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.NeuroSearch has enrolled and dosed the first patients in a European Phase III study, thereby launching the pivotal clinical program with ACR16 for the treatment of Huntington's disease.
Subscribe to our email newsletter
The study is a multi-centre, randomized, double-blind and placebo-controlled study planned to include up to 420 patients. The patients are randomized to receive daily doses of either 45mg ACR16 (QD), 90mg ACR16 (BID) or placebo over 26 weeks of treatment. The study is performed at 25-30 centres in eight European countries including Austria, Belgium, France, Germany, Italy, Portugal, Spain and the UK.
The primary endpoint of the study is to assess the effect of ACR16 on Huntington’s patients’s voluntary motor function, including parkinsonism, gait/balance, hand functionality and bradykinesia measured by the modified Motor Score which is a subscale of the Unified Huntington’s Disease Rating Scale. Secondary endpoints in the study include the overall clinical impression of the patients, their cognitive function, neuropsychiatric symptoms such as depression and anxiety as well as assessment of the safety and tolerability of ACR16.