Altropane pivotal trial agreement
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Boston Life Sciences will proceed with a single pivotal trial for its Parkinson's disease radioimaging agent Altropane under a special protocol assessment. Agreement was reached after "a number of teleconferences, meetings and protocol revisions occurring over an eight-month period in which the company and FDA refined the study design," BLS says. The study will enroll at least 500 patients (250 with PD tremor, 250 with non-PD tremor). Primary analyses will evaluate Altropane's sensitivity and specificity versus that of an internist/general practitioner in distinguishing PD tremors from non-PD tremors. The agent is also in Phase II studies for diagnosis of attention deficit/hyperactivity disorder...