Pharmaceutical firm Boston Life Sciences has reached an agreement with the Food and Drug Administration for the phase III clinical trial of its radioimaging agent Altropane.
The product is under development by the Boston-based firm for the differentiation of Parkinsonian tremors from tremors due to non-Parkinsonian causes. The study will enroll at least 500 subjects (250 with Parkinsonian tremor and 250 with non-Parkinsonian tremor) in up to 25 centers in the U.S., most of which are university-based, the company said.
Subjects suspected of having the tremor will be referred to a neurology clinic for enrollment in the study. Upon diagnosis of Parkinsonian or non-Parkinsonian tremor by the subjects' internist or general practitioner, the subjects will be administered Altropane and a SPECT image will be obtained.
Primary analyses will comprise assessments of the sensitivity and specificity of the Altropane SPECT procedure versus the diagnosis of an internist or general practitioner. The primary endpoint of the study is to demonstrate statistically significant superiority of the Altropane scan diagnosis compared to that of an internist or general practitioner, Boston Life Sciences said.
By AuntMinnie.com staff writersApril 1, 2004
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