Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Teva and Eisei's Agilect has demonstrated improvement in Parkinson's disease symptoms in levopoda-treated patients, reducing 'off' time and improving motor symptom control in a multicenter trial.
Subscribe to our email newsletter
The positive effects seen with once-daily Agilect (rasagiline tablets) were similar to those seen in patients treated with entacapone, given with each levodopa dose, when compared to placebo.
The study, named LARGO, was an 18-week parallel trial implemented at 74 sites in Europe, Israel, and Argentina. The study included 687 Parkinson’s disease (PD) patients with a clinical diagnosis of idiopathic PD, who were experiencing motor fluctuations despite receiving optimized levodopa therapy with or without stable doses of other additional anti-PD drugs, including dopamine agonists and anticholinergic agents.
All patients received optimized levodopa and were randomized to receive Agilect 1mg once-daily, entacapone 200mg with each levodopa dose or placebo.
Patients receiving either Agilect or entacapone in addition to levodopa had similar significant reductions from baseline in average total ‘off’ time of 1.20 hours compared with a 0.4 hour reduction in ‘off’ time with placebo. Treatment also resulted in an increase in ‘on’ time, the majority of which was without troublesome dyskinesia.
Additionally, patients treated with once-daily Agilect demonstrated significant improvements in PD symptoms based on the unified Parkinson’s disease rating scale (UPDRS) motor sub-scale during ‘on’ and ‘off’ periods.
“Treatment regimens with other medications, such as a COMT inhibitor or dopamine agonists, have been shown to have some positive effect but also carry a more complicated administration and titration schedule,” said Professor Oliver Rascol of the department of clinical pharmacology at University Hospital, Toulouse, France, and principal investigator of the LARGO trial.
“The positive results seen in this trial, together with a once-daily dose that does not require titration, means that Agilect may offer patients a new treatment option for moderate-to-advanced PD.”
The results from the LARGO study are consistent with another pivotal adjunct therapy trial comparing Agilect versus placebo, published in the February 2005 issue of the Archives of Neurology.