dopamine agonist therapy and improves at the same time motor function as well as dyskinesias without change in concomitant levodopa therapy. In the extension phase, the dose of levodopa can be gradually reduced. No new safety-relevant findings have been reported. Local tolerance of the lisuride sc infusion was good.
These results from the CALIPSO study as a whole confirm the strong efficacy and good tolerability of lisuride sc infusion in patients with treatment-resistant advanced PD compared to oral dopamine agonists (i.e. continuation of previous therapy) under double-blind conditions. A similar significant improvement in motor function and at the same time in dyskinesias without any modification of the levodopa dosage has not been described for any non-invasive drug therapy in a comparable population of patients with severe PD.
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